Registration Dossier

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: Basic data given.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1969
Report Date:
1969

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
only 8 days instead of 14 d observation period, only males tested, lack of details on test substance
GLP compliance:
no
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): hardened ricinus oil
- Analytical grade: no data
- Physical state: not stated

Test animals

Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals and environmental conditions:
no data

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: Cremophor EL (BASF)
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 40% emulsion
- pH of emulsion: 5.6

MAXIMUM DOSE VOLUME APPLIED: 5 mL/kg bw
Doses:
20 g/kg bw
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
- Duration of observation period following administration: 8 days

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
> 20 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: rat
Mortality:
No deaths occured.
Clinical signs:
All treated animals showed increased respiration rate, ruffled fur and diarrhoe.
No further details reported.

Applicant's summary and conclusion

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