Registration Dossier
Registration Dossier
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EC number: 424-250-9 | CAS number: -
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Yellow MGi 1301
- IUPAC Name:
- Yellow MGi 1301
- Test material form:
- solid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: HanIbm: WIST (SPF)
- Sex:
- male/female
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- water
- Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Details on study design:
- The test article was suspended in vehicle (bidistilled water) at a concentration of 0.5 g/rnl and administered at a volume of 4 ml/kg. The animals were examined for clinical signs four times during day I and once daily during days 2 -15. Mortality/viability were recorded together with clinical signs at the same time intervals.
Body weights were recorded on day 1 prior to administration and on days 8 and 15. All animals were necropsied and examined macroscopically.
Results and discussion
Effect levels
- 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:
- No clinical signs of systemic toxicity were observed during the observation period. Local effects of the test article on the skin at the application site such as an orange discoloration in all animals and scales on the back in one male animal were observed during the observation period.
- Body weight:
- The body weight of the animals was within the range of physiological variability known for rats of this strain and age.
- Gross pathology:
- No macroscopic organ findings were observed at necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified within the CLP Regulation (EC 1272/2008)
- Conclusions:
- LD50 > 2000 mg/kg bw
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