Registration Dossier

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
Short description of key information:
No adverse findings on reproductive organs were observed in the 90-day gavage study with doses of 100, 300 and 1000 mg/kg bw. (OECD 408, GLP,BASF 2014).

Effects on developmental toxicity

Description of key information
No indication of developmental toxicity or teratogenicity was observed in rats at doses of 100, 300 and 1000 mg/kg bw (GLP, OECD 414).
Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
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

The substance was tested for its prenatal developmental toxicity in Wistar rats in a GLP compliant study according to OECD testing guideline 414. T The test substance was administered as an aqueous suspension to groups of 25 time-mated female Wistar rats by gavage at doses of 100, 300, and 1000 mg/kg body weight/day (mg/kg bw/d) on gestation days (GD) 6 through 19. The control group, consisting of 25 females, was dosed with the vehicle (1% Carboxymethylcellulose suspension in drinking water (1% CMC)) in parallel. A standard dose volume of 10 mL/kg body weight was used for each test group.

At terminal sacrifice on GD 20, 25 females per group had implantation sites.

Food consumption and body weights of the animals were recorded regularly throughout the study period. The state of health of the animals was checked each day. On GD 20, all females were sacrificed by cervical dislocation (under isoflurane anesthesia) and assessed by gross pathology (including weight determinations of the unopened uterus and the placentae). For each dam, corpora lutea were counted and number and distribution of implantation sites (differentiated between resorptions, live and dead fetuses) were determined. The fetuses were removed from the uterus, sexed, weighed and further investigated for external findings. Thereafter, one half of the fetuses of each litter were examined for soft tissue findings and the remaining fetuses for skeletal (inclusive cartilage) findings.

The stability of the test substance preparations was demonstrated over a period of 7 days in a refrigerator and the correctness of the prepared concentrations was shown.

Statistically significantly increased fetal skeletal variations consisted of incomplete ossification of cervical and sacral arch (cartilage present) and unilateral ossification of sternebra (unchanged cartilage). All these minor changes may be indicative for a minimal delay of skeletal maturation, however, the slightness of these apparent effects made it difficult to judge whether these are real effects or not. They are in any case not considered as adverse events.

The no observed adverse effect level (NOAEL) for maternal and prenatal/ developmental toxicity is 1000 mg/kg bw/d.

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available developmental toxicity study (OECD 414) is considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is not considered to be classified for developmental toxicity under Directive 67/548/EEC, as amended for the 31st time in Directive 2009/2/EG. 

No indications of toxicity to reproductive organs were noted upon subchronic exposure, therefore no classification is needed for fertility.

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008

The available developmental toxicity study (OECD 414) is reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for developmental toxicity under Regulation (EC) No. 1272/2008, as amended for the fifth time in Directive EC944/2013.

No indications of toxicity to reproductive organs were noted upon subchronic exposure, therefore no classification is needed for fertility.