Registration Dossier
Registration Dossier
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EC number: 807-008-0 | CAS number: 1173693-36-1
Endpoint summary
Administrative data
Description of key information
Oral: OECD 425; rat LD50: 3129 mg/kg. Reliability = 1
Dermal: OECD 402; rat LD50: >5000 mg/kg. Reliability = 1
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 3 129 mg/kg bw
- Quality of whole database:
- GLP, guideline study
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
- Quality of whole database:
- GLP, guideline study
Additional information
The substance was evaluated for acute toxicity (lethality) via the acute oral and dermal routes of exposure. A single dose of the test substance was administered by oral gavage to fasted female rats at a dose of 175, 550, 1750, or 5000 mg/kg. The oral LD50 for the test substance was 3129 mg/kg for female rats. All rats at 5000 mg/kg were moribund and sacrificed for human reasons. No other mortality was observed. Clinical signs in surviving rats included ataxia, decreased muscle tone, high posture, low posture, splayed forelimbs and hindlimbs, and/or eyelid ptosis. No body weight losses occurred in surviving rats and no test substance-related gross lesions were found in the study.
A single dose of the test substance was applied to the shaed intact skin of male and female rats at a dose of 5000 mg/kg. The male and female rat dermal LD50 was greater than 5000 mg/kg. Although one rat was found dead the day after application, the cause of death was not determined. Two rats experienced body weight loss on test day 7, but gained weight by test day 14. No other body weight losses, clinical signs of toxicity, dermal irritation, or test substance related gross lesions were observed.
Justification for classification or non-classification
Based on oral and dermal LD50s in rats of 3129 mg/kg and >5000 mg/kg, respectively, no classification is required for acute oral or dermal toxicity endpoints according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
The registrant believes that conducting an acute inhalation LC50 study with the test material is not feasible based upon the physical and chemical properties of the test substance. Therefore, no inhalation study was performed and since the test substance would not be respirable, no classification is required for acute inhalation toxicity endpoint according to EU Classification, Labelling and Packaging of Substances and Mixtures (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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