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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:
other: no GLP; short report

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Remarks:
pre-dates GLP regulation
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified
Details on test material:
no data

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River UK Ltd. Margate UK
- Age at study initiation: 4 to 6 weeks
- Weight at study initiation: 70 to 90 g
- Fasting period before study: 21 h
- Housing: no data
- Diet (e.g. ad libitum): ad ibitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 +/- 2 C
- Humidity (%): ca 47%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 40 %
- Justification for choice of vehicle: Water is the vehicle of joice whenever possible.

MAXIMUM DOSE VOLUME APPLIED: 12.5 ml/kg
Doses:
0 mg/kg bw ( Control)
5000 mg/kg bw (treated)
No. of animals per sex per dose:
5
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: twice daily
- Frequency ofweighings: days 1, 8, and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weights

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD0
Effect level:
5 000
Based on:
test mat.
Remarks on result:
other: No mortality occurred
Mortality:
None
Clinical signs:
Piloerection, hunched posture, and abnormal gait (waddling) occurred shortly after dosing. Piloerection was abserved also in the control group.
Body weight:
No adverse effects observed.
Gross pathology:
No abnormal findings
Other findings:
none.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The oral gavage of 5000 mg/kg bw of the test material did not cause mortality in male and female rats.
Executive summary:

The oral gavage of 5000 mg/kg bw of the test material did not cause mortality in male and female rats. Clinical signs were limited to temporary piloerection hunched posture and abnormal gait shortly after treatment. No adverse effects on body weights or the macroscopic appearance of organs were detected.