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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
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:
1972
Report Date:
1972

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
Higher doses tested, only 8 days observation
GLP compliance:
no
Test type:
fixed dose procedure

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Pergasoltürkisblau RAL
Specific details on test material used for the study:
FAT 2006 (Pergasoltürkisblau RAL)

Test animals

Species:
rat
Strain:
other: Tif RAIf
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: purchased from breeder
- Weight at study initiation: average of 100 g
- Housing: rats were caged in groups of five
- Diet: commercial diet of Nafag
- Water: ad libitum.
- Selection: healthy rats
-Acclimatization: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 1 °C
- Photoperiod: 12 hours artificial light and 12 hours darkness.
-Humidity 55%

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Remarks:
deionized
Details on oral exposure:
10000 mg/kg is 100%
6000 mg/kg is 60% in water
3000 mg/kg bw is 30% in water
1000 mg/kg bw is 10% in water

The tolal volume given was 10 ml/kg body weight
Doses:
1000, 3000, 6000 and 10000 mg/kg bw
No. of animals per sex per dose:
5 males and 5 females per dose
Details on study design:
- Duration of observation period following administration: 7 days
- Necropsy of survivors performed: at the end of the observation period, surviving animals were killed by exsanguination under ether anaesthesia and an autopsy performed.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 10 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occurred.
Clinical signs:
reduction in spontaneous motility and ataxia lasting about 60 minutes at 1000 mg/kg bw
At higher doses, there was also transient ventricumbency (3000) and muscular hypotonia and hypoventilation (6000 and 10000 mg/kg bw).
Body weight:
In all dose groups, rats gained 42-48g during the 8-day observation period.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
LD50 > 10000 mg/kg bw