Registration Dossier

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:

Dicarboxylic acid mixture was investigated in a study according to OECD TG 406; maximization test. Ten guinea pigs received 0.1% test compound in 0.9%NaCl in the presence of Freud's complete adjuvant during the intradermal induction and 10% test compound during the following dermal induction after application of 10% sodium lauryl sulfate to induce local irritation. The challenge was performed with 5% test compound for 24 hours and skin reaction was evaluated 24 and 48 hours after removal of the dressing.

After the challenge application, no cutaneous reactions were observed in the animals of the control group. In the treatment group, a discrete erythema was observed in 1/10 animals at the 24-hour reading and in another animal at the 48-hour reading. Dryness of the skin was also observed in 1/10 animals at the 48-hours reading only. The authors concluded that the test item should not be considered as a skin sensitizer.

Additional sources/reviews cited in chapter "Additional Toxicological Information" support that dicarboxylic acid mixture is not sensitizing.

Migrated from Short description of key information:
Dicarboxylic acid mixture did not show sensitization properties in a guinea pig maximization test. No experimental data concerning the respiratory sensitisation potential are available. Overall, respiratory sensitisation is not expected for dicarboxylic acid mixture.

Justification for classification or non-classification

No classification is required according to the classification criteria 67/548/EWG and regulation no. 1272/2008 (GHS).