Methyl octanoate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

weight of evidence

Study period:

11 Mar - 31 Mar 1988

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study with acceptable restrictions (lack of individual tabulated data on cornea and iris; reading at 72 h in only 1 animal)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

lack of details on test substance; lack of individual tabulated data on cornea and iris; reading at 72 h in only 1 animal

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

lack of details on test substance; lack of individual tabulated data on cornea and iris; reading at 72 h in only 1 animal

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, C6-10, Me esters

EC Number:

273-094-6

EC Name:

Fatty acids, C6-10, Me esters

Cas Number:

68937-83-7

IUPAC Name:

68937-83-7

Details on test material:

- Name of test material (as cited in study report): Only trade name given
- Substance type: Fatty acid methyl ester, C6-10
- Physical state: clear yellowish liquid
- Analytical purity: no data

Test animals / tissue source

Species:

rabbit

Strain:

other: Kleinrusse, Chbb:HM

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Thomae GmbH, Biberach, Germany
- Weight at study initiation: mean 2467.5 g
- Housing: individually
- Diet: Altromin Haltungsdiät 2023, ad libitum
- Water: ad libitum
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 21
- Humidity (%): 45 - 55
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: the untreated eye served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL

Duration of treatment / exposure:

single application without washing

Observation period (in vivo):

72 h
Reading time points: 1, 6, 24, 48 and for 1 animal at 72 hours

Number of animals or in vitro replicates:

4

Details on study design:

SCORING SYSTEM: according to 79/831/EWG, Annex, Part B (Draize scoring system)

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

mean out of all 4 animals

Time point:

other: mean over 24, 48 and 72 h

Score:

0

Max. score:

4

Reversibility:

other: Reversibility: not applicable

Remarks on result:

other: no 72 h data are available for 3 animals; for calculation of mean scores, the 72 h values were assumed to be the same as those at 48 h (worst case assumption: persistence of effects seen at 48 h over 72 h)

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

mean out of all 4 animals

Time point:

other: mean over 24, 48 and 72 h

Score:

0

Max. score:

2

Reversibility:

other: Reversibility: not applicable

Remarks on result:

other: no 72 h data are available for 3 animals; for calculation of mean scores, the 72 h values were assumed to be the same as those at 48 h (worst case assumption: persistence of effects seen at 48 h over 72 h)

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

mean out of all 4 animals

Time point:

other: mean over 24, 48 and 72 h

Score:

0

Max. score:

3

Reversibility:

other: Reversibility: not applicable

Remarks on result:

other: no 72 h data are available for 3 animals; for calculation of mean scores, the 72 h values were assumed to be the same as those at 48 h (worst case assumption: persistence of effects seen at 48 h over 72 h)

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

mean out of all 4 animals

Time point:

other: mean over 24, 48 and 72 h

Score:

0

Max. score:

4

Reversibility:

other: Reversibility: not applicable

Remarks on result:

other: no 72 h data are available for 3 animals; for calculation of mean scores, the 72 h values were assumed to be the same as those at 48 h (worst case assumption: persistence of effects seen at 48 h over 72 h)

Irritant / corrosive response data:

No reactions were observed on the cornea and the iris.
The conjunctival reactions were slight to moderate in 2 of 4 animals at reading time point 1 and 6 hour and disappeared totally within 24 hours after application.

Any other information on results incl. tables

Table 1: Evaluation of the eye lesions

Rabbit No.	Scoring [h]	Cornea	Iris	Conjunctiva
				Redness	Chemosis
1	1	0	0	0	0
	6	0	0	0	0
	24	0	0	0	0
	48	0	0	0	0
	72	0	0	0	0
Mean (24, 48, 72 h)		0	0	0	0
2	1	0	0	1	0
	6	0	0	1	0
	24	0	0	0	0
	48	0	0	0	0
	72	No experimental data available; for calculation of mean scores, the 72 h values were assumed to be the same as those at 48 h (worst case assumption)
Mean (24, 48, 72 h)		0	0	0	0
3	1	0	0	1	0
	6	0	0	1	0
	24	0	0	0	0
	48	0	0	0	0
	72	No experimental data available; for calculation of mean scores, the 72 h values were assumed to be the same as those at 48 h (worst case assumption)
Mean (24, 48, 72 h)		0	0	0	0
4	1	0	0	0	0
	6	0	0	0	0
	24	0	0	0	0
	48	0	0	0	0
	72	No experimental data available; for calculation of mean scores, the 72 h values were assumed to be the same as those at 48 h (worst case assumption)
Mean (24, 48, 72 h)		0	0	0	0
Group mean		0	0	0	0

- = Not evaluated

 

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: not classified
DSD: not classified