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:

The potential of the test item, BENZOlC ACID ISONONYLESTER, to induce and elicit delayed dermal sensitisation was assessed by a guinea pig model using the maximisation test of Magnusson and Kligrnan. The concentrations of the test item used in the main study were detennined by the results of preliminary screening tests. The main sensitisation test was undertaken using a test group of 20 animals and a control group of 10 animals. In an attempt to induce sensitisation, test animals were intradermally injected with an emulsion of Freund's complete adjuvant and the test item at 20% concentration in both the selected vehicle (corn oil) and an emulsion of Freund's complete adjuvant. One week later this was boosted by topical application of the undiluted test item over the injection sites. Control group animals were treated in the same manner but the selected vehicle was used in place of the test item. Two weeks after the second induction stage, all animals were challenged by topical application of both the vehicle and the undiluted test item. At the challenge with the test item at 50% concentration no response to the test item was apparent in any animal of the test or control groups. No reaction to the vehicle alone was observed in any animal. These results indicate that the test item, BENZOIC ACID ISONONYLESTER, does not elicit a sensitisation response in the guinea pig, there being no reaction observed at challenge. European Directives concerning the classification, packaging and labelling of dangerous substances (67/548/EEC and subsequent revisions) would indicate the following: Classification : Not required; Symbol : None indicated; R Phrase : None indicated;


Migrated from Short description of key information:
The potential of the test item, BENZOlC ACID ISONONYLESTER, to induce and elicit delayed dermal sensitisation was assessed by a guinea pig model using the maximisation test of Magnusson and Kligman. The results indicate that the test item, BENZOIC ACID ISONONYLESTER, does not elicit a sensitisation response in the guinea pig, there being no reaction observed at challenge.

Justification for classification or non-classification

EU classification according to Annex VI of Directive 67/548/EEC: no classification required

GHS classification (GHS UN rev.2, 2007): no classification required

At the challenge with the test item at 50% concentration no response to the test item was apparent in any animal of the test or control groups. No reaction to the vehicle alone was observed in any animal. These results indicate that the test item, BENZOIC ACID ISONONYLESTER, does not elicit a sensitisation response in the guinea pig, there being no reaction observed at challenge. European Directives concerning the classification, packaging and labelling of dangerous substances (67/548/EEC and subsequent revisions) would indicate the following: Classification : Not required; Symbol : None indicated; R Phrase : None indicated;