Registration Dossier
Registration Dossier
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EC number: 943-016-1 | CAS number: -
Endpoint summary
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:
- In
a dermal sensitization study according to EPA OPP 81-6 (Skin
sensitization) with the test item in USP grade mineral oil, young adult
Hartley-derived albino guinea pigs (10/sex in the main test) were tested
using the modified Buehler assay (Douds, 1995).
1-chloro-2,4-dinitrobenzene (DNCB) served as positive control.
Regarding the Topical Range-Finding Studies, the results of the first range-finding study indicated that a test article concentration of 50% was considered appropriate for Induction. The results of the second range-finding study indicated that a test article concentration of 10% was considered appropriate for challenge.
In the Main Sensitization Study, following challenge with 10% w/v of the test item in USP grade mineral oil, the animal responses met the negative criteria for sensitization based on the evaluation criteria. Dermal reactions in all test and challenge control animals were limited to scores of 0 to ± (0% net responders). Group mean dermal scores were noted to be similar in the test animals as compared to the challenge control animals.
Following challenge with DNCB, 6/6 DNCB test animals were noted to have a substantially stronger dermal response than was observed in the corresponding DNCB control animals. Group mean dermal scores were also noted to be higher In the DNCB test animals as compared to those of the DNCB control animals.
The majority of sensitization study animals gained weight during the test period and generally appeared in good health. In this study, the test item is not a dermal sensitizer.
Migrated from Short description of key information:
Skin sensitisation: EPA guideline, modified Buehler Assay; guinea pigs; Not sensitizing.
Justification for selection of skin sensitisation endpoint:
best study available
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
- Justification for selection of respiratory sensitisation endpoint:
Not relevant. The substance is not volatile.
Justification for classification or non-classification
In accordance with EU CLP (Regulation (EC) No. 1272/2008), this substance does not meet the criteria for classification as a skin sensitizer.
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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