Registration Dossier
Registration Dossier
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EC number: 946-366-3 | CAS number: -
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study has been presented to ECHA in the framework of a NONS notification. The document is now public because presented more than 12 years ago. The summary received is from migrated NONS dossier
Data source
Reference
- Reference Type:
- other: body responsible for the test
- Title:
- Unnamed
- Year:
- 1 997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Reactive Orange 011:1 - Similar Substance 02
- IUPAC Name:
- Reactive Orange 011:1 - Similar Substance 02
- Test material form:
- not specified
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
Administration / exposure
- Vehicle:
- other: distilled water
- No. of animals per sex per dose:
- 5 males and 5 females
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
- Clinical signs:
- No signs of toxicity for females. For males orange feces were observed at day 2 and 3.
- Body weight:
- One female showed a decrease in the body weight during the second week of the test
- Gross pathology:
- No effects on the organs
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP criteria not met
- Conclusions:
- LD50 > 2000 mg/kg kw.
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