Octyl acetate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: data from ECETOC reports

Data source

Reference

Reference Type:

review article or handbook

Title:

Eye Irritation- Reference Chemicals data bank (Second Edition)

Author:

ECETOC

Year:

1998

Bibliographic source:

ECETOC Technical Report no. 48 (2), 1998

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Principles of method if other than guideline:

An eye irritation study was carried out according to OECD 405 “EYE IRRITATION” to evaluate the irritation potential of the test chemical

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Ethyl acetate

EC Number:

205-500-4

EC Name:

Ethyl acetate

Cas Number:

141-78-6

IUPAC Name:

ethyl acetate

Test material form:

other: liquid

Details on test material:

Name of test material (as cited in study report):ethyl acetate
- Molecular formula : C4H8O2
- Molecular weight : 88.11g/mol
- Substance type: Organic
- Physical state: Liquid

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

no data

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

0.1 ml

Duration of treatment / exposure:

single instillation

Observation period (in vivo):

Observations were made after 1 hour, 4 hours and then 1,2,3 days after instillation of test chemical

Number of animals or in vitro replicates:

4 rabbits

Details on study design:

TEST SITE
- Area of exposure: conjunctival sac

SCORING SYSTEM: According to the Draize method
Grading Scale for Eye Irritation:
Cornea Grade
Opacity: degree of density (readings should be taken from most dense area)*
No ulceration or opacity = 0
Scattered or diffuse areas of opacity (other than slight dulling of normal lustre); details of iris slightly obscured = 1
Easily discernible translucent area; details of iris slightly obscured = 2
Opalescent area; no details of iris visible; size of pupil barely discernible = 3
Opaque cornea; iris not discernible through the opacity = 4
Iris
Normal = 0
Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia; or injection; iris reactive to light (a sluggish reaction is considered to be an effect = 1
Hemorrhage, gross destruction, or no reaction to light = 2
Maximum possible: 2
Conjunctivae
Redness (refers to palpebral and bulbar conjunctivae; excluding cornea and iris)
Vessels Normal = 0
Vessels definitely injected above normal = 1
Diffuse, crimson colour; individual vessels not easily discernible = 2
Diffuse beefy red = 3
Chemosis
Swelling (refers to lids and/or nictating membranes)
Normal = 0
Any swelling above normal (includes nictating membrane)= 1
Obvious swelling, with partial eversion of lids = 2
Swelling, with lids about half closed = 3
Swelling, with lids more than half closed= 4

Overall Maximum Possible Score = 110

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

other: Modified Maximum Average Score

Basis:

mean

Time point:

other: 1 days

Score:

15

Max. score:

110

Reversibility:

fully reversible

Remarks:

7 days

Remarks on result:

other: Conjunctival redness and chemosis was observed in all animals after 1 day of observation

Results 2

Irritation parameter:

other: Modified Maximum Average Score

Basis:

mean

Time point:

other: 7 days

Score:

0

Max. score:

110

Remarks on result:

other: no effects observed

Irritant / corrosive response data:

Conjunctival redness and chemosis was observed in all animals after 1 day of observation. The effects were fully recovered by 7 days

Any other information on results incl. tables

Table 1: Draize scores for animal 2

Area	Effects		Observation period (days)
			1	2	3	7	14	21
Cornea	Opacity	A	1	0	0	0	-	-
	Area involved	B	1	0	0	0	-	-
	(A*B)*5		5	0	0	0	-	-
Iris		C	1	0	0	0	-	-
	C*5		5	0	0	0	-	-
Conjunctiva	Redness	D	2	1	1	0	-	-
	Chemosis	E	1	1	0	0	-	-
	Discharge	F	1	0	0	0	-	-
	(D+E+F)*2		8	4	2	0	-	-
Total			18	4	2	0	-	-

 

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The MMAS (Maximum Modified Average Score) of ethyl acetate was 15.0 after 1 day of observation.
Based on the classification of chemicals according to MMAS scores ethyl acetate can be considered to be not irritating to rabbit eyes.

Executive summary:

An eye irritation study was carried out according to OECD 405 “EYE IRRITATION” to evaluate the irritation potential of the test chemical.

0.1 ml of ethyl acetate was instilled into the conjunctival sac of 4 New Zealand White rabbits. Observations were made after 1 hour, 4 hours and then 1, 2, 3 and 7 days after instillation of test chemical.The scoring was done according to the Draize method.Conjunctival redness and chemosis was observed in all animals after 1 day of observation. The MMAS (Maximum Modified Average Score) of ethyl acetate was 15.0 after 1 day of observation. The effects were fully recovered after 7 days and the MMAS scores was 0.0 for all rabbits.

Based on the classification of chemicals according to MMAS scores, ethyl acetate can be considered to be not irritating to rabbit eyes.