Methyl valerate

Endpoint summary

Description of key information

Acute toxicity: via oral route

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.

Acute toxicity: via dermal route

A single dermal administration of the test substance to male and female rats at the limit-dose 2000 mg/kg was tolerated without mortalities, compound-related clinical findings, effects on body weight gain and gross pathological findings. According to OECD TG 402 the dermal LD50 of the test substance is therefore > 2000 mg/kg body weight.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

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

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

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.

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

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

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.

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

2 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

from August 2002 to February 2003

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

- 3 (females) and 9 (males) instead of 5 animals/sex used

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

Specific details on test material used for the study:

- Solubility and stability of the test substance in the solvent/vehicle: The liquid original compound was used

Species:

rat

Strain:

other: Shoe: WIST (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Tierzucht Schönwald GmbH, schönwald, germany
- Age at study initiation: 8-9 weeks
- Weight at study initiation: 263-328 g (males); 181-188 g (females)
- Housing: conventional; 1 animal per cage
- Diet (ad libitum): pell. Ssniff R/M
- Water (ad libitum): demineralized, acidified, pH 2-3
- Acclimation period: >= 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22-23
- Humidity (%): 54-62
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:

not specified

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

step I (3 males 2000 mg/kg (nominal)) had to be repeated because the application volume was to low.
step II (3 males 2000 mg/kg) had to be repeated because inadvertently the application areas were not observed 48 and 72 after termination of treatment.

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3 (females)
9 (males)

Control animals:

no

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:

No findings

The slight decrease in body weight in one male animal on day 7 was not considered to be compound related because it was noted in one male animal only.

Executive summary:

A single dermal administration of the test substance to male and female rats at the limit-dose 2000 mg/kg was tolerated without mortalities, compound-related clinical findings, effects on body weight gain and gross pathological findings. According to OECD TG 402 the dermal LD50 of the test substance is therefore > 2000 mg/kg body weight.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

2 000 mg/kg bw

Additional information

Acute toxicity: via oral route

There is only one study avaialble.

Acute toxicity: vial inhalation route

The endpoint study record named "rel. 4 information from RTECS" in chapter 7.2.2 of the IUCLID dossier refers to a publication which is not suitable for the hazard assessment. Therefore

"No study available" was selected for the endpoint conclusion with regard to this exposure route.

Acute toxicity: via dermal route

There is only one study available.

Justification for classification or non-classification

Based on the study results a classification according to Regulation (EC) No. 1272/2008 (CLP) is not required.