Methyl valerate

Acute Toxicity: oral

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

Test material information

Constituent 1

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 pentanoate

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:

other: no clinical signs

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.