Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
from January to May, 1983
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report Date:
1983

Materials and methods

Principles of method if other than guideline:
Not specified.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: 9 - 14 weeks of age.
- Weight at study initiation: 155 - 191 g (males), 152 - 189 m (females).
- Housing: 5 per cage.
- Diet: pellet suspended from 16 h before to 4 h post exposure.
- Water: ad libitum.

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 0.5 °C.
- Humidity: 60 ± 5 %.
- Photoperiod: 12 hrs dark / 12 hrs light.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Doses:
1000, 2000, 2500, 3100, 5000 mg/kg bw.
No. of animals per sex per dose:
5 animal/sex/dose.
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days.
- Frequency of observations: twice daily.
- Other examinations performed: clinical signs (position, sedation, diarrhoea); histopathological examination of dead animals.
Statistics:
LD50 value with p lower than 0.05 computed based on Rosiello et al., J. Tox. Environ. Health 3, 1977, 797.

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
2 400 mg/kg bw
Based on:
test mat.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 1 600 mg/kg bw
Based on:
act. ingr.
Mortality:
Mortality occurred within 2 hours from administration.
Clinical signs:
Symptoms, as reduction of general conditions, sedation and diarrhoea, were evident starting from 10 minutes up to 3 days after administration.
Gross pathology:
Stomach and intestines of dead animals dosed from 2000 to 5000 mg/kg bw could not be evaluated due to discoloration.
The other organs at dosages 1000-3100 mg / kg showed no compound-related changes.

Any other information on results incl. tables

Results in female rats

doses mg/kg no. animals no. dead animals no. animals with symptoms time of death duration of symptoms
1000 5 0 0
2000 5 1 5 2 h  10 min to 3 d
2500 5 3 5 2 h  10 min to 3 d
3100 5 5 5 2 h  10 min to 3 d
5000 5 5 5 1h 1/2 10 min to 3 d

Results in male rats

doses mg/kg no. animals no. dead animals no. animals with symptoms time of death duration of symptoms
1000 5 0 0
2000 5 0 5 10 min to 3 d
2500 5 2 5 2 h  10 min to 3 d
3100 5 4 5 1 h 1/2 10 min to 3 d
5000 5 5 5 1h 1/2 10 min to 3 d

Overall mortality

doses mg/kg no. animals mortality %
1000 10 0
2000 10 10
2500 10 50
3100 10 90
5000 10 100

Applicant's summary and conclusion

Interpretation of results:
other: Category 4 based on CLP criteria
Conclusions:
Acute oral exposure of rats to the substance lead to LD50 = 2400 mg/kg bw, equivalent to ca. 1600 mg/kg bw as active ingredient. Higher toxicity in female than in male rats was noted.
Executive summary:

Method

Acute oral toxicity by gavage in both male and female rats with a 14-day observation period.

Results

LD50 of 2400 mg/kg for both male and female rats, equivalent to ca. 1600 mg/kg bw of active ingredient for the given purity of test material. Female rats showed higher sensitivity than males to the substance. Mortality occurred within 2 hours from administration. At necropsy, stomach and intestines of dead animals dosed from 2000 to 5000 mg/kg bw could not be evaluated due to discoloration; the other organs at dosages 1000 - 3100 mg / kg bw showed no compound-related effects.