Registration Dossier

Diss Factsheets

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: Guideline study obtained through inquiry process; SNIF file obtained from ECHA.

Data source

Reference
Reference Type:
other: SNIF
Title:
Unnamed
Year:
1993

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
Qualifier:
according to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Deviations:
not specified
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Body responsible for the test
IUPAC Name:
Body responsible for the test
Test material form:
not specified

Test animals

Species:
rat
Strain:
not specified
Sex:
male/female

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
other: 0.5% (w/v) CMC in 0.1% aqueous polysorbate 80
Doses:
Male: 2000 mg/kg bw
Female: 2000 mg/kg bw
No. of animals per sex per dose:
Male: number of animals 5
Female: number of animals 5
Control animals:
not specified

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
not specified
Mortality:
Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Clinical signs:
Signs of toxicity related to dose levels:
Common symptoms in acute tests (piloerection, hunched posture, exophtalmos, dyspnea). The animals recovered within 6-7 days. Additionally, reduced locomotor activity was observed in all animals.
Body weight:
no data
Gross pathology:
Effects on organs: none

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: other: EU-GHS
Conclusions:
LD50 >2000 mg/kg bw
Executive summary:

The acute oral toxicity of the test substance has been determined in a GLP test with rats according to OECD Guideline 401 and EU method B.1 in a limit test. The LD50 value was > 2000 mg/kg bw, the test substance showed no toxicity under the conditions of the test.

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