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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
Remarks:
(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
Test material form:
solid

Test animals

Species:
rat
Strain:
other: albino rats
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: overnight prior to dosing
- Housing: caged in groups of 5 in Macrolon cages type 3
- Diet: Rat food, NAFAG, Gossau, SG, rat food; ad libitum
- Water: drinking water; ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS (the animal room was air conditioned)
- Temperature (°C): 22 ± 1
- Humidity (%): approx. 50
- Air changes (per hr): approx. 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Remarks:
2%
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 30% (w/v)

DOSAGE PREPARATION:
The test substance was weighed into an Erlenmeyer flask on a Mettler balance. It was suspended at 30 % 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 7750 mg/kg bw (it was not possible to evaluate higher dose level)
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 after an observation period.
Statistics:
None conducted

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 7 750 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 sedation, dyspnoea, exophthalmus, curved position and ruffled fur. The animals recovered within 4 to 6 days.
Body weight:
No data
Gross pathology:
No substance related gross organ changes were seen.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met