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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:

In a dermal sensitization study (Diesing, 1990) with Bayhibit AM-tetra-sodium salt (consisting of 64.7% water, 32.6% Bayhibit AM-tetrasodium salt, 1.3% Bayhibit AM-trisodium salt) in male Guinea pigs (DHPW: Dunkin, Hartley, Peruvian, Winkelmann) of 5-8 weeks and 365 g average weight at study initiation were tested using the method of Guinea Pig Maximisation Test (GPMT) according to Magnusson and Kligman. The intradermal induction was done with 5% test substance, followed by topical induction and challenge test, both with the undiluted (100%) test substance. The concentrations were chosen according to a pilot study. Before topical induction "pre-irritation" was induced by Sodium lauryl sulfate solution (10%). No skin reaction was observed in the treated group after the challenge test compared to the controls. Moreover, the test animals' body weight development was examined and they were observed for clinical symptoms. No difference was exhibited between the treated and the control groups. Therefore, it can be concluded that under the test conditions, the test substance Bayibit AM-tetra -sodium salt, is not a potential skin sensitiser.


Migrated from Short description of key information:
The skin sensitisation effect of Bayhibit AM-tetra-sodium salt was examined in guinea pigs by a Guinea Pig Maximisation Test (GPMT) according to Magnusson and Kligman. The test substance Bayibit AM-tetra -sodium salt, is not a potential skin sensitiser.

Justification for classification or non-classification

Based on the results of the Guinea Pig Maximisation Test (GPMT) according to Magnusson and Kligman with Bayhibit AM-tetra-sodium salt

- no skin reaction was observed in the treated group after the challenge test compared to the controls,

- no difference was exhibited between the treated and the control groups concerning body weight development, clinical symptoms Bayhibit AM is classified as not sensitizing according to EU Directive 67/548/EC and according to EU regulation No. 1272/2008 (GHS; amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006).