Cuprate(2-), [mu-[[3,3'-[methylenebis[(4,6-dihydroxy-3,1-phenylene)azo]]bis[4-hydroxy-5-nitrobenzenesulfonato]](6-)]], sodium potassium

Endpoint summary

Description of key information

Skin sensitising

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (sensitising)

Additional information:

One test is available on similar substance 1..

The test substance was tested for the assessment of skin sensitisation potential with the murine local lymph node assay, according to the OECD Guideline 429.

In this study the contact allergenic potential of the test substance was evaluated after topical application to female BALB/c mice. Mice were exposed to three concentrations of test substance suspended in vehicle DAE 433 (mixture of 40 % dimethylacetamide, 30 % acetone and 30 % ethanol) for 3 consecutive days. 

In pilot experiment the following concentrationsof test substance in application forms were used: 50 %, 5 %, 0.5 % (w/v). According to the results of pilot experiment the same doses were confirmed for main study. 

Primary proliferation of lymphocytes in the lymph node draining the site of application was evaluated using radioactive labelling of proliferating cells.

The evaluation of ear weight was performed for elimination of false positive findings with certain skin irritants.

 

The EC3 value calculated for the test item is 44.42 % with a SI of 3.12.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

SKIN SENSITIZATION

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 doseor ≥ 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.

Based on animal test (Local lymph node assay) results performed, according to the paragraph 3.4. of theCLP Regulation n. 1272/2008, the test substance is classified in Sub Category 1B, as the EC3 value is≤ 2% (EC3 = 44.42 %; SI = 3.12).