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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
Study period:
From 17 JUL 1992 to 31 JUL 1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study (EPA TSCA, 40 CFR 798)
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: EPA TSCA, 40 CFR 798
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Ave Animals
- Age at study initiation: ~8 weeks
- Weight at study initiation: males: 257 - 278 g; females: 205 - 248 g
- Fasting period before study: 16 to 17 h
- Housing: in cages in groups of five by sex
- Diet: Fresh Purina Rat Chow (Diet #5012), ad libitum
- Water, ad libitum
- Acclimation period: at least one week

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 0.5 g/mL (20 g of test article was added to corn oil for total volume of 40 mL)

MAXIMUM DOSE VOLUME APPLIED: 1 mL/100 g body weight for non-aqueous vehicles and 2 mL/100 g body weight for aqueous solutions

Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: 1, 2 and 4 hours post dose and once daily for 14 days toxicity and pharmacological effects, twice daily for 14 days for mortality
- Frequency of weighing: weekly
- Necropsy of survivors performed: yes
Statistics:
The LD50, 95% Confidence limits, dose response curve and slope were calculated, if possible, according to the method of Litchfield and Wilcoxon, 1949 or Horn, 1956.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Remarks on result:
other: no animals died within the 14 days observation period
Mortality:
- no deaths occurred
Clinical signs:
- one animal had diarrhea 4 hours post appilcation
- in all animals the anogenital area was stained purple on days 1 and 2
Body weight:
- body weight development was not impaired
Gross pathology:
- all animals were sacrificed at the end
- only in one male animal there was a herniated liver protruding through the diaphragm
- in all other animals no macroscopically visible changes were found

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: other: CLP regulation
Conclusions:
Single application of the limit dose of 5000 mg test item per kg bw did not cause lethality in male and female Wistar rats during the 14 days observation period, resulting in a LD50 > 5000 mg/kg bw.
Executive summary:

Acute oral toxicity of the test item was tested in male and female Wistar rats according to EPA TSCA, 40 CFR 798. The test was conducted administering the limit dose of 5000 mg/kg bw to 5 animals/sex. During the 14 days observation period no animals died and there were no toxicological relevant changes found in necropsy, thus leading to a median lethal dose (LD50) > 5000 mg/kg bw.

Therefore, the test item has not to be classified for acute oral toxicity according to Regulation (EC) No 1272/2008.