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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

No treatment-related effects on female fertility were seen in the developmental toxicity study. In addition, no treatment-related malformationwere seen in the offspring in this study. The maternal and developmental NOAELs were determined to be >2000 mg/kg bw/day.

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

Effects on developmental toxicity

Description of key information

No treatment-related effects were seen in the developmental toxicity study. The maternal and developmental NOAELs were determined to be >2000 mg/kg bw/day.

Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
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

A study was conducted to determine the developmental toxicity of the test substance (99.61% purity) in rat. Female Sprague Dawley rats (25/dose) were administered by gavage the following concentrations (dissolved corn oil, at a volume of 10 mL/kg bw): 0, 500, 1000 and 2000 mg/kg bw/day from gestational day (GD) 6 to 15. The homogeneity, stability and concentrations of dosing suspensions were analysed and were within acceptable values. Clinical signs were recorded daily and twice daily during the dosing period. Maternal body weight were measured on GD 0, 6, 9, 12, 15, 18 and 20 and food consumption on GD 0-6, 6-9, 9-12, 12-15, 15-18 and 18-20. At scheduled sacrifice on GD 20, the dams were evaluated for body weight, liver and gravid uterine weight. Ovarian corpora lutea were counted and the status of uterine implantation sites (i.e., resorptions, dead fetuses, live fetuses, pre and post-implantations) was recorded. Fetuses were dissected from the uterus, counted, weighted, sexed and examined for external abnormalities as well as for visceral malformations and variations. Sections of the heads were examined for soft tissue craniofacial malformations and variations. All fetuses were eviscerated, fixed in alcohol, and stained with alizarin red S/alcian blue. Intact fetuses were examined for skeletal malformations and variations. Except for green, dark and/or green feces at 500 mg/kg bw/day and above, piloerection at all concentrations (GD 12-20) and vaginal bleeding at 2000 mg/kg bw/day in one dam on GD 15, no other effects were observed. Gestational parameters (e.g. ovarian corpora lutea, uterine implantation sites, resorptions, dead fetuses, live fetuses, pre and post-implantation losses) were not modified by the treatment. Two litters at 500 mg/kg bw/day were fully resorbed; all remaining pregnant animals had one or more live fetuses on GD 20. Fetal body weight was slightly reduced at 2000 mg/kg bw/day with no obvious dose-related trends. Malformations (external and skeletal) were recorded but with no treatment-related patterns of incidence or severity. Under the study conditions, the maternal and developmental NOAELs were determined to be >2000 mg/kg bw/day.

Justification for classification or non-classification

Based on the results of the pre-natal developmental toxicity studies in rats and rabbits, no classification for this endpoint is required according to CLP (EC 1272/2008) criteria.​

Additional information