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Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report date:
2006

Materials and methods

Test guideline
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

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 liquid original compound was used

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: 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

Administration / exposure

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

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:
No findings

Any other information on results incl. tables

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.

Applicant's summary and conclusion

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.