2-(4-amino-2-nitroanilino)ethanol

Endpoint summary

Description of key information

According to the result of the key study (Rosner, GLP, Klimisch 2, OECD 429) and to the CLP criteria, the test item HC Red No. 3 was classfied as Category 1A Strong sensitizer.

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (sensitising)

Additional information:

In order to assess the potential sensitizer adverse effect of the HC Red No.3, one key study was available:

A Local Lymph Node Assay was performed (Rosner, 2001, OECD 429, GLP compliant, Klimisch 2). Test item at concentrations of 0, 0.1, 0.25, 0.5, 1.0 and 2.5% HC Red 3 (w/v) in acetone:olive oil, 4:1 (v/v) was applied topically to the dorsum of each ear lobe of CBA/CaOlaHsd mice (25 µl per ear) once daily on 3 consecutive days.

On day 5, mice were injected intravenously with 250 µl of 3H-methyl thymidine. Five hours later, mice were euthanized and the draining auricular lymph nodes removed. Lymph nodes from each animal within a dose group were pooled and a cell suspension prepared. They were analysed by scintillation counter. No evidence of stimulating allergic contact sensitisation when HC Red n° 3 was tested at 0.1%, 0.25%, 0.5% and 1.0% (w/v) as the mean stimulation index did not exceed a value of 3, but HC Red n° 3 showed a positive lymphocyte proliferative increase when tested at 2.5% (w/v).

Justification for classification or non-classification

Under the experimental condition of the key study, the HC Red No. 3 at the concentration of 2.5% induced contact allergenic effect when administered to the dorsum of ear lobes in mice. HC Red n° 3 was sensitising when tested at 2.5%. Hence the test item was classified as sensitizer Category 1A strong sensitizer according to CLP criterias. However, this study had some deviations as the insufficient number of animals per group (3 were used instead of 4 required in the OECD guideline) but the results were still relevant.