cosmetic product safety report - eshop.ventobohemia.cz€¦ · noael 1000 mg/kg b.w./day...

of 21

Cosmetic product safety report

Commercial Name: Refreshing wet wipes “AURA Beauty”, 15 pcs

Data issued: 25.05.2018.

of 21

PART A - COSMETIC SAFETY REPORT

1. Qualitative and quantitative composition of the cosmetic product

INCI name Trade Name CAS number Function Concentration, (%)

Aqua Water 7732-18-5 Solvent to 100

Glycerine Glycerine 56-81-5 Humectants protections

0.300

Propylene Glycol Propylene Glycol 57-55-6 Humectants, Solubilizer,

moisturizing 0.100

Cocamidopropyl Betaine

Dehyton PK 45 147170-44-3 Surfactant 0.200

Polysorbate 20 Eumulgin SML 20 9005-64-5 Solubilizer 0.150

Oenothers Biennis Oil (Evening Primrose)

Vitamin A, E & F extract complex

90028-66-3

Skin Care Component

0.00002 – 0.002

Retinyl Palmitate Vitamin A, E & F extract complex

79-81-2 Skin Care

Component 0.00002 – 0.002

Tocopheryl Acetate

Vitamin A, E & F extract complex

7695-91-2 Skin Care

Component 0.00002 – 0.002

Phenoxyethanol Dekaben PBH 122-99-6 Preservative 0.400 – 0.600

Benzoic Acid Dekaben PBH 65-85-0 Preservative 0.080 – 0.200

Dehydroacetic Acid

Dekaben PBH 520-45-6 Preservative

0.080 – 0.200

Citric Acid Citric Acid 5949-29-1 Buffering 0.020

Parfum Starflower &

Argan 298963 - Parfum 0.150

of 21

2. Physical/chemical characteristics of the cosmetic product

Fabric:

Parameter Result

Appearance Non-woven fabric with embossing

Color From white to light yellow

Composition, % 20% viscose / 80% polyester

Perfume Neutral

Weight, g/m2 40 ±5

Width, mm 125 ±5

Hydrogen generator, pH 6,0 – 7,0

Technological solution:

Parameter Result

Appearance Transparent, with a light blue hue

Perfume Properly used fragrance

Hydrogen generator, pH 4,5 – 7,0

Cosmetic product:

Parameter Result

Appearance, color Wipe made from non-woven fabric, color from white to light yellow, evenly impregnated with solution.

Perfume Properly used fragrance

Hydrogen generator, pH 4.5-7.0

Moisture content, at least, % 50

Wipes dimension, mm: length width

185±5 125±5

of 21

3. Microbiology quality

Parameter Method Result

Candida albicans LVS EN ISO 18416:2009

Not detected in 0.5g (Sabouraud dextrose chloramphenicol agar)

Escheria coli LVS EN ISO 21150:2009

Not detected in 1g (MacConkey agar)

Mesophilic aerobic bacteria count LVS EN IS 21149:2009

<1 CFU/0,5g (Tryptone soy agar)

Pseudomona aeruginos LVS EN ISO 22717:2009

Note detected in 0,5g (Cetrimide agar)

Yeasts and molds ISO 16212:2008

<10 CFU/1g (Sabouraud dextrose chloramphenicol

agar)

Spahylococcus aureus LVS EN ISO 22718:2009

Not detected in 0,5g (Baird-Parker agar)

The cosmetic complies with the microbiological requirements Expected result (according to the

recommendations for cosmetic classified in Category 2).

Challenge Test (PN-EN ISO 11930:2012) - result confirms the effectiveness of conservation.

4. Stability of the cosmetic product and compatibility with package

Stability of the cosmetics product Stability test:

+40oC / +5oC – 4 weeks

No physicochemical changes. Stable

Compatibility with packaging Compatibility test: +40oC / +5oC – 4 weeks

No physicochemical changes. Consistent.

Shelf life is 2 years from the manufacturing date.

of 21

5. Impurities, traces, information about the packaging material

Package and sticker:

PACKAGE

Parameter Result

Thickness, µm 69

Material grammage, g/m2 70,82

Composition PET 12 / PE 50

STICKER

Width, mm 45

Length, mm 86

Composition Fasson PP90 TOP Clear-R1490M-BG40WH

Print method Flexographic printing, UV

Material thickness, µm 92

Material grammage, g/m2 83

Possible contamination with prohibited substances, such as heavy metals or residues of prohibited

substances, which are permitted only in trace amounts, provided that their number from a technological

point of view (manufacturing process) is inevitable.

