Reaction products of 2-amino-4,6-dinitrophenol, 4-amino-5-hydroxy 2,7-naphthalenedisulfonic acid, 4-nitrobenzenamine and resorcinol, sodium salts

Endpoint summary

Description of key information

Not sensitising

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

The test has been conducted on the Similar substance 01, in according to the GLP procedure and in according to the following guidelines: OECD Guideline 406, EU Method B.6 and “Allergic Contact Dermatitis in the Guinea pig: Identification of Contact Allergens” Mangusson B. Kligman A.M., 1970 published by C. C. Thomas, Springfiels, Illinois, U.S.A.. During the first challenge procedure, no positive reactions were evident and no deaths occurred. Based on the results obtained is expected that the Similar substance 01 is non sensitising to the skin.

Based on the read-across principle, the result can be considered for the skin sensitization assessment of the registered substance.

Justification for read-across is detailed in the report attached to the IUCLID section 13.

Due to the results described above, the registered substance is considered non sensitizer for the skin.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Skin sensitisation

According to the CLP Regulation n. 1272/2008, substances shall be classified as skin sensitisers (Category 1) where data are not sufficient for sub- categorisation (1A and 1B) in accordance with the following criteria:

(a) if there is evidence in humans that the substance can lead to sensitisation by skin contact in a substantial number of persons; or

(b) if there are positive results from an appropriate animal test (according to 3.4.2.2.4.1).

Specific criteria of animal test:

when an adjuvant type test method for skin sensitisation is used, a response of at least 30 % of the animals is considered as positive.

For a non-adjuvant Guinea pig test method a response of at least 15 % of the animals is considered positive.

Furthermore, stimulation index of three or more is considered a positive response in the local lymph node assay.

Sub-category 1A

Substances showing a high frequency of occurrence in humans and/or a high potency in animals can be presumed to have the potential to produce significant sensitisation in humans. Severity of reaction may also be considered.

Specific criteria:

Local lymph node assay-EC3 value ≤ 2 %

Guinea pig maximisation test- ≥ 30 % responding at ≤ 0,1 % intradermal induction dose or ≥ 60 % responding at > 0,1 % to ≤ 1 % intradermal induction dose

Buehler assay - ≥ 15 % responding at ≤ 0,2 % topical induction dose or ≥ 60 % responding at > 0,2 % to ≤ 20 % topical induction dose

Sub-category 1B

Substances showing a low to moderate frequency of occurrence in humans and/or a low to moderate potency in animals can be presumed to have the potential to produce sensitisation in humans. Severity of reaction may also be considered.

Local lymph node assay - EC3 value > 2 %

Guinea pig maximisation test- ≥ 30 % to < 60 % responding at > 0,1 % to ≤ 1 % intradermal induction dose or ≥ 30 % responding at > 1 % intradermal induction dose

Buehler assay - ≥ 15 % to < 60 % responding at > 0,2 % to ≤ 20 % topical induction dose or ≥ 15 % responding at > 20 % topical induction dose.

During the first challenge procedure, no positive reactions were evident and no deaths occurred. Based on the results obtained the Similar Substance 01is expected to be non sensitizer.

Based on the read-across principle, the results can be considered for the skin sensitization assessment of the registered substance.

As conclusion, according to the paragraph 3.4 of the CLP Regulation n. 1272/2008, the registered substance is not classified as skin sensitizer.