Registration Dossier
Registration Dossier
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EC number: 201-781-2 | CAS number: 87-89-8
Endpoint summary
Administrative data
Description of key information
Oral: QSAR predicted value; rat LC50: 194843.68 mg/kg. Reliability = 2
Inhalation: No study available
Dermal: No study available
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- (Q)SAR
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- results derived from a valid (Q)SAR model and falling into its applicability domain, with adequate and reliable documentation / justification
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Consensus model in Test v4.2.1
Model prediction report is attached in IUCLID - GLP compliance:
- no
- Test type:
- other: QSAR predicition
- Species:
- rat
- Key result
- Dose descriptor:
- LD50
- Effect level:
- 19 483.68 mg/kg bw
- Remarks on result:
- other: QSAR predicted value
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- LD50 (rat): 19483.68 mg/kg
- Executive summary:
The consensus model in Times v4.2 was used to predict the acute toxicity to rats. The oral LD50 in rats was predicted to be 19483.68 mg/kg. Additional supporting documentation is provided in the prediction report attached in IUCLID.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 19 483.68 mg/kg bw
- Quality of whole database:
- QSAR predicted value
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
The consensus model in Times v4.2 was used to predict an oral LD50 in rats of 19483.68 mg/kg. Data found in the RTECS database (LD50 in mice >10000 mg/kg), as well as a review of 12 controlled clinical trials where total of 250 adults were given oral doses equal to 67 and 500 mg/kg/day over 1 to 12 months that did not report any mortality, support the low toxicity potential of the test substance via the acute oral route.
Justification for classification or non-classification
Based on the predicted oral LD50 in rats of 19483.68 mg/kg and supporting mouse and human data, no classification is required for the acute oral 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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