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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:
key study
Study period:
1987
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified
Details on test material:
- Name of test material (as cited in study report): FAT 400045/C
- Substance type: Dye
- Analytical purity: 100 %
- Lot/batch No.: EN 19609.62
Specific details on test material used for the study:
Test substance: FAT 400045/C
Batch No.: EN 19609.62

Test animals

Species:
rat
Strain:
other: albino
Sex:
male/female
Details on test animals and environmental conditions:
not available

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Details on oral exposure:
no data
Doses:
2000 and 5000 mg/kg bw
No. of animals per sex per dose:
3

Control animals:
not specified
Statistics:
no data

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
approximate LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred at the dose of 2000 mg/kg bw. In the rats administered 5000 mg/kg bw, 1/3 males and 1/3 females were found dead during the observation period.
Clinical signs:
Dyspnoea, exophthalmos, ruffled fur, and curved body position were seen, being common symptoms in acute toxicity testing. The surviving animals recovered within 10-12 d.
Body weight:
No data
Gross pathology:
At autopsy, no deviations from normal morphology were found in the animals of the 2000 mg/kg bw dose group.
The gastrointestinal tract was dilated in the male and the female of the 5000 mg/kg bw dose group which died on day 1.
Other findings:
no data

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The oral LD50 of the test substance was >5000 mg/kg bw in rats.
Executive summary:

A study was conducted to assess the acute oral toxicity of the test substance in albino rats following a method comparable to OECD Guideline 401. Two groups of rats (3/sex/dose) received a single oral (gavage) dose of either 2000 or 5000 mg/kg bw of the test substance. No mortality occurred at 2000 mg/kg bw. However, in the rats administered 5000 mg/kg bw, 1/3 males and 1/3 females were found dead during the observation period. Dyspnoea, exophthalmos, ruffled fur and curved body position, being common symptoms in acute toxicity studies, were seen in treated animals. Surviving animals recovered within 10-12 d. At autopsy, no deviations from normal morphology were found at 2000 mg/kg bw. The gastrointestinal tract was dilated in the male and the female of the 5000 mg/kg bw dose group which died on Day 1. Based on these findings, the approximate oral LD50 of the test substance was considered to be >5000 mg/kg bw in rats.