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Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

The test substance was assessed for its skin sensitising potential using the Local Lymph Node Assay (LLNA) in CBA/CaOlaHsd mice (BASF SE, 2012). The study was performed according to OECD guideline 429 in compliance with GLP. Test item solution at 10, 25, and 50% (w/w) was prepared in the vehicle dimethylformamide. The highest concentration tested was the highest concentration that could be technically used.

The animals did not show any signs of systemic toxicity or local skin irritation during the course of the study and no cases of mortality were observed. A statistically significant or biologically relevant increase in ear weights was not observed in any treated group in comparison to the vehicle control group. Furthermore, the cutoff-value for a positive response regarding the ear weight index of 1.1 reported for BALB/c mice was not exceeded in any dose group

Stimulation Indices (S.I.) of 1.36, 1.42, and 1.10 were determined with the test item at concentrations of 10, 25, and 50% (w/w) in dimethylformamide, respectively. A statistically significant or biologically relevant increase in DPM value, lymph node weight and cell count was not observed in any treated group in comparison to the vehicle control group. Furthermore, the cutoff-value for a positive response regarding the lymph node cell count index of 1.55 reported for BALB/c mice was not exceeded in any dose group.

Conclusion: The test item was not a skin sensitiser under the test conditions of this study.


Migrated from Short description of key information:
Skin sensitisation (LLNA): not sensitising (BASF SE, 2012).

Respiratory sensitisation

Endpoint conclusion
Additional information:
Migrated from Short description of key information:
There are no data available concerning respiratory sensitisation.

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC):

The available experimental test data for skin sensitisation are reliable and suitable for the purpose of classification under Directive 67/548/EEC. No classification is warranted concerning skin sensitisation (data conclusive but not sufficient for classification). There are no data available concerning respiratory sensitisation (no classification due to lacking data).

 

Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008:

The available experimental test data for skin sensitisation are reliable and suitable for the purpose of classification under Regulation (EC) No. 1272/2008. No classification is warranted concerning skin sensitisation (data conclusive but not sufficient for classification).

There are no data available concerning respiratory sensitisation (no classification due to lacking data).

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