Registration Dossier

Administrative data

Description of key information

To evaluate the allergic potential of the test substance, a skin maximisation test (EU B.6, GLP) in ten test and five control guinea-pig was perfomed with a structural analogue (di-ammonium salt). The substance did not induce any dermal reactions in test animals unless yellow staining of the application site. Thus, the test substance is considered to be as non-sensitizing.

Key value for chemical safety assessment

Skin sensitisation

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

Read across justification

The test item was not tested for its allergenic potential. It is acceptable to derive the information on sensitization from experimental data of a structural analogue (di-ammonium salt) since both are salts with similar structures. In addition, the lower molecular weight of the analogue gives a safety margin (a detailed read across justification is given in CSR, Annex I).

Procedure and results

To evaluate the allergic potential of the substance, a skin maximisation test in guinea-pig was perfomed (Ciba 1994b). Ten test and five control guinea-pigs were used in this study. For induction of animals, three pairs of intradermal injection were made. 6 days later, topical induction in the same area was performed after treatment with sodium lauryl sulphate in petrolatum. Control and test animals were challenged topically two weeks after the topical induction application using the test substance, 70 and 35% w/v in distilled water.

No skin reactions or signs of toxicity were recorded. There were no dermal reactions, other than staining of the dose site, seen in any of the test animals.

Discussion

The test substance did not induce any dermal reactions in test animals unless yellow staining of the application site. Thus, the test substance is considered to be as a non-sensitizer.

Justification for classification or non-classification

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for skin sensitization under Regulation (EC) No. 1272/2008, as amended for the thirteenth time in Regulation (EU) 2018/1480.