The content of undesirable substances, heavy metals resulting from the contamination of raw materials

and the migration of the material in contact with the cosmetic product should not affect the safety of the

cosmetic.

6. Normal and reasonably foreseeable use

Cosmetic product designed for hygiene / refreshing – wet wipes.

A detailed description of the application on the product packaging.

7. Exposure to the cosmetics product

The reasonably foreseeable use Wet wipes

The foreseeable amount of product applied 0,530 g

The estimated number of application per day 5

Relative amount applied per day 44.167 mg/kg/day

The site of application Product for hygiene;

Possible contact with mucous membranes

The surface of area of application 800 cm2

Exposure per day 3.312 mg/cm2

Rinse off / Leave on Leave on

Retained material per day 3.312 mg/cm2

Retention factor 1

of 21

Routes of exposure (intentional and accidental):

Skin Contact.

Eye contact

Ingestion

Inhalation – unlikely that inhalation will be a rout of exposure

8. Toxicological profile of the substances

INCI name CAS numbers NOAEL mg/kg bw/day

SED mg/kg bw/day

MoS >100

Aqua 7732-18-5 - - -

Glycerine 56-81-5 1000 0.132 7575

Propylene Glycol 57-55-6 1700 0.025 68 000

Cocamidopropyl Betaine 147170-44-3 5000 0.088 56 818

Polysorbate 20 9005-64-5 2000 0.066 30 303

Oenothers Biennis Oil (Evening Primrose)

90028-66-3

- - -

Retinyl Palmitate 79-81-2 - - -

Tocopheryl Acetate 7695-91-2 500 0,00088 568 181

Phenoxyethanol 122-99-6 Annex V / 29. Max. authorized concentration: 1.0%

Benzoic Acid 65-85-0 Annex V / 1 . Leave-on products maximum concentration 0.5%

Dehydroacetic Acid 520-45-6 Annex V/13 . Maximum concentration 0.6% (as acid)

Citric Acid 5949-29-1 1200 0,0088 136 363

Parfum - - - -

of 21

9. Toxicological profile of substances

TRADE NAME: GLYCERINE

INCI NAME: Glycerin

CAS: 56-81-5

EINECS: 200-289-5

STRUCTURAL FORMULA:

Physical and chemical properties

Form: viscous liquid

Odour: odourless

Colour: colourless

pH value: not determined

Melting point: ~ 18 °C

Boiling point: ~ 290 oC

Flash point: 180 oC

Density: ~ 1,26 g/cm3 (20oC)

Sollubility in water: fully miscible

Margin of Safety

NOAEL 1000 mg/kg b.w./day

Toxicological Summary:

ACUTE ORAL TOXICITY: LD50 12600 mg/kg (rat) ACUTE DERMAL TOXICITY: LD50 >18700 mg/kg (rabbit) PRIMARY SKIN IRRITATION: Longer lasting and/or repeated skin contact may cause

irritation. PRIMARY EYE IRRITATION: Short time, reversible irritating effect SKIN SENSITIZATION: No sensitizing effect known.

of 21

TRADE NAME: PROPYLENE GLYCOL

INCI NAME: Propylene Glycol

CAS: 57-55-6

EINECS: 200-338-0

STRUCTURAL FORMULA:


Form: viscous liquid

Odour: odourless

Colour: colourless

pH value: 6,4 (500 g/kg, 20oC)

Melting point: -59 oC

Boiling point: 184oC (1003,2 hPa)

Flash point: 104oC

Flammability: not readily ignited

Density: 1,03 g/cm3 (20oC)

Margin of Safety

NOAEL - 1700 mg/kg b.w./day


Propylene glycol is an aliphatic alcohol widely used in cosmetics that functions as a skin conditioning

agent, viscosity decreasing agent, solvent, and a fragrance ingredient. Propylene glycol is generally

non-toxic and is non-carcinogenic.

