Registration Dossier
Registration Dossier
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EC number: 942-403-2 | CAS number: -
Endpoint summary
Administrative data
Description of key information
No acute toxicity studies are available on the substance. However, in a 90-day repeated dose toxicity study, no mortality occurred in rats treated by oral gavage up to the highest dose tested, i.e. 1000 mg/kg bw/day, and the NOAEL identified in this study was 1000 mg/kg bw/day.
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
According to the methodology described by Bulgheroni et al., 2009, non toxic compounds (LD50>2000 mg/kg bw) could be identified with NOAEL value from 28-day repeated dose toxicity studies. The NOAEL threshold ≥ 200 mg/kg bw/day could identify 63% of non toxic compounds. The registered substance fully complies with those criteria as a NOAEL of 1000 mg/kg bw/day was obtained in a 90-day repeated dose toxicity study (higher NOAEL in a longer study). Also, in this recent 90-day repeated dose toxicity study, no mortality occurred in rats treated by oral gavage up to the highest dose tested, i.e. 1000 mg/kg bw/day, for 90 consecutive days. Based on these elements, the registered substance is expected to have very low acute toxicity (LD50>2000 mg/kg bw) and the conduction of in vivo acute oral and dermal toxicity studies are therefore not deemed necessary.
Justification for classification or non-classification
According to the methodology described by Bulgheroni et al., 2009, non toxic compounds (LD50>2000 mg/kg bw) could be identified with NOAEL value from 28-day repeated dose toxicity studies. The NOAEL threshold ≥ 200 mg/kg bw/day could identify 63% of non toxic compounds. The registered substance fully complies with those criteria as a NOAEL of 1000 mg/kg bw/day was obtained in a 90-day repeated dose toxicity study (higher NOAEL in a longer study). Also, in this recent 90-day repeated dose toxicity study, no mortality occurred in rats treated by oral gavage up to the highest dose tested, i.e. 1000 mg/kg bw/day, for 90 consecutive days. Based on these elements, the registered substance is expected to have very low acute toxicity (LD50>2000 mg/kg bw) and it is considered that it does not require any classification for acute toxicity according to CLP regulation (EC) n°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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