Registration Dossier
Registration Dossier
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EC number: 641-136-6 | CAS number: 1160164-88-4
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Additional information
Short description of key information:
Reproductive Toxicity: Testing proposed
Effects on developmental toxicity
Description of key information
Developmental Toxicity: An OECD 414 (prenatal developmental toxicity study) compliant GLP study was conducted in rats to assess the developmental\l toxicity of alcohols, C18-22, distillation residues (CAS No. 1160164-88-4). At dose levels up to 1000mg/kg no obvious effects on pregnancy, embryotoxicity or foetal toxicity were noted. The maternal and foetal no observed effect level (NOEL) were both considered to be 1000 mg/kg/day.
Additional information
Developmental Toxicity:
A reliable (Klimisch 1) OECD 414 (prenatal developmental toxicity study) compliant GLP study was conducted in rats to assess the developmental\l toxicity of alcohols, C18-22, distillation residues (CAS No. 1160164-88-4). Mated female Sprague Dawley rats were randomised into 3 test groups and a control group, each containing 24 animals. The animals were dosed by oral gavage over Days 6 -19 inclusive of gestation, where the day of detection of mating was designated Day 0. Dose levels administered were 0, 100, 300 and 1000 mg/kg/day.
The study animals were regularly monitored during gestation period for clinical signs of toxicity. Bodyweight and food consumption was also monitored. Termination of the animals occurred on ay 20 and the status of each implantation was recorded. Foetuses were weighed and examined for visceral and skeletal abnormalities, including the state of skeletal ossification.
At the top dose level of 1000 mg/kg, alcohols, C18-22, distillation residues did not appear to have any obvious effects on body weight gain or food consumption. No clinical signs of toxicity were reported. The incidence of embryo-foetal deaths and mean foetal weights did not suggest any obvious effect of treatment. In addition the type and distribution of foetal abnormalities and variants did not suggest any obvious effect of treatment. Under the conditions of this study, the maternal and foetal no observed effect level (NOEL) were both considered to be 1000 mg/kg/day.
Justification for classification or non-classification
Additional information
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