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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
other: read across from supporting substance
Adequacy of study:
key study
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:
1975
Report Date:
1975

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Remarks:
Study conducted before 1981
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: 7 weeks
- Weight at study initiation: 192 g (♂) and 151 g (♀).
- Housing: Rats were caged singly
- Diet: A commercial pelleted diet ad libitum
- Water: ad libitum
- Fasting period before study: 18 hours

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 2 °C

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: a 25 % (w/v) suspension of the compound in tap water.
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5 per sex per dose
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
Deaths and clinical symptoms wars recorded. At the end of the observation period, surviving animals were killed by exsanguination under ether anaesthesia and an autopsy performed.

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Sex:
male/female
Dose descriptor:
LD0
Effect level:
ca. 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occurred during the 14 day observation period.
Clinical signs:
No clinical symptoms were recorded
Gross pathology:
At autopsy no changes in organs or tissues caused by the administration of the test compound were seen.

Applicant's summary and conclusion

Interpretation of results:
other: Not classified according to the CLP Regulation (EC n. 1272/2008)
Conclusions:
LD50(male/female) > 5000 mg/kg bw
Executive summary:

The substance has been tested for acute toxicity after oral exposure, the test item was administered by gavage in a single dose of 5000 mg/kg bw to rats (5 male and 5 female).

After the administration, the animals were observed for 14 days. No deaths occurred and no clinical symptoms were recorded.

The acute oral median lethal dose LD50 of test item in rats is greater than 5000 mg/kg bw.