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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
other: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
from October 25 to November 30, 1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
The test was conducted by means of Read Across approach. Further information was attached at section 13

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report date:
1979

Materials and methods

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

Test material

Constituent 1
Reference substance name:
Acid Yellow 151:1 - Similar Substance 01
IUPAC Name:
Acid Yellow 151:1 - Similar Substance 01
Test material form:
solid: particulate/powder

Test animals

Species:
rat
Strain:
other: RAIf (SPF)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Tif
- Age at study initiation: 7 to 8 weeks old
- Weight at study initiation: males 206.5 g, females 182 g
- Fasting period before study: Animals fasted overnight
- Housing: 5 in Macrolon cages (type 3)
- Diet: ad libitum rat food NAFAG, Gossau SG
- Water: ad libitum
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 °C
- Humidity (%): 55 ± 10 %
- Photoperiod: 10 hours of light during the day

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: carboxymethyl-cellulose 2 % (w/v) in dest. water
Details on oral exposure:
VEHICLE
- Concentration in vehicle:20 ml/kg bw
Doses:
5000, 7000, 8000, 10000 mg/kg
No. of animals per sex per dose:
5 x sex x doses
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:Bodyweights were recorded immediately prior to dosing (control weights) and at 7 and 14 days
- Necropsy of survivors performed: yes
Statistics:
LD50 including 95 % confidence limits are calculated by the logit model.

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD0
Effect level:
ca. 10 000 mg/kg bw
Based on:
test mat.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 10 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality observed
Clinical signs:
Dhiarroea, Ruffled fur, Dyspnoea.
Gross pathology:
No substance related gross organ changes were seen

Applicant's summary and conclusion

Interpretation of results:
other: CLP criteria not met
Conclusions:
LD50 > 10000 mg/kg bw.
Executive summary:

The acute oral LD50 of test substance in rats of both sexes observed over a period of 14 days is greater than 10000 mg/kg bw. The test material has therefore practically no acute toxicity to the rat by this route of administration.