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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Only summary of the results given

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report Date:
1991

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
limited reporting, only 8 days obeservation
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Only trade name given
- Analytical purity: no data
- Lot/batch No.: Bx160491

Test animals

Species:
rat
Strain:
other: ALpk:AP
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: ICI Pharmaceuticlas, Alderley Park, Cheshire, UK
- Age at study initiation: approx. 6-10 weeks
- Weight at study initiation: 239 - 250 g (males); 184 - 202 g (females)
- Fasting period before study: 24 h
- Diet: ad libitum
- Water: ad libitum

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
VEHICLE
- Amount of vehicle (if gavage): 10 mL/kg bw

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
other: not required
Details on study design:
- Duration of observation period following administration: 8 days
- Frequency of observations and weighing: prior to fasting, immediately prior dosing and at the end of the study
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
None of the animals died during the observation period of 8 days.
Clinical signs:
No significant signs of toxicity were observed.
Body weight:
All animals lost weight initially due to a predose fast but all had exceeded their initial bodyweight by day 3 and weight gain continued until the end of the study.
Gross pathology:
There were a small number of gross abnormalities at post mortem (not further specified). These were part of a spectrum of known background changes seen in this rat strain and considered not to be treatment related.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified