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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Description of key information

Data obtained from a 28-day toxicity study in Wistar rats (OECD407) shows that the test substance has no effect on the estrous cycle and on the sperm parameters and no macroscopical and microscopical effects on the reproductive organs were observed. This study is considered to give sufficient information to permit the conclusion that the substance is not toxic to reproduction.

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
subacute
Species:
rat
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

Short description of the available data:
With regard to fertility, no effect on the estrous cycle and on the sperm parameters and no macroscopical and microscopical effects on the reproductive organs were observed in a 28d study (BASF 2013). In further subacute or subchronic studies with close homologues, no indication for a reproduction toxic potential was observed either.

According to item 8.7.2 in Column 1 of Annex IX of REACH (Regulation No 1907/2006), a 2-generation or extended one generation study is regarded a standard data requirement. In the ECHA Guidance on information requirements and chemical safety assessment; Chapter R.7a R7.6.6 a testing strategy for reproductive toxicity is described. It is stated that all substances needs to be subject to a thorough data review and that if sufficient data are available to permit a conclusion on reproductive and developmental toxicity potential, no further testing is required. The information given is considered to be sufficient to permit the conclusion that the substance is not toxic to reproduction. Therefore, further testing for reproductive toxicity is considered not justified, taking into account animal welfare aspects.

Effects on developmental toxicity

Description of key information

In a prenatal developmental toxicity study (OECD 414, GLP) the test substance was administered to pregnant Wistar rats daily by gavage from implantation to one day prior to the expected day of parturition (GD 6-19) at concentrations of 100, 300 and 1000 mg/kg bw. There was no evidence for toxicologically relevant adverse effects of the test substance on dams or pub development. The no observed adverse effect level (NOAEL) for maternal and prenatal developmental toxicity is 1000 mg/kg bw/d.

Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
subacute
Species:
rat
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

In a prenatal developmental toxicity study, in accordance with GLP and OECD 414, the test substance was administered to pregnant Wistar rats daily by gavage from implantation to one day prior to the expected day of parturition (GD 6-19) to evaluate its potential maternal and prenatal developmental toxicity. Analyses confirmed the correctness of the prepared concentrations and the stability of the test substance in the vehicle. Generally, clinical observations including water consumption, food consumption and body weight gain revealed no toxicologically relevant difference between the animals receiving 100, 300 or 1000 mg/kg bw/d and controls. Most of the females (18 out of 25) of the high-dose group (1000 mg/kg bw/d) and one female of the mid-dose group (300 mg/kg bw/d) showed transient salivation during the treatment period. Salivation occurred in the respective animals only within the 2-hour examination interval (i.e. < 2h after treatment). It is considered to be treatment-related, likely as a result of the bad taste of the test substance/vehicle preparation or due to local irritation of the upper digestive tract. It is not considered to be a sign of systemic toxicity. No differences of toxicological relevance between the control and the treated groups (100, 300 or 1000 mg/kg bw/d) were determined for any reproductive parameters, such as conception rate, mean number of corpora lutea, mean number of implantations, as well as pre- and postimplantation loss. Similarly, no influence of the test substance on fetal weight and sex distribution of the fetuses was noted at any dose. Overall, there was no evidence for toxicologically relevant adverse effects of the test substance on fetal morphology at any dose. Under the conditions of this prenatal developmental toxicity study, the oral administration to pregnant Wistar rats from implantation to one day prior to the expected day of parturition (GD 6-19) at doses as high as 1000 mg/kg bw/d caused neither evidence of maternal nor developmental toxicity. In conclusion, the no observed adverse effect level (NOAEL) for maternal and prenatal developmental toxicity is 1000 mg/kg bw/d (BASF 2016)

Justification for classification or non-classification

Based on the available data classification for reproductive/ developmental toxicity is not warranted in accordance with EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation No. 1272/2008.

Additional information