Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Endpoint summary
Administrative data
Description of key information
Guidelines
The study was based on the following guidelines.
- EC Directive 96/54/EEC, B.7 Repeated Dose (28 days) Toxicity (oral), 1996.
- OECD 407, Repeated Dose 28-day Oral Toxicity Study in Rodents, 1995.
- OPPTS 870.3050, Repeated dose 28-day oral toxicity study in rodents. Office of Prevention, Pesticides and Toxic Substances (7101), EPA 712-C-00-366, 2000.
Rationale for dose levels
Based on the results of a 5-day range finding study, the dose levels for this 28-day oral gavage study were selected to be 0, 50, 150 and 1000 mg/kg/day.
Study outline
The test substance was administered daily for 31 days by oral gavage to SPF-bred Wistar rats. One control group and three treated groups were tested, each consisting of 5 males and 5 females.
Evaluated parameters
Chemical analyses of formulations were conducted once during the study to assess accuracy and homogeneity.
The following parameters were evaluated: clinical signs daily; functional observation tests in week 4; body weight and food consumption weekly; clinical pathology and macroscopy at termination; organ weights and histopathology on a selection of tissues.
Results
Formulation analyses confirmed that formulations of test substance were prepared accurately and homogenously.
No treatment-related toxicologically significant changes were noted in any of the parameters investigated in this study (i.e. clinical appearance, functional observations, body weight, food consumption, clinical laboratory investigations, macroscopic examination, organ weights, and microscopic examination).
From the results presented in this report a definitive No Observed Adverse Effect Level
(NOAEL) for the test substance of 1000 mg/kg/day was established
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- High quality
Additional information
Justification for classification or non-classification
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.
