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:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

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:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hagemann, Germany
- Fasting period before study: 15 - 20 h prior to test start
- Diet (e.g. ad libitum): Herilan, ad libitum
- Water (e.g. ad libitum): ad libitum

IN-LIFE DATES: From: 31 Oct 1979 To: 13 Nov 1979

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
single dose received by gavage
emulsion prepared with aqua dest.
applied volume: 10 mL/kg
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
Observation period: 14 d after test substance administration
Statistics:
Determination of LD50: statistically if possible

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
No mortality observed
Clinical signs:
None
Body weight:
Initial mean: 180 g (male); 160 (female)
End of study: 294 g (male); 198 g (female)
Gross pathology:
Organs w/o any findings
Other findings:
None

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 (oral, gavage) in male and female rats was determined >5000 mg/kg bw. The substance is not classifiable according to CLP criteria.