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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
July to August 2002
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report date:
2002

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
not specified
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Methyl valerate
EC Number:
210-838-0
EC Name:
Methyl valerate
Cas Number:
624-24-8
Molecular formula:
C6H12O2
IUPAC Name:
methyl valerate
Test material form:
liquid
Specific details on test material used for the study:
- Solubility and stability of the test substance in the solvent/vehicle: The formulation (emulsion) was prepared freshly on treatment day and the administrations were carried out within 1 hour after formulation.

Test animals

Species:
rat
Strain:
other: Shoe: WIST (SPF)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Tierzüchter Schönwalde GmbH, Schönwalde, Germany

- Age at study initiation: no data
- Weight at study initiation: 102-118 g (males); 95-104 g (females)
- Fasting period before study: approximately 18 hours
- Housing: conventional (1 animal per cade)
- Diet (ad libitum): pell. Ssniff R/M
- Water (ad libitum): demineralized, acidified water, pH 2-3
- Acclimation period: <= 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22-23
- Humidity (%): 46-62
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 9 mg NaCI + 0,85 mg Myrj 53 ad 1 mL Aqua p.i.
Doses:
2000 mg/kg
No. of animals per sex per dose:
3
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
no mortality
Clinical signs:
no clinical signs
Body weight:
no effect on body weight gain
Gross pathology:
A diminished size of testes, epidydimis, prostate and seminal vesicle in all male animals and of uterus and ovaries in all female animals.

Applicant's summary and conclusion

Executive summary:

A single oral administration of the test substance by gavage to male and female rats at the limit-dose 2000 mg/kg was tolerated without mortalities, clinical signs and effects on body weight gain.and gross pathological findings. Macroscopic examinations revealed a diminished size of testes, epidydimis, prostate and seminal vesicle in all male animals and ofuterus and ovaries in all female animals. According to OECD TG 423 the oral LD50 of the test substance is therefore > 2000 mg/kg body weight.