Registration Dossier
Registration Dossier
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EC number: 260-906-9 | CAS number: 57693-14-8
Endpoint summary
Administrative data
Description of key information
In a study according to OECD guideline 422, no adverse effects at all were observed in parental as well as in offspring animals. The NOAEL regarding systemic toxicity was 1000 mg/kg/day.
Key value for chemical safety assessment
- Toxic effect type:
- dose-dependent
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
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
Although the available oral study in rats according to OECD guideline 422 showed clear bioavalability of test substance, the substance did not cause any adverse effects in treated rats up to and including a dose level of 1000 mg/kg bw daily. The NOAEL was set at 1000 mg/kg bw/day.
Justification for classification or non-classification
According to the CLP Regulation (EC 1272/2008):
- classification in Category 1 is applicable, when significant toxic effects observed in a 90-day repeated-dose study conducted in experimental animals are seen to occur at or below the guidance values 10 mg/kg bw/d by oral route;
- classification in Category 2 is applicable, when significant toxic effects observed in a 90-day repeated-dose study conducted in experimental animals are seen to occur within 10 and 100 mg/kg bw/day by oral route.
The guidance values refer to effects seen in a standard 90-day toxicity study conducted in rats. They can be used as a basis to extrapolate equivalent guidance values for toxicity studies of greater or lesser duration, using dose/exposure time extrapolation similar to Haber's rule for inhalation, which states essentially that the effective dose is directly proportional to the exposure concentration and the duration of exposure. The assessment shall be done on a case-by- case basis; for a 28-day study the guidance values are increased by a factor of three.
Based on a study duration of at least 28 days, threshold values become 30 mg/kg bw/day for category 1 and 30 -300 mg/kg bw/day for category 2.
Based on a NOAEL of 1000 mg/kg bw/day for systemic toxicity, no classification applies.
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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