Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Endpoint conclusion:
no study available (further information necessary)
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

According to Column 1 (standard information required) and Column 2 (specific rules for adaptation from Column 1) of Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) an extended one-generation toxicity study (OECD 443), basic test design (cohorts 1A and 1B without extension to include a F2 generation) needs to be performed in case the available repeated dose toxicity studies (e.g. 90-day study) indicate adverse effects on reproductive organs or tissues or reveal other concerns in relation with reproductive toxicity. No treatment-related effects were observed on all sexual organ weights, estrous cycle length and number, and sperm motility, count and percentage of abnormal sperms in a reliable 90-day repeated dose toxicity study in rat. The weight of the thyroid gland was increased in females and slight/minimal follicular hypertrophy/hyperplasia was seen in males and females at 1000 mg/kg bw/day and in males at 250 mg/kg bw/day also follicular hypertrophy/hyperplasia was seen. Hormones made in the thyroid gland are involved in the regulation of T-lymphocyte development and growth.The extended one-generation study is proposed to contain the developmental immunotoxicity cohort (DIT) due to the thyroid effects observed in the 90-day study. The reproduction-developmental screening study is waived, based on testing proposals for an extended one-generation toxicity study (OECD 443) and a developmental toxicity study (OECD 414) for ANNEX IX registration.

Effects on developmental toxicity

Effect on developmental toxicity: via oral route
Endpoint conclusion:
no study available (further information necessary)
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available
Additional information

According to Column 1 (standard information required) of Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), a pre-natal developmental toxicity study in one species is required for substances manufactured or imported in quantities of 100 tonnes or more (ANNEX IX). To fulfill these data requirements, an oral pre-natal developmental toxicity study in rat (OECD 414) is proposed.

Justification for classification or non-classification

Will be completed with the study results of the reproduction toxicity study and the developmental toxicity study.

Additional information