Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Description of key information

Key value for chemical safety assessment

Justification for classification or non-classification

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 carcinogenicity.

Additional information

No valid data on carcinogenicity studies in vitro is available.

Only one in vivo study for long-term toxicity of N-(cyclohexylthio)phtalimide in animals provided by U. S. EPA is available. Due to the lack of progression from benign to malignant lesions, the lack of proliferative lesions in males and negative results in genetic toxicology studies, the benign liver tumors were not considered to pose a significant human health risk. The NOAELs were 500 mg/kg/day for males, 500 mg/kg/day for females for malignant tumors and 50 mg/kg/day for females for benign tumors. The LOAEL was not determined for males and it was 150 mg/kg/day for benign tumors in females.