Registration Dossier
Registration Dossier
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EC number: 283-829-2 | CAS number: 84731-70-4
Carcinogenicity
Administrative data
Description of key information
For hazard considerations, it is considered not necessary to conduct a carcinogenicity study for this substance.
Key value for chemical safety assessment
Carcinogenicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Additional information
According to Regulation (EC) No. 1907/2006, Annex X, Section 8.9.1, Column 2: A carcinogenicity study may be required if:
1) the substance has a widespread dispersive use or there is evidence of frequent or long-term human exposure, and
2) the substance is classified as germ cell mutagen category 2 or there is evidence from the repeated dose study(ies) that the substance is able to induce hyperplasia and/or pre-neoplastic lesions.
For this substance, the substance is not classified as a germ cell mutagen. All the germ cell mutation studies give negative results, and in repeated dose studies, although it showed higher incidence of follicular cells hypertrophy in thyroid gland at high dose (1000 mg/kg) in 28-day study, it did not show that the substance is able to induce hyperplasia and/or pre-neoplastic lesions in 90-day study.
Hence for hazard considerations, it is not considered necessary to conduct a carcinogenicity study for this substance.
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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