Registration Dossier
Registration Dossier
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EC number: 457-320-2 | CAS number: -
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
The substance was tested in a Guinea-Pig Maximisation Test, which employs intradermal injection and use of adjuvant. Upon challenge with 0.5% test substance (the highest non-irritating concentration), six of the 20 animals treated with the test substance at induction showed Grade 1 erythema at the 24-hour observation, and four animals showed Grade 1 erythema at the 48-hour observation. The control animals showed no response to challenge. Upon rechallenge with 0.2% test substance, no responses were seen in either treatment or control animals. The substance was concluded to be a weak sensitiser in this test.
Migrated from Short description of key information:
The substance was concluded to be a weak sensitiser in a guinea-pig maximisation test.
Respiratory sensitisation
Endpoint conclusion
- Additional information:
- Migrated from Short description of key information:
No suitable data are available.
Justification for classification or non-classification
The substance was tested in a Guinea-Pig Maximisation Test, which employs intradermal injection and use of adjuvant. Upon challenge application, six of the 20 animals treated with the test substance showed slight and patchy erythema; the control animals showed no response to challenge. Therefore the substance was concluded to be a weak sensitiser in this test. In accordance with CLP, when an adjuvant type guinea pig test is used, a response of at least 30% of the animals (equivalent to six out of 20 animals) is considered as positive. Therefore, the substance is classified as a skin sensitiser (Category 1) under CLP.
There are no human or suitable animal data regarding the respiratory sensitisation potential of the substance. As the substance is only a borderline skin sensitiser according to CLP criteria, and as the potential for inhalation exposure to the substance will be negligible, no classification is proposed for respiratory sensitisation.
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