Registration Dossier
Registration Dossier
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EC number: 412-570-1 | CAS number: 119462-56-5
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Additional information
The reproductive toxicity of PERKALINK 900 was studied in a GLP-compliant OECD 416 guideline study in which male and female rats received 0, 800, 1600 and 3200 mg/kg diet in an oral feeding study. Animals were exposed during the premating period of at least 10 weeks, during mating, gestation and lactation until sacrifice over two successive generations. The NOAEL for parental toxicity was 800 mg/kg diet (57.4 and 70.7 mg/kg bw/day for males and females, respectively) based on decreased body weight and reduced food consumption.
There were no treatment related effects in males for reproductive toxicity, therefore the NOAEL 3200 mg/kg diet (236.7 mg/kg bw/day), the highest dose tested. In females decreased absolute and relative weight of the uterus and ovaries and histopathological changes in the ovaries, uterus and vagina were observed, resulting in a NOAEL of 1600 mg/kg diet (139.2 mg/kg bw/day).
The NOAEL for developmental toxicity was 800 mg/kg diet (57.4 and 70.7 mg/kg bw/day for males and females, respectively) based on decreased pup weight and decreased spleen weight in the pups. These effects on pups were considered to be secondary effects due to reduced maternal body weight and food intake.
Short description of key information:
The available data do not indicate that PERKALINK 900 causes effects on fertility.
Effects on developmental toxicity
Description of key information
The available data do not indicate that PERKALINK 900 causes developmental toxicity.
Additional information
The developmental toxicity of PERKALINK 900 was studied in a GLP-compliant OECD 414 guideline study in which female rats received 0, 800, 1600 and 3200 mg/kg diet in an oral feeding study. Animals were exposed from GD 0-21. The NOAEL for maternal toxicity was 1600 mg/kg diet (105 mg/kg bw/day) based on statistically significant effects on body weight, body weight change, food consumption, carcass weight and net weight change.
Since no effects were observed on fertility, reproductive performance, reproductive organ weights, litter data, fetal external, visceral, and skeletal examinations, the NOAEL 3200 mg/kg diet (196 mg/kg bw/day), the highest dose tested.
Justification for classification or non-classification
In accordance with Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008, classification is not necessary for effects on fertility and developmental toxicity.
Additional information
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