Reaction products of 6-amino-4-hydroxynaphthalene-2-sulphonic acid and 7-amino-4-hydroxynaphthalene-2-sulphonic acid, condensed with Formaldehyde and Sodium hydrogensulfite, coupled with diazotised Sodium 2-amino-4,6-dinitrophenoxide, metalized with Sodium Dichromate, sodium salts

Endpoint summary

Description of key information

not skin sensitiser

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

Skin sensitisation

The skin sensitisation potential of the substance was evaluated by considering data on the substance itself and data on Similar Substance 01. Justification for Read Across is given in Section 13 of IUCLID.

 

The sensitizing potential of Target Substance was tested after intradermal injections and cutaneous applications in ten male and ten female Albino Guinea Pigs, to the method established by B. Magnusson and A. Kligman *.

The intradermal induction was performed at the concentration of 2.5 % in distilled water. The epicutaneous induction and the challenge patch test were performed with the undiluted test sample. The behaviour of the animals was not influenced by the treatment. No local reaction could be observed 24 h and 48 h after removal of the challenge patch test due to the staining of the skin. Cutaneous samples of both flanks were taken and fixed in formalin 10 %. After histological examination, there was no evidence of a sensitization due to the test sample.

In conclusion, under our experimental conditions, the test sample did not provoke any cutaneous sensitization in the guinea pig.

 

* MAGNUSSON B. - KLIGMAN A.M. The identification of contact allergens by animal assay "The guinea pig maximization test". J. Invest.Derm. 1969,52,3,268-276

 

In order to evaluate the skin sensitisation potential of the Similar Substance 01, an in vivo maximization test on guinea pigs was performed according to the OECD guideline 406 (1981). A primary irritation experiment was performed in order to determine the test concentrations of the main study. In the main study the intradermal induction was made by injection at 5 % in physiological saline and 10 % using an the adjuvant Freund’s Complete Adjuvant; in the following epidermal induction 25 % of test item in water was used. After two weeks, the animals were challenged using doses of 0, 5, 10 and 25 % .

The substance resulted in a sensitisation rate of 0 % to the guinea pig after intradermal and epipidermal induction.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

In the CLP Regulation (EC 1272/2008), in the section 3.4 Respiratory or skin sensitisation, a skin sensitizer is defined as a substance that will lead to an allergic response following skin contact.

A substance 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).

If in order to evaluate skin sensitisation potential, a Guinea pig maximisation test is performed, a substance is classified as skin sensitizer sub-category 1B if ≥ 30 % responding at > 1 % intradermal induction dose.

 

Based on the results from the GPMT performed, the substance induces no reactions after the intradermal induction dose > 1 %. Therefore, the substance is not classified as skin sensitiser, according to the CLP Regulation (EC 1272/2008).