p-tolyl 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:

secondary literature

Justification for type of information:

Data is from ECETOC reports

Data source

Reference

Reference Type:

secondary source

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 n-butyl acetate

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

N-butyl acetate

EC Number:

204-658-1

EC Name:

N-butyl acetate

Cas Number:

123-86-4

Molecular formula:

C6H12O2

IUPAC Name:

N-butyl acetate

Test material form:

liquid

Details on test material:

- Name of test material (as cited in study report):1-Butyl acetate
- Molecular formula: C6H12O2
- Molecular weight: 116.159 g/mol
- Substance type: Organic
- Physical state: Liquid
- Smiles: O(CCCC)C(C)=O
- InChI: 1S/C6H12O2/c1-3-4-5-8-6(2)7/h3-5H2,1-2H3

Specific details on test material used for the study:

Name of test material (as cited in study report):n-butyl acetate
- Molecular formula : C6H12O2
- Molecular weight : 116.160 g/mol
- Substance type: Organic
- Physical state: Liquid
- Purity: 99%, purchased from Fischer

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 and 7 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:

7.5

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:

7 d

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

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	0	-
	Area involved	B	1	0	0	0	0	-
	(A*B)*5		5	0	0	0	0	-
Iris		C	0	0	0	0	0	-
	C*5		0	0	0	0	0	-
Conjunctiva	Redness	D	1	1	1	1	0	-
	Chemosis	E	1	0	0	0	0	-
	Discharge	F	1	0	0	0	0	-
	(D+E+F)*2		6	2	2	2	0	-
Total			11	2	2	2	0	-

 

Applicant's summary and conclusion

Interpretation of results:

other: not irritating

Conclusions:

The MMAS (Maximum Modified Average Score) of n-butyl acetate was 7.5 after 1 day of observation.
Based on the classification of chemicals according to MMAS scores n-butyl 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 n-butyl acetate.

0.1 ml of n-butyl 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 n-butyl acetate was 7.5 after 1 day of observation. The effects were recovered fully after 7 days and the MMAS scores were 0.0.

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