Registration Dossier
Registration Dossier
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EC number: 235-397-1 | CAS number: 12217-38-8
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:
- weight of evidence
- Study period:
- 1979
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- The test was conducted by means of Read Across approach. No information on test substance composition is available. Further information was attached at section 13
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
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:
- yes
Test material
- Reference substance name:
- Acid Yellow 061 - Similar Substance 01
- IUPAC Name:
- Acid Yellow 061 - Similar Substance 01
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- Stamm Wistar TNO W 74
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Winkelmann, Borchen
- Age at study initiation: 9 to 14 weeks old
- Weight at study initiation: average initial weight of 180 g
- Housing: Makrolon cage type III
- Diet (e.g. ad libitum): Altromin R 1324 ad libitum
- Water (e.g. ad libitum): ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 1.5 °C
- Humidity (%): 60 ± 5 %
- Photoperiod (hrs dark / hrs light): artificial lighting from 7 a.m. to 7 p.m.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- Volume applied: 30ml/kg bw
- Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 5 per sex per dose
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: twice daily and once on weekends and holidays
- Other examinations performed: clinical signs, body weight
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP criteria not met
- Conclusions:
- LD50 > 5000 mg/kg bw
- Executive summary:
The substance was tested according to a method similar to the OECD guideline 401. 5 males and 5 females were administered at a dose of 5000 mg/kg bw and observed for 14 days.
No relevant clinical signs were observed in none of the animal tested. The LD50 was then greater than 5000 mg/kg bw.
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