Registration Dossier
Registration Dossier
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EC number: 411-950-4 | CAS number: 96562-58-2 DHPPME; MAK-ME; MEHPOPS; R-MAQ-ME
Endpoint summary
Administrative data
Description of key information
Skin sensitisation: Under the conditions of this study, the test material was determined not to be a skin sensitiser.
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 material to act as a sensitiser was investigated in accordance with the standardised guideline EU Method B.5 under GLP conditions in a guinea pig maximisation test. The study was awarded a reliability score of 1 in accordance with the criteria set forth by Klimisch et al. (1997).
Following a pre-test to select doses, 10 female Dunkin Hartley guinea pigs were exposed to the test material in olive oil DAB 9 in both the induction and challenge phases of the study. At intradermal induction, the test material concentration was 5 % in in the vehicle and at percutaneous induction the test material concentration was 25 % in the vehicle. Twenty one days after the intradermal induction, the test and control animals (5 females) were exposed to the test material in olive oil DAB 9 at a concentration of 10 % in the challenge.
After intradermal induction well-defined erythema and slight oedema were observed at the injection sites of the control group animals and test group animals at which only Freund's adjuvant/0.9 % aqueous NaCl-solution (1:1) was applied. Injection of test material preparation in olive oil DAB 9 caused in the half of the injection sites well-defined erythema and slight oedema and in the other half necrotic skin changes and slight oedema. After application of test material preparation in Freund’s adjuvant/0.9 % aqueous NaCl-solution (1:1) the test group animals showed necrotic skin changes and slight oedema.
After percutaneous induction (25 % in olive oil DAB 9) necrotic skin changes and slight oedema could be observed in the test group animals (caused by the intradermal induction). The control groups which were applied with olive oil DAB 9 (vehicle) exhibited incrustation, partially open (caused by the intradermal induction) in addition to well defined erythema and slight oedema.
After the percutaneous challenge with the test material preparation no skin reactions were observed in any animal. Olive oil DAB 9 applied as vehicle did not cause any reaction.
Under the conditions of this study, the test material was determined not to be a skin sensitiser.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
In accordance with the criteria for classification as defined in Annex I, Regulation (EC) No 1272/2008, the substance does not require classification with respect to skin sensitisation.
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