Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1979-10-05-1979-12-03
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study

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:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
hamster, Chinese
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: 4-6 weeks old
- Weight at study initiation: 27-37g
- Housing: Individually in Macrolon cages
- Diet: NAFAG, Gossau SG, ad libitum
- Drinking water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2°C
- Humidity (%): 55 +/- 10 %
- Photoperiod: 10 hours light

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
polyethylene glycol
Details on oral exposure:
DOSAGE PREPARATION: The test item was suspended to achieve the corresponding dosage level. Before treatment the suspension was homogeneously dispersed with an Ultra-Turrax and during treatment it was kept stable with a magnetic stirrer.
Volume: 10 and 20 mL/kg body weight
Doses:
3000, 4000, 5000, 6000 mg/kg bw
No. of animals per sex per dose:
5 male
5 female
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: Bodyweight: Immediately prior to dosing and after 7 and 14 days.
Clinical observations: Daily

Results and discussion

Preliminary study:
none
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 6 000 mg/kg bw
Based on:
test mat.
Mortality:
no mortality
Clinical signs:
Total recovery within 7-8 days
Sedation:
Slight effects, recovery after 2 days (3000 mg/kg)
Slight effects, recovery after 5 days (all other dose groups)
Dyspnoe:
Slight effects, recovery after 7 days (3000 mg/kg)
Slight effects, recovery after 6 days (all other doses)

Exophthalmos
slight effects, recovery after 5 hours (dose group 3000 mg/kg)
slight effects, recovery after 24 hours (dose group 4000 mg/kg)
slight effects, recovery after 2 days (dose group 5000 mg/kg)
slight effects, recovery after 3 days (dose group 6000 mg/kg)

Ruffled fur
Slight effects, recovery after 6 days (Dose group 3000 mg/kg)
Slight and moderate effects, recovery after 6 days (dose group 4000 mg/kg)
Slight and moderate effects, recovery after 5 days (dose group 5000 mg/kg)
Slight and moderate effects, recovery after 6 days (dose group 6000 mg/kg)

Body position (curved)
Slight effects, recovery after 2 days (4000 mg/kg)
Slight effects, recovery after 2 days (5000 mg/kg)
Slight effects, recovery after 2 days (6000 mg/kg)
Body weight:
Reduction of bodyweight in the dose group of 4000 mg/kg from 37 g to 34 g (males after 14 days) and from 30 g to 27 g (females after 14 days).
Reduction of bodyweight in the highest dose group of 6000 mg/kg from 30 to 28 g (females after 14 days).
Gross pathology:
No substance related gross organ changes were seen.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met