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China Drafted Two Animal Testing Alternatives for Skin Allergy and Eye Irritation

China drafted two animal testing alternative methods namely 1) In Chemico Skin Sensitization: Direct Peptide Reactivity Testing 2) Short Time Exposure in Vitro Test: Test for Assessment of Eye irritation. The draft is open for public consultation until Feb.15th 2018...

Takehome:

China drafted two animal testing alternative methods namely 1) In Chemico Skin Sensitization: Direct Peptide Reactivity Testing 2) Short Time Exposure in Vitro Test: Test for Assessment of Eye irritation. The draft is open for public consultation until Feb.15th 2018.

In Chemico Skin Sensitization: Direct Peptide Reactivity Testing

CFDA issued an alternative skin sensitization test to assess chemical ingredients used in cosmetics. The test is called direct polypeptide test method and will replace the white rabbit test which was previously used to assess skin sensitization. The "Direct Peptide Test" is an in-vitro alternative which can be used to examine the corrosivity of 10 kinds of chemicals. Compared with the test on white rabbit, this in-vitro test is more effective, faster and cheaper.

Annex: 10 chemicals Direct Peptide Test can assess

No.

Name

Character

Sensitization

T1

2,4-Dinitrochlorobenzene

solid

positive

T2

4-ETHOXYMETHYLENE-2-PHENYL-2-OXAZOLIN-5-ONE

solid

positive

T3

         Formaldehyde

liquid

positive

T4

         Benzalacetone

solid

positive

T5

         FARNESAL

liquid

positive

T6

         2,3-Butanedione

liquid

positive

T7

         1-Butanol

liquid

negative

T8

         6-Methylcoumarin

solid

negative

T9

Lactic acid

liquid

negative

T10

4'-Methoxyacetophenone

solid

negative

Short Time Exposure in- Vitro Test

The test uses white rabbit cornea cells to examine eye irritation. It is an in-vitro alternative to replace the animal eye irritation test. The new test method follows toxicological principles outlined in "Cosmetic Safety and Technical Standard 2015" and aligns with international eye irritation alternative testing method standards.

Annex: 18 examples of cosmetic ingredient may require STE in-Vitro Test

Tested Ingredients

CAS Number

Eye Irritation Impact

Benzyldodecyldimethylammonium bromide

8001-54-5

Category 1

Triton X-100

9002-93-1

Category 1

Acid Red 92

18472-87-2

Category 1

gamma-Butyrolactone

96-48-0

Category 2A

1-Octanol

111-87-5

Category 2A/B

Cyclopentanol

96-41-3

Category 2A/B

Dodecane

112-40-3

No Category irritating

4-Methyl-2-pentanone

108-10-1

No Category irritating

1,1-DIMETHYLGUANIDINE SULFATE

598-65-2

No Category irritating

Ethylene glycol monoethyl ether acetate

111-15-9

No Category irritating

Sodium hydroxide

-

Category 1

Propyl disulfide

629-19-6

No Category

Piperonyl butoxide

51-03-6

No Category irritating

Poly(ethylene glycol) 400(PEG-400)

25322-68-3

No Category irritating

N,N-Diethyl-m-toluamide

134-62-3

Category 2B

Bis[2-(2-hydroxyethoxy)ethyl] ether

17831-71-9

Category 1

2,5-Dimethyl-2,5-hexanediol

110-03-2

Category 1

Glycerol

-

No Category

Note: 1. No category: no/few irritation

     2. Category 2: 2A light irritation, 2B irritation

     3. Category 1: corrosion (irreversible damage)

In China, cosmetic testing methods still use animals, although China has already developed a basic system offering several alternatives and is in the process of developing a more comprehensive cruelty free cosmetic testing framework.

The 2 drafts are open for public consultation until February 15th 2018, and any suggestions can be raised on [email protected]

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