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Toxicological information

Carcinogenicity

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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

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.

Justification for classification or non-classification