of 21

ACUTE ORAL TOXICITY: LD50 > 2000 mg/kg PRIMARY SKIN IRRITATION: Not irritating to the skin PRIMARY EYE IRRITATION: Not irritating to eyes SKIN SENSITIZATION: Not sensitizing

TRADE NAME: DEHYTON PK 45

INCI NAME: Cocamidopropyl Betaine

CAS: 61789-40-0

EINECS: 263-058-8

STRUCTURAL FORMULA:


Form: liquid

Odour: odourless

Colour: yellow

pH value: 4,6 – 5,5 (25oC)

Dcomposition point: >= 208oC

Boiling point: > 100oC

Flash point: > 100oC

Flammability: not flammable

Density: 1,0600 – 1,0850 g/cm3 at 20oC

Margin of Safety

NOAEL - 5000 mg/kg b.w./day


ACUTE ORAL TOXICITY: LD50 > 5000 mg/kg (art) ACUTE DERMAL TOXICITY: LD50 > 2000 mg/kg (rat) PRIMARY SKIN IRRITATION: Not irritating to the skin PRIMARY EYE IRRITATION: May cause severe damage to the eyes SKIN SENSITIZATION: Not sensitizing

of 21

TRADE NAME: Eumulgin SML 20

INCI NAME: Polysorbate 20 CAS: 9005-64-5

EINECS: 500-018-3

STRUCTURAL FORMULA:


Form: liquid

Odour: slight odour

Colour: slight yellow

pH value: 6,0 – 7,5 Potassium chloride solution 0,03%, 20oC)

Melting point: approx.. 15oC

Boiling point: > 100 oC

Flash point: > 101 oC

Flammability: not flammable

Density: 1,0 – 1,2 g/cm3 at 20oC

Solubility in water: soluble

Margin of Safety


of 21


EUMULGIN® SML 20 (INCI: Polysorbate 20) is mainly used as a foaming agent in toothpaste, mouth gargles, and body cleansing preparations.

ACUTE ORAL TOXICITY: Assessment of acute toxicity: Virtually nontoxic after a single ingestion. Experimental/calculated data: LD50 2000 mg/kg (rat) PRIMARY IRRITATION:

Assessment of irritating effects: Not irritating to the skin. Nor irritating to the eyes

Experimental/calculated data: Skin corrosion/irritation rabbit: non-irritant Serious eye damage/irritation rabbit: Slightly irritating. RESPIRATION/SKIN SENSITIZATION: Assessment of sensitization: There is no evidence of a skin-sensitizing

TRADE NAME: VITAMIN A, E & F COMPLEX

INCI NAME: Tocopheryl Acetate

CAS: 7695-91-2

EINECS: 231-710-0

STRUCTURAL FORMULA:

INCI NAME: Oenothera Biennis (Evening Primrose) Oil

CAS: 90028-66-3

EINECS: 289-859-2

INCI NAME: Retinyl Palmitate

CAS: 79-81-2

EINECS: 201-228-5

STRUCTURAL FORMULA:

of 21


Appearance: clear pale yellow to yellow liquid

Odour: not determined


Melting point/freezing pint: not determined

Initial boiling pint/range: not determined

Flash pint: > 100oC

Relative density: 1,0950 – 1,1150


ACUTE TOXICITY: Based on available data the classification criteria are not met

Oral – Not Applicable

Dermal – Not Applicable

Inhalation – Not Available

SKIN IRRITATION: Based on available data the classification criteria are not met

EYE IRRITATION: Based on available data the classification criteria are not met

SKIN SENSITIZATION: Based on available data the classification criteria are not met

TRADE NAME: CITRIC ACID

INCI NAME: Citric Acid

CAS: 5949-29-1

EINECS: 201-069-1

STRUCTURAL FORMULA:

of 21


Form: solid, crystalinne

Odour: odourless

Colour: white

pH value: 1,7 (100g/l)

Melting point: approx.. 153oC at 1,013 hPa

Boiling point: decomposes before boiling

Flash point: Not known

Flammability: non flammable

Density: 1,665 g/cm3 at 20oC

Margin of Safety



INGESTION: LD50 5400 mg/kg bw (mouse)

INHALATION: no data

SKIN CONTACT: LD50 > 2000 mg/kg bw (dermal)

