Registration Dossier
Registration Dossier
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EC number: 279-919-6 | CAS number: 82205-20-7
Endpoint summary
Administrative data
Description of key information
No data is available for the target substance. Thus, available data from the structural analogue (chloride salt) of the target substance was used in a read-across approach. Details on the read-across rational are provided in section 13. The source substance was tested in a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test (OECD 422). No adverse effects were found after oral administration of the test item in male and female rats. Based on the results, the NOAEL is considered to be 250 mg/kg bw/day.
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
- 250 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- GLP guideline study
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
No data is available for the target substance. Thus, available data from the structural analogue (chloride salt) of the target substance was used in a read-across approach. Details on the read-across rational are provided in section 13.
The source substance was tested in a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test (OECD 422) at dose levels of 0, 40, 100 and 250 mg/kg bw/day. No adverse effects of the test item were found up to the dose level of 250 mg/kg body weight/day. No mortality occurred in the control or in any of the dose groups during the treatment period of this study. There were no clinical signs of toxicological relevance in the dose groups when compared to the control group. The neurotoxicity assessment (motor activity, grip strength and sensory activity) did not reveal any changes attributable to the test item. There were changes of minimal severity in body weight and body weight gain in both male and female animals which were considered irrelevant. There were no adverse effects on food consumption of males and females of the dosing groups compared to control animals during the study period. Furthermore, no adverse changes were measured for haematology and clinical chemistry parameters. Additionally, no adverse effects were seen in gross and histopathology when compared with controls. The NOAEL in this study is considered to be 250 mg/kg bw/day.
Justification for classification or non-classification
Based on the available data from a suitable read-across partner, the target substance does not warrant classification for specific target organ toxicity in accordance to CLP regulation (EC) No 1272/2008.
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.
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