Registration Dossier
Registration Dossier
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EC number: 485-390-4 | CAS number: -
Endpoint summary
Administrative data
Description of key information
In a GLP-study according to OECD test guideline 423, the LD50 (oral) of the registered substance was determined as > 2000 mg/kg bw.
In a GLP-study according to OECD test guideline 402, the dermal LD50 of the registered substance was determined as > 2000 mg/kg bw.
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Acute toxicity: via dermal route
Endpoint conclusion
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Additional information
For the registered substance, one acute oral study was available. As this study was conducted under GLP-conditions according to an OECD test guideline it was considered as Klimisch 1.
The acute oral toxicity in rats was determined according to the method recommended in the OECD Guideline No. 423, "Acute Oral Toxicity — Acute Toxic Class Method", December 2001. The study was carried out with two groups consisting of three female animals each given a dose of 2000 mg/kg b.w. respectively. All animals in the study survived the treatment and showed only slight signs of toxicosis. Under the experimental conditions described in this final report, the oral LD50 of the registered substance in rats was found to be above 2000 mg/ kg b.w. (Cognis, 2006).
For the registered substance, one acute dermal study was available. As this study was conducted under GLP-conditions according to an OECD test guideline it was considered as Klimisch 1.
The acute dermal toxicity of the registered substance was investigated in a GLP-study according to OECD test guideline 402. Two groups (control and treatment with 2000 mg/kg bw)) of 5 males and 5 females were used. About 10% of the body surface was clipped 24 hour prior to treatment. The rats were observed for 14 days and subsequently sacrificed and subjected to gross pathology. As no toxicological effects were observed (mortality, body weigt, behaviour and gross pathology), the dermal LD50 of the registered substance was determined as > 2000 mg/kg bw. (Cognis, 2006).
No acute inhalation study was available for the registered substance. As exposure of humans via the inhalative route is unlikely, especially because of the low vapour pressure (0.168 Pa), testing of the inhalative route is - according to REACH Annex VIII (8.5.2) - not appropriate.
Justification for classification or non-classification
Based on the results of the acute toxicity studies, the test item is not subjected to classification and labelling for acute toxic effects according to Directive 67/548/EEC (DSD) and Regulation (EC) No 1272/2008 (GHS/CLP).
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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