SKIN IRRITATION: mild skin irritation

EYE CONTACT: irritating

SKIN SENSITIZATION: not sensitizer

TRADE NAME: DEKABEN PBH

INCI NAME: Phenoxyethanol

CAS: 122-99-6

EINECS: 204-589-7

of 21

STRUCTURAL FORMULA:

INCI NAME: Benzoic Acid

CAS: 65-85-0

EINECS: 200-618-2

STRUCTURAL FORMULA:

INCI NAME: Dehydroacetic Acid

CAS: 520-45-6

EINECS: 208-293-9

STRUCTURAL FORMULA:

of 21


Physical state: liquid

Odour: characteristic

Colour: light yellow - yellow


Melting point: not determined

Freezing point: not determined

Boiling point: not determined

Flash point: not determined

Flammability: not relevant

Relative density: 1,126 – 1,132 at 20oC (water = 1)

Margin of Safety

NOAEL

Phenoxyethanol 200 mg/kg bw (oral feed, Wistar rat)

600 mg/kg bw (dermal, New Zealand white rabbit)

Benzoic Acid 500 mg/kg bw (rat)

Dehydroacetic Acid -


Test data are not available for complete mixture

ACUTE TOXICITY Harmful if swallowed

Acute toxicity estimate (ATE) of components of the mixture

Name of substance Exposure route ATE

Phenoxyethanol Oral 1,840 mg/kg

Benzoic Acid Dermal 2,000 mg/kg

Dehydroacetic Acid Oral 500 mg/kg

of 21

Acute toxicity of components of the mixture

Name of

substance Exposure route Endpoint Value Species

Phenoxyethanol oral LD50 2,740 mg/kg rat

Benzoic Acid

oral LD50 2,250 mg/kg mouse

Ingalation:

dust/mist LC50 >12,200 mg/m3/4h rat

dermal LD50 >2,000 mg/kg rabbit

Dehydroacetic

Acid oral LD50 500 mg/kg rat

SKIN CORROSION/IRRITATION: Causes skin irritation

SERIOUS EYE DAMMAGE/EYE IRRITATION: Causes serious eye damage

RESPIRATORY OR SKIN SENSITISATION: Shall not be classified as a respiratory or skin sensitiser.

Based on available data, the classification criteria are

not met.

CARCINOGENICITY: Shall not be classified as carcinogenic.

Based on available data, the classification criteria are

not met.

TRADE NAME: STARFLOWER & ARGAN 298963

Fragrance supplier certify that the fragrance compound is in compliance with the Standards of the

INTERNATIONAL FRAGRANCE ASSOCIATION (IFRA – 48th Amendment, notified 10.06.2015)

INCI NAME: Parfum

CAS: -

EINECS: -

STRUCTURAL FORMULA: -


Appearance: liquid

Color: characteristic

Odour: characteristic

pH value: not available

Melting point/freezing point: not available

Boiling point: not available

Flash point: Closed cup: 110 oC

of 21

Solubility in water: Non water-soluble liquid


There are no data available on the mixture itself

POTENTIAL ACUTE HEALTH EFFECTS

Eye Contact: No known significant effects or critical hazards

Inhalation: No known significant effects or critical hazards

Skin contact: Causes mild skin irritation. May cause an allergic

reaction

Ingestion: No known significant effects or critical hazards

10. Undesirable effect and serious undesirable effects

Not known.

If the supplier is aware of an abnormally high level of customer complaints the supplier must bring

this to the attention of the safety assessor and submit this formulation for reassessment and notify

the competent authorities of corrective actions taken.

11. Information on the cosmetic product

The product, wet wipes, with combination of ingredients that are commonly used in cosmetic

products of this type. All ingredients are legally permitted and are in concentrations allowed to be

used in cosmetics of this type. Concerning the skin tolerance the product is expected to be well

tolerated and to have a good cosmetic acceptability.

of 21

PART B – COSMETIC PRODUCT SAFETY ASSESSMENT

1. Assessment conclusion

Product: Refreshing wet wipes “AURA Beauty”, 15 pcs

It has been certified that the assessed cosmetic product meets the requirements established by

the European Parliament and Council Regulation (EC) No 1223/2009 of 30 November 2009. on

cosmetic products (OJ L 342, 22.12.2009) and applied in accordance with the specified purpose

and directions for use – does not constitute a threat to health.

