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Toxicological information

Acute Toxicity: oral

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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:
1975
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

Constituent 1
Reference substance name:
Vat Red 013
IUPAC Name:
Vat Red 013
Test material form:
not specified

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.