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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
4th June 1993 to 18th June 1993
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report date:
1993

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OTS 798.1175 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1

Test animals

Species:
rat
Strain:
other: Crl:CD(R)BR
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: Young adult
- Weight at study initiation: 219-294 g
- Fasting period before study: 18-20 hours
- Housing: Individual suspended wire-mesh cages
- Diet: ad libitum
- Water: ad libitum (tap water)
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-22 °C
- Humidity (%): 48-90 %
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5 animals per sex per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Rats were examined for mortality and clinical observations at 1, 3, and 4 hours post dosing on day 0. The animals were observed for mortalty twice daily thereafter (morning and afternoon) and once daily for clinical observations until day 14. Body weights were examined on days -1, 0 (initation), 7 and 14 (study termination).
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
There were no unscheduled deaths during the study
Clinical signs:
All animals demonstrated abnormal defecation (soft stool, diarrhea, mucoid faeces or decreased faeces), wet or dried yellow urogenital/abdominal staining and various dried red stainings around the nose, mount and or forepaws. Six rats had dried or wet yellow staining around the mouth. Wet and/or drid brown urogenital staining was noted for two rats. There were single occurences of hypoactivity and clear wet matting around the mouth. One rat had clear ocular discharge at the 3 and 4 hour post dose observation. There were no other clinical findings. All animals appeared normal on days 13 and 14.
Body weight:
Three rats between the days 0 to 7 lost between 6 and 48 grams. These rats gained weight during the second week of the study, surpassing day 0 body weight by day 14. There were no other significant changes or differences in body weights during the study.
Gross pathology:
One male had small soft testes considered to be a congenital abnormality at the terminal necropsy. No other significant changes observed for all examined tissues at the terminal necropsy.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of the test, the LD50 of the test material was determined to be greater than 5000 mg/kg bw in male and female rats.
Executive summary:

The acute oral toxicity of the test material was determined in a study performed in accordance with OECD 401, EU Method B.1 and EPA OTS 798.1175. Under the conditions of the test, the LD50 of the test material was determined to be >5000 mg/kg bw in male and female rats.