Registration Dossier
Registration Dossier
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EC number: 268-697-6 | CAS number: 68133-69-7
Endpoint summary
Administrative data
Description of key information
Skin sensitising.
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
As no data on target substance was available, skin sensitising potential was assessed using a read across approach. Similar Substance 01 was used as read across substance and further details were reported in section 13.
Similar Substance 01 was tested using the LLNA:BrdU-ELISA method, described in OECD guideline 442B. A preliminary test was run using concentration between 1 and 25 % to identify a non toxic and minimally irritant concentration. No clinical signs or bodweight loss were noted; a concentration of 25 % was found to be not irritant. Based on results in preliminary test, a main test was run with concentrations of 5, 10 and 25 % w/w in acetone:olive oil 4:1 (v/v).
No mortality, clinical signs or significant changes in bodyweight were noted in the main assay. An increase in cell proliferation of draining lymph nodes occurred at all doses with SI of 3.03 at 5 %, 2.48 at 10 % and 3.09 at 25 %. As SI was greater than 1.6, a sensitising potential was associated to test substance.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
According to the CLP Regulation (EC 1272/2008):
Category 1
Substances shall be classified as skin sensitizers in category 1 where data are not sufficient for sub-categorisation in accordance with the following criteria:
(a) if there is evidence in humans that the substance can lead to sensitisation by skin contact in a substantial number of persons; or
(b) if there are positive results from an appropriate animal test.
As for LLNA, a stimulation index ≥ 3 is considered as a positive response.
Subcategorisation is done as follows:
Subcategory 1A
Substances showing a high frequency of occurrence in humans and/or a high potency in animals can be presumed to have the potential to produce significant sensitisation in humans. Severity of reaction may also be considered.
Specific criteria: EC3 value ≤ 2 %
Subcategory 1B
Substances showing a low to moderate frequency of occurrence in humans and/or a low to moderate potency in animals can be presumed to have the potential to produce sensitisation in humans. Severity of reaction may also be considered.
Specific criteria: EC3 value > 2 %
Based on data derived from LLNA, all tested concentrations (5 %, 10 % and 25 %) produced a stimulation index above 1.6, thus the substance was classified in category 1; as no concentrations below 5 % were tested, no sub-categorisation was possible.
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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