Methyl valerate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

August to September 2002

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

4 animals (2M, 2F)

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 / tissue source

Species:

rabbit

Strain:

New Zealand White

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: the left eye, which remained untreated, served as control.

Amount / concentration applied:

0.1 mL

Duration of treatment / exposure:

test substance remained in the eye (eye was not rinsed)

Observation period (in vivo):

4 days

Number of animals or in vitro replicates:

2 females, 2 males

Details on study design:

0.1 mL corresponded to ca. 91 mg

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Remarks:

reddening

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0.5

Max. score:

3

Reversibility:

fully reversible within: 7 days

Results 4

Irritation parameter:

conjunctivae score

Remarks:

swelling

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0.25

Max. score:

4

Reversibility:

fully reversible within: 3 days

Any other information on results incl. tables

Table 1: Results of the study

		Irritant effects (score)
Animal no. (sex)	Irritation parameter	24 h	48 h	72 h	Mean scores
1 (M)	Cornea	0	0	0	0.0
	Iris	0	0	0	0.0
	Conjunctiva (reddening)	0	0	0	0.0
	Conjunctiva (swelling)	0	0	0	0.0
2 (M)	Cornea	0	0	0	0.0
	Iris	0	0	0	0.0
	Conjunctiva (reddening)	0	0	0	0.0
	Conjunctiva (swelling)	0	0	0	0.0
3 (F)	Cornea	0	0	0	0.0
	Iris	0	0	0	0.0
	Conjunctiva (reddening)	1	1	1	1.00
	Conjunctiva (swelling)	1	0	0	0.33
4 (F)	Cornea	0	0	0	0.0
	Iris	0	0	0	0.0
	Conjunctiva (reddening)	1	1	1	1
	Conjunctiva (swelling)	1	1	0	0.67

The control eyes were without findings.

A single application of 0.1 ml ZK 28520 into the conjunctival sac of the rabbit eye led to slight to moderate secretion, reddening and swelling of the outer eyelids and eyelid closure mainly on days 1-2. Additionally, reddening and swelling of the conjunctivae were observed which were slight to moderate up to day 2, while slight conjunctival reddening and/or vascular injection were observed up to day 7. One animal was without findings on day 2, while the other animals were without findings on days 7 or 8.

Applicant's summary and conclusion

Interpretation of results:

other: slight to moderate irritation which is fully reversible on day 7

Executive summary:

In a local tolerance test on the rabbit eye similar to OECD TG 405 a single application of the test substance into the conjunctival sac provoked on the whole slight irritation which lasted up to day 7. The mean values of findings relevant for classification at the time-points 24, 48 and 72 hours after application were 0 for the parameters cornea and iris, 0.25 for conjunctival swelling and 0.50 for conjunctival reddening. According to EU classification criteria the test substance need not be labelled as an eye irritant.