Benzoic acid, 2,3,4,5-tetrachloro-6-cyano-, methyl ester, reaction products with 4-[2-(4-aminophenyl)diazenyl]-3-methylbenzenamine and methanol sodium salt (1:1)

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

Read across justification

The skin sensitization potential of the test item was not evaluated; reliable, experimental data of an analogue are available.

The substances share high similaritiy in structure and have comparable physico-chemical properties. Both substances are solids of poor water solubility and insoluble in most of the common organic solvents. The molecular weight of both compounds is higher than 600 g/mol. The molecules includes phthalimid-like structures and bear the potential to release chlorinated phthalimid after enzymatic or bacterial cleavage. Therefore, this analogue substance was choosen to examine the skin sensitization potential.

Study

To assess the skin sensitizing potential of the test substance, a Local Lymph Node Assay (LLNA) was conducted in mice (CBA/CaOlaHsd). Test item suspensions at different concentrations (1, 2 and 5 % w/w) were prepared using DMSO as a vehicle. The animals did not show any signs of systemic toxicity during the course of the study and no cases of mortality were observed. On day 6, all test item treated animals showed scabby ear skin. A possible erythema of the ear skin could not be evaluated due to the colour of the test item. A statistically significant increase in ear weights was observed in the high dose group in comparison to the vehicle control group (p < 0.05). However, this was considered to be not biologically relevant, as the observed increase did not exceed the threshold value of 25% for excessive local skin irritation mentioned in OECD guideline 429. Nevertheless, the increase in ear weights indicates a slight irritant property of the test item. In this study Stimulation Indices (S.I.) of 0.83, 1.03 and 0.96 were determined with the test item at concentrations of 1, 2 and 5%, respectively. A statistically significant or biologically relevant increase in DPM values, lymph node weights and lymph node cell counts was not observed in any treated group in comparison to the vehicle control group. Furthermore, the cut-off value of 1.55 for a positive response regarding the lymph node cell count index reported for BALB/c mice was not exceeded in any dose group. Thus, the test item was not a skin sensitiser under the test conditions of this study.

Migrated from Short description of key information:
The skin sensitization potnetial of the test item was not evaluated; reliable, experimental data of an analogue are available. The test substance did not show a skin sensitising potential in the Local Lymph Node Assay (OECD guideline 429, GLP).

Justification for selection of skin sensitisation endpoint:
only one study available

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008 (CLP). As a result the substance is not considered to be classified for skin sensitisation under Regulation (EC) No 1272/2008.