Methyl valerate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

from August 2002 to February 2003

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Cross-reference

Reason / purpose for cross-reference:

reference to same study

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.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Report date:

2006

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

- exposure time 24 hrs instead of 4 hrs, 6 animals instead of 3, few details in test description and reporting

GLP compliance:

not specified

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 liquid original compound was used

Test animals

Species:

rat

Strain:

other: Shoe: WIST (SPF)

Test system

Type of coverage:

not specified

Preparation of test site:

not specified

Vehicle:

unchanged (no vehicle)

Controls:

other: the untreated skin served as control

Amount / concentration applied:

2000 mg/kg bw

Duration of treatment / exposure:

24 hours

Observation period:

14 days

Number of animals:

3 males and 3 females

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24, 48, 72 hours

Score:

0.78

Max. score:

4

Reversibility:

fully reversible within: 6 days

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

4

Any other information on results incl. tables

Test compound ZK 56406 (2000 gm/kg)		Animal number and sex
Location (finding)	Time-point after end of exposure	20M	21M	22M	4F	5F	6F
Reddening and scab formation	1 hour*	0	0	0	0	0	0
	24 or 25 hours	2	2	0	0	0	0
	48 hours	2	2	0	0	1	1
	72 hours	2	2	0	0	0	0
Individual mean values:		2	2	0	0	0.33	0.33
Mean value of all animals:							0.78
Swellings	1 hour*	0	0	0	0	0	0
	24 or hours	0	0	0	0	0	0
	48 hours	0	0	0	0	0	0
	72 hours	0	0	0	0	0	0
Individual mean values:		0	0	0	0	0	0
Mean values of all animals:							0

*         = not included in calculations of mean values

Applicant's summary and conclusion

Interpretation of results:

other: very slight local intolerance reactions up to day 6.

Executive summary:

After a single dermal administration of the test substance for 24 hours to male and female rats at a dose of 2000 mg/kg very slight local intolerance reactions at the administration area and above were observed up to day 6. The mean values of findings relevant for classification (reddening, scab formation and swelling of the skin) at the time-points 24, 48 and 72 hours after the end of administration were 0.