Registration Dossier
Registration Dossier
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EC number: 202-803-3 | CAS number: 99-94-5
Endpoint summary
Administrative data
Description of key information
Although the intraperitoneal injection studies in the rat returned results of LD50 male 944 mg/kg bw and female 874 mg/kg bw, which implies a classification of Acute Toxicity 4, they will not be used for classifcation as this is not an accepted route for human exposure.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- not specified
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male/female
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Doses:
- 0(vehicle), 1000, 1500, 2000 mg/kg bw
- No. of animals per sex per dose:
- Five males and five females were assigned to each dose.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No deaths occurred during the study.
- Clinical signs:
- other: One female was observed with temporary loose stool at 2000 mg/kg bw. No clinical signs were observed in the animals given 1000 and 1500 mg/kg bw.
- Gross pathology:
- No macroscopic abnormalities were observed at autopsy for any doses in either sex.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The result of acute oral toxicity LD50 >2000 mg/kg bw results in a not classified verdict.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- Klimisch 1
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
Justification for classification or non-classification
Although the intraperitoneal injection studies in the rat returned results of LD50 male 944 mg/kg bw and female 874 mg/kg bw, which implies a classification of Acute Toxicity 4, they will not be used for classifcation as this is not an accepted route for human exposure.
This substance is not classified for acute toxicity.
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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