Registration Dossier
Registration Dossier
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EC number: 241-774-1 | CAS number: 17796-82-6
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Additional information
In the original study provided by the Registrant no adverse effects were observed, hence, no NOAEL was determined (Biological Department Hameln rds, a.s. 11 November 2009).
Therefore the U.S. EPA data onreproduction toxicityof N-(cyclohexylthio)phtalimide were used as the key information source for further assessment.
In one generation study of toxicity to reproduction with oral application,no consistent reproductive effectsofN-(cyclohexylthio)phtalimidewere noted.The NOEL (parental) was 150 mg/kg bw for both sexes, the NOEL (F1offspring) was 50 mg/kg bw for males and 150 mg/kg bw for females[all based on body weight]. The NOEL (F2offspring) was 150 mg/kg bw [based on 24-hour survival index](Monsanto BD-77-356, Bio/Dynamics, Inc., 1979).
In study performed in accordance with the U.S. EPA TSCA Guidelines for Teratogenicity Study, administration ofN-(cyclohexylthio)phtalimideby gastric intubation to pregnant New Zealand White rabbits was not considered maternally toxic, embryotoxic, foetotoxic or teratogenic. At 100 mg/kg/day, maternal toxic effects and foetotoxic effects were seen. The test compound was not considered to be teratogenic at any of the dose levels evaluated.The NOEL (maternal) was 30 mg/kg/day [based on weight loss] and theNOEL (teratogenicity) was 100 mg/kg/day(Monsanto BD-83-162, Bio/dynamics Inc., 1985).
Effects on developmental toxicity
Additional information
In the original study provided by the Registrant no adverse effects were observed, hence, no NOAEL was determined (Biological Department Hameln rds, a.s. 11 November 2009).
Therefore the U.S. EPA data onreproduction toxicityof N-(cyclohexylthio)phtalimide were used as the key information source for further assessment.
In one generation study of toxicity to reproduction with oral application,no consistent reproductive effectsofN-(cyclohexylthio)phtalimidewere noted.The NOEL (parental) was 150 mg/kg bw for both sexes, the NOEL (F1offspring) was 50 mg/kg bw for males and 150 mg/kg bw for females[all based on body weight]. The NOEL (F2offspring) was 150 mg/kg bw [based on 24-hour survival index](Monsanto BD-77-356, Bio/Dynamics, Inc., 1979).
In study performed in accordance with the U.S. EPA TSCA Guidelines for Teratogenicity Study, administration ofN-(cyclohexylthio)phtalimideby gastric intubation to pregnant New Zealand White rabbits was not considered maternally toxic, embryotoxic, foetotoxic or teratogenic. At 100 mg/kg/day, maternal toxic effects and foetotoxic effects were seen. The test compound was not considered to be teratogenic at any of the dose levels evaluated.The NOEL (maternal) was 30 mg/kg/day [based on weight loss] and theNOEL (teratogenicity) was 100 mg/kg/day(Monsanto BD-83-162, Bio/dynamics Inc., 1985).
Justification for classification or non-classification
Based on the test results and according to the EC criteria for classification and labelling requirements for dangerous substances and mixtures the test substance does not have to be classified for toxicity to reproduction.
Additional information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
