Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Endpoint conclusion:
no study available
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 Annex IX, 8.7.3 of REGULATION (EC) No 1907/2006 OF THE EUROPEAN PARLIAMENT (REACH), an extended one-generation reproductive toxicity study having regard to the likely route of human exposure, shall be proposed for substances within the tonnage band 100 - 1000 tpa, if the 90-day study or other available studies on reproduction indicate adverse effects on reproductive organs or tissues or reveal other concerns in relation with reproductive toxicity.

As discussed in more detail below, there is no evidence of substance-related effects as demonstrated in the available Repeated Dose 90-Day Toxicity study in rats.

A 90-day oral toxicity study similar to OECD TG 408 was performed with the test item. The test article was orally administered by means of a feed admix to Fü SPF albino rats of both sexes at daily dose levels of 50, 200, and 800 mg per kg bw for a period of 13 consecutive weeks. Animals of a control group received the normal rat maintenance diet without test article. All test groups comprised 10 males and 10 females. Mortality, clinical signs, body weights, feed intake, and water consumption were recorded. Eyes were examined. Haematology and biochemistry determinations were performed. All rats were autopsied and organs were weighed. Organs and tissues of the control and the high dosed rats were histopathologically examined. No deaths related to treatment occurred throughout the test period. The treatment with the test substance up to 800 mg/kg bw/day was well and asymptomatically tolerated. There were no adverse effects on body weight development and feed consumption. Slightly decreased PCV (packed cell volume) and RBC (erythrocyte count) values were considered to be a result of an increasing thirst effect of the test substance. Ophthalmoscopy, biochemistry, organ weighing, macroscopic and microscopic examination did not reveal undesired/ toxicological related effects. Thus, a NOAEL value of 800 mg/kg bw/day was concluded. No histopathological changes were observed in any reproductive organ neither in male nor in female animals up to the highest dose tested. Therefore, according to Column 1, Section 8.7.3, Annex IX of REACH Regulation an extended one-generation study is not proposed also due to animal welfare reasons.


Effects on developmental toxicity

Effect on developmental toxicity: via oral route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available

Justification for classification or non-classification

There are no data available for development and teratogenicity. However, a study according OECD TG 414 is planned and a testing proposal is included.

Additional information