Registration Dossier
Registration Dossier
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EC number: 286-839-5 | CAS number: 85391-83-9
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1974
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 974
- Report date:
- 1974
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- 7-[(5-chloro-2,6-difluoro-4-pyrimidinyl)amino]-4-hydroxy-3-[(4-methoxy-2-sulphophenyl)azo]naphthalene-2-sulphonic acid, sodium salt
- EC Number:
- 286-839-5
- EC Name:
- 7-[(5-chloro-2,6-difluoro-4-pyrimidinyl)amino]-4-hydroxy-3-[(4-methoxy-2-sulphophenyl)azo]naphthalene-2-sulphonic acid, sodium salt
- Cas Number:
- 85391-83-9
- Molecular formula:
- C21H14ClF2N5O8S2.xNa
- IUPAC Name:
- 7-[(5-chloro-2,6-difluoro-4-pyrimidinyl)amino]-4-hydroxy-3-[(4-methoxy-2-sulphophenyl)azo]naphthalene-2-sulphonic acid, sodium salt
- Test material form:
- solid
- Details on test material:
- Reactive Red 123
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- peanut oil
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 20 - 30 mL/kg bw
- Doses:
- 5, 6, 7, 8 and 9 g/kg bw
- No. of animals per sex per dose:
- 10
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Statistics:
- Probit analysis
Results and discussion
Effect levelsopen allclose all
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- ca. 4 776 mg/kg bw
- Based on:
- act. ingr.
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 7 024 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 6 478 - 7 568
- Mortality:
- mortality 3 hours to 3 days after application
- Clinical signs:
- uncoordinated movements, abdominal position, sedation
Any other information on results incl. tables
dose [g/kg bw] |
mortality [dead/tested animals] |
| 5 | 0/10 |
| 6 | 2/10 |
| 7 | 5/10 |
| 8 | 7/10 |
| 9 | 10/10 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LD50 to female rats (oral, gavage) was determined to be 4773 mg/kg bw (act. ingr.). The substance is not classifiable according to CLP criteria.
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