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EC number: 701-196-7
CAS number: -
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), 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. Based
on the ECHA Final Decision, the extended one generation reproductive
toxicity study (OECD 443) is requested to be conducted in rats via oral
route with the registered substance and specified as follows:
- At least two weeks premating exposure duration for the parental (P0)
- Dose level setting shall aim to induce systemic toxicity at the
highest dose level;
- Cohort 1A (Reproductive toxicity);
- Cohort 1B (Reproductive toxicity) with extension to mate the Cohort 1B
animals to produce the F2 generation;
- Cohorts 2A and 2B (Developmental neurotoxicity)
For further information on the request of the ECHA Final Decision,
please refer to the attachements in IUCLID section 7.8.1.
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) will be conducted according to the ECHA Final Decision
(please refer to the attachements in IUCLID section 7.8.2).
Will be completed with the study results of the reproduction toxicity
study and the developmental toxicity study.
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.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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