Registration Dossier
Registration Dossier
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EC number: 224-115-2 | CAS number: 4203-77-4
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- March 13, 1975
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- The study has been conducted according to procedures similar to the accepted guidelines but the content of the active ingredient in the substance composition is very low.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 975
- Report date:
- 1975
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:
- Vat Red 013
- IUPAC Name:
- Vat Red 013
- Test material form:
- not specified
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Tif. RAI
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: CIBA breeding unit
- Age at study initiation: 6 to 7 weeks old
- Weight at study initiation: 160 to 180 g
- Fasting period before study: one night before starting the treatment
- Housing: housed in Macrolon cages (Type 3) in groups of 5
- Diet (e.g. ad libitum): NAFAG, Gossau SG, rat food ad libitum
- Water (e.g. ad libitum): ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1 °C
- Humidity (%): approx. 50 %
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 50 % in vehicle - Doses:
- 4640, 7750, 10000 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
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 10 000 mg/kg bw
- Based on:
- test mat.
- Clinical signs:
- Within 2 hours after treatment the rats in all dosage groups showed sedation, dyspnoea, curved position and ruffled fur.
- Gross pathology:
- No gross organ changes
Any other information on results incl. tables
The surviving animals had recovered within 7 to 8 days. They were killed and autopsied after an observation period of 14 days.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP criteria not met
- Conclusions:
- LD50 > 10000 mg/kg bw
- Executive summary:
The substance was tested in rats of both sexes observed over a period of 14 days. The substance was administered by oral gavage at 4640, 7750 and 10000 mg/kg bw.
The acute oral LD50 of the test substance was found to be greater than 10000 mg/kg bw.
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