Registration Dossier
Registration Dossier
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EC number: 464-520-3 | CAS number: 189813-45-4
Endpoint summary
Administrative data
Description of key information
The test substance does not require any classification for oral and dermal route according to EU or GHS standards.
LD50 (oral and dermal), rats: >2000 mg/kg bw
Key value for chemical safety assessment
Additional information
Acute oral:
In the key study (BASF AG, 2000) performed according to OECD guideline 423 (Acute oral toxicity- Acute toxic class method) and GLP, a group of six fasted animals (three males and three females) were treated with a single oral dose of the test material preparation in olive oil at a dose level of 2000 mg/kg bw. Signs of toxicity noted in the female animals were impaired general state, dyspnoea, staggering, ataxia, spastic gait and shaking. The animals appeared normal within 5 days after application. The male rats did not show any symptoms. The expected body weight gain was observed in the course of the study. No mortality occurred and no abnormalities were noted at necropsy of animals sacrificed at the end of the study. Based on the results, the LD50 was found to be greater than 2000 mg/kg bw for the male and female animals.
Acute dermal:
In the key study (BASF AG, 2006) performed according to OECD guideline 402 (Acute dermal toxicity) and GLP, a single dose of 2000 mg/kg bw of the test material preparation in olive oil was applied in five male and five female animals to the clipped skin (dorsal and dorsolateral parts of the trunk) and covered by a semi-occlusive dressing for 24 hours. No mortality occurred and no systemic clinical observations or skin effects were noted in the animals. The mean body weights of the animals increased throughout the study period. No macroscopic pathologic abnormalities were noted in the animals examined at the end of the study. Based on the results, the LD50 was found to be greater than 2000 mg/kg bw for the male and female animals.
Acute Inhalation: no data
Combining all animal data, the test substance does not require any classification for oral and dermal route according to EU or GHS standards.
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.
