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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report date:
2017

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
2-propylvaleronitrile
EC Number:
236-338-2
EC Name:
2-propylvaleronitrile
Cas Number:
13310-75-3
Molecular formula:
C8H15N
IUPAC Name:
2-propylpentanenitrile

Test animals

Species:
rat
Strain:
other: Crl:WI(Han)
Sex:
female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
300 and 2000 mg/kg
No. of animals per sex per dose:
3 females/dose
Control animals:
no

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
>= 300 - <= 2 000 mg/kg bw
Based on:
test mat.
Mortality:
There were no deaths at a dose level of 300 mg/kg. Two animals dosed at 2000 mg/kg were found dead two days after dosing on Day 3. One other animal was humanely killed due to the severity of the clinical signs at this time point.
Clinical signs:
No clinical signs were seen at a dose level of 300 mg/kg.
Piloerection and ataxia or decreased activity were noted in all animals treated at 2000 mg/kg one day after dosing. Piloerection, ataxia, decreased activity and hunched posture were noted in these animals on Day 3. One animal treated at 2000 mg/kg was prone and gasping on Day 3 and was humanely killed. All surviving animals appeared normal from Day 4.
Body weight:
All surviving rats achieved body weight gains during the first and second weeks of the study except for one animal treated at 2000 mg/kg which showed a slight loss in body weight during the first week.
Gross pathology:
No abnormalities were noted at necropsy.

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
The acute median lethal oral dose level of the test article, 2-propylvaleronitrile (CAS 13310-75-3), was found to be between 300 and 2000 mg/kg.
The test material was classified as Category 4 in respect of its acute oral toxicity according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS).

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