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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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 28, 1976
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Remarks:
The reliability assigned to this study is 4 as the composition of the active ingredient in the test item is low.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report date:
1976

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 Brown 001
IUPAC Name:
Vat Brown 001
Test material form:
solid: particulate/powder

Test animals

Species:
rat
Strain:
other: Tif RAlf
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: CIBA-GEIGY LIMITED
- Weight at study initiation: from 105 to 115 grams
- Fasting period before study: animals fasted overnight before treatment
- Housing: in groups of 5 in Macrolon cages
- Diet (e.g. ad libitum): standard diet of pellets - No. 890, Nafag Gossau SG ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: for a minimum of 5 days before treatment

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1 °C
- Humidity (%): 55 ± 5 %
- Photoperiod (hrs dark / hrs light): 14 hours light cycle day

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: distilled water
Doses:
1000, 3000, 10000, 15000 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: 15 days
- Other examinations performed: clinical signs, body weight,organ

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 15 000 mg/kg bw
Based on:
test mat.
Mortality:
no deaths occured
Clinical signs:
At 10000 mg/kg bw: reduction in spontaneous motility, ataxia, muscular hypotonia. Symptoms lasting >6 hours. After 24 hours no symptoms.
At 15000 mg/kg bw: ditto, diarrhea.

Applicant's summary and conclusion

Interpretation of results:
other: CLP criteria not met
Conclusions:
LD50 > 15000 mg/kg bw
Executive summary:

The acute oral LD50 of the test substance in rats of both sexes observed over a period of 15 days is >15000 mg/kg bw.