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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Equivalent or similar to the OECD Guideline 401 (TS purity not specified; 7-day observation period; body weights determined only at study start; no GLP)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1973
Report Date:
1973

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
7-day observation period; body weights determined only at study start
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
No additional details provided

Test animals

Species:
rat
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Tif. RAI SPF own breeeding rats from Ciba-Geigy Ltd.
- Age at study initiation: 6-7 weeks
- Weight at study initiation: 160-180 g
- Fasting period before study: during one night prior to dosing
- Housing: caged in groups of 5 (segregated in males and females) in Macrolon cages type 3
- Diet (e.g. ad libitum): Rat food, NAFAG, Gossau, SG; ad libitum
- Water (e.g. ad libitum): drinking water; ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS (the animal room was air conditioned)
- Temperature (°C): 22±1°C
- Humidity (%): approx. 50%

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Remarks:
2%
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 50% (w/v)

DOSAGE PREPARATION (if unusual):
The test substance was weighed into an Erlenmeyer flask on a Mettler balance. It was suspended at 50 % with CMC (2%). Before treatment the suspension was homogeneously dispersed with an Ultra-Turrax and during treatment it was kept stable with a magnetic stirrer.
Doses:
6000 and 10000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: daily for mortality and clinical signs of toxicity; body weights were not determined
- Necropsy of survivors performed: yes; the animals were killed and autopsied at the end of the observation period.
Statistics:
None conducted

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 10 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality was observed up to this dose level
Mortality:
No mortality occurred
Clinical signs:
Within 2 hours after treatment the rats of both dosage groups showed dyspnoea, exophthalmus, curved position and ruffled fur. These symptoms became more accentuated as the dose was increased. The animals had recovered within 3 to 6 days. They were killed and autopsied after an observation period of 7 days.
Body weight:
No data
Gross pathology:
No substance related gross organ changes were seen.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information