Registration Dossier
Registration Dossier
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EC number: 203-875-9 | CAS number: 111-49-9
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Additional information:
Sensitising properties of the test substance were investigated using a mouse ear swelling test (MEST). Therefore 10 -15 female CF-1 mice were treated under either epicutanous, open (standard) or occlusive (patch test) conditions. The test substance was applied as a 1% solution.
Using the standard protocol (epicutaneous open) the test substance showed sensitizing effects(40% sensitised; positive when left ear was at least 20% thicker than the right ear). Using the repeated patch protocol none of the animals showed a positive test result.The test substance was tested for sensitizing properties in a mouse ear swelling test (MEST) performed according to standard operating procedures in two different laboratories. In each lab the test substance was applied as a 1 % solution in acetone to 15 female CF-1 mice. Only one out of the tested 30 animals showed a positive response (i.e. left ear was at least 20 % thicker than the right ear).
In that same publication the authors mention unpublished data which would indicate that the submission substance has weak sensitising effects in guinea pigs (no further details available).
Migrated from Short description of key information:
Using the mouse ear swelling test for assessment of sensitising properties of the test substance revealed either ambiguous or negative test results. Taken from a secondary source there are indications that the submission substance has weak sensitising effects in guinea pigs (guinea pig maximisation test), but no detailed information is available.
Justification for classification or non-classification
The test results of one mouse ear swelling test (MEST) is negative, another MEST reveals ambiguous results and there is only a comment that the substance was shown to be a weak sensitiser in guinea pigs.
Taken together the results from the available data we must conclude that the results are equivocal concerning the sensitising property of the test substance. Morover the test substance is known to be corrosive and therefore testing for sensitisation proved to be rather difficult. Overall no classification according to Regulation (EC) No. 1272/2008 and Council Directive 76/548/EEC for skin sensitising properties is warranted.Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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