3-methoxybutyl acetate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP compliant, guideline study, available as unpublished report, no restrictions, fully adequate for assessment

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1997

Reference 2

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

3-methoxybutyl acetate

EC Number:

224-644-9

EC Name:

3-methoxybutyl acetate

Cas Number:

4435-53-4

Molecular formula:

C7H14O3

IUPAC Name:

3-methoxybutyl acetate

Constituent 2

Reference substance name:

butoxyl rein 98/100%

IUPAC Name:

butoxyl rein 98/100%

Details on test material:

- Name of test material (as cited in study report): Butoxyl rein 98/100%
- Physical state: Colourless clear fluid
- Analytical purity: 99.7%
- Purity test date: 8 November 1991
- Lot/batch No.: production date 21 August 1991
- Stability under test conditions: 5 years
- Storage condition of test material: darkness at room temperature in fume cupboard

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: HOESCHT AG, Kastengrund
- Age at study initiation: 3-5 months
- Weight at study initiation: 3.1-3.8 kg
- Housing: Individually
- Diet: Altromin 2123 ad libitum and approximately 15 g of hay per day.
- Water: ad libitum
- Acclimation period: not reported

ENVIRONMENTAL CONDITIONS
- Temperature: 18±3°C
- Humidity: 55±20%
- Air changes (per hr): not reported
- Photoperiod: 12 hrs dark / 12 hrs light

IN-LIFE DATES: From: 29 October 1991 To: 8 November 1991

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated right eye served as a control

Amount / concentration applied:

0.1 mL

Duration of treatment / exposure:

single instillation

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with isotonic saline at approx 37°C
- Time after start of exposure: 24 hours and at any other designated examination time if discharge present in treated eye or at which corneal examination with fluorescein took place.

SCORING SYSTEM: Corneal opacity on a 0-4 scale, iritis on a 0-2 scale, conjunctival redness and discharge on a 0-3 scale, conjunctival chemosis on a 0-4 scale

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

other: Scores of zero at 1, 24, 48, and 72 hr

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

other: Scores of zero at 1, 24, 48, and 72 hr

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

other: Scores of zero at 1, 24, 48, and 72 hr

Results 4

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

other: Sxores of zero at 1, 24, 48 and 72 hr

Results 5

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

other: Sxores of zero at 1, 24, 48 and 72 hr

Results 6

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

other: Sxores of zero at 1, 24, 48 and 72 hr

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.3

Max. score:

1

Reversibility:

fully reversible within: 48 hr

Remarks on result:

probability of weak irritation

Remarks:

score of 1 at 24 hr. Zero at 48 and 72 hr

Results 8

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.7

Max. score:

2

Reversibility:

fully reversible within: 48 hr

Remarks on result:

other:

Remarks:

score of 2 at 24 hr. Zero at 48 and 72 hr

Results 9

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.7

Max. score:

2

Remarks on result:

other:

Remarks:

score of 2 at 24 hr. Zero at 48 and 72 hr.

Results 10

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

other: scores of zero at 24, 48 and 72 hr

Results 11

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

other: scores of zero at 24, 48 and 72 hr

Results 12

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

other:

Remarks:

scores of zero at 24, 48 and 72 hr

Irritant / corrosive response data:

1 and 24 hours after administration, the conjunctivae of the animals showed definitely injected blood vessels up to a diffuse crimson red colour as well as slight swellings up to swellings with lids about half closed. Additionally clear colourless eye discharge was noted. 2 days after administration all signs had cleared.

Any other information on results incl. tables

Eye irritation scores of butoxyl rein 98/100%

Time	Cornea			Iris			Conjunctiva
							Redness			Chemosis
Animal number	54	55	56	54	55	56	54	55	56	54	55	56
after 1 hour	0	0	0	0	0	0	2	2	2	2	3	1
after 24 hours	0	0	0	0	0	0	1	2	2	0	0	0
after 48 hours	0	0	0	0	0	0	0	0	0	0	0	0
after 72 hours	0	0	0	0	0	0	0	0	0	0	0	0
mean scores 24-72h	0	0	0	0	0	0	0.3	0.7	0.7	0	0	0

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Butoxyl (98% purity) is not irritant to eyes.

Executive summary:

The eye irritancy potential of butoxyl (purity 98%) was assessed in 3 rabbits according to OECD guideline 405. The initial pain reaction was assessed and eyes were irrigated 24 hours after dosing. The ocular reaction was assessed according to