2. Labelled warning and instructions of use

Specific warnings and instructions of use are written on the primary packaging as follows:

- DIRECTIONS: -

- CAUTION:

The product labelling and the general description of the product indicate the explicit use of the

finished product as a leave-on wet wipes for babies intended for daily use. A reasonably

foreseeable mistaken use additional to this use (not a misuse) is not recognisable.

The materials used in the assessed product are commonly applied within the cosmetics industry in

Europe and worldwide. All ingredients are used in accordance with their purpose and in the

correct proportions. The product is safe according to current state of science.

3. Reasoning

Physical/chemical characteristics, stability and microbiological quality of the cosmetic product

The stability data (microbiological and physical-chemical stability) of the formula after storage

meet the previously specified characteristics of the product specifications. They confirm a

sufficient stability of the tested formula.

Based on the tests of accelerated stability program that includes physical stability results,

analytical results and microbiological results: The shelf life for the final product is 24 months. The

final product is released with a date of minimum durability (DOMD) of 24 months. Based on the

above mentioned physico‐chemical and microbiological test results the product is rated as safe.

of 21

Packaging information The packaging of the product is made to protect the product during shelf life and use and to

enable the safe use of the product. Based on that the packaging is rated to be suitable and safe for

this specific product type. The package consists of a Printed foil (PET and LDPE) bags. This package

does not contain hazardous materials that require special markings or labelling on the shippers.

Normal and reasonably foreseeable use

The directions for use and the general description of the product on the label indicate the explicit

use of the finished product as a leave on wet wipes for babies. A reasonably foreseeable mistaken

use, (not a misuse) is not recognizable.

Exposure to the cosmetic product and the substances

The calculated margin of safety for ingredients, for which toxicological data were available, found

the safety factor to be acceptable.

In the case of components, in which no NOAEL makes impossible to calculate the margin of safety

of the traditional method, it can be concluded that at the concentrations used substances do not

pose a threat due to their low toxicity and a long history of safe use. These components do not

show a danger to people and do not adversely affect the safety of the final product.

Raw materials (impurities, traces, toxicological profile)

All materials used in the formula have been applied in accordance with their purpose, in a permitted quantity and do not constitute a threat to human health. The raw materials used to formulate this product are all well-known ingredients with a long

history of safe use.

Undesirable effects and serious undesirable effects

Not known.

If the supplier is aware of an abnormally high level of customer complaints the supplier must bring

this to the attention of the safety assessor and submit this formulation for reassessment and notify

the competent authorities of corrective actions taken.

of 21

Information on the cosmetic product

The product wet wipes may be used on daily basis.

The packaging of cosmetic product should include the following information in indelible, easily

legible and visible lettering

- Brand name

- Name of the product

- Function of the cosmetic product (unless it is clear from its presentation)

The following ingredients must be written on the packaging of the product: Aqua, Glycerine,

Propylene Glycol, Cocamidopropyl Betaine, Polysorbate 20, Oenothers Biennis Oil (Evening

Primrose), Retinyl Palmitate, Tocopheryl Acetate, Phenoxyethanol, Benzoic Acid, Dehydroacetic Acid,

Citric Acid, Parfum.

Concerning the skin tolerance, the final product is expected to be well tolerated and to have a good

cosmetic acceptability.

SUMMARY

The safety assessment is based on the chemical specification and toxicological profile of the ingredients as supplied at the time of assessment and an assessment of the final cosmetic product. The supplier to this safety assessment is advised to ask for a new safety evaluation if any change in formulation occurs, change in raw materials used, abnormally high number of adverse events are recorded, changes in recommended uses or other circumstances that may affect the safety of this product. Based on the outlined considerations the product is rated to be SAFE as stated in B.1.

of 21

Date and signature

All statements in this safety assessment were elaborated on the recent level of knowledge. Every change in

the formulation or changes and/or additional information of relevant data respectively will require an

immediate re-evaluation of this safety assessment.

Data issued: 25.05.2018

Prepared by: Technologist Viktorija Aksjonova

cosmetic product safety report - eshop.ventobohemia.cz€¦ · noael 1000 mg/kg b.w./day...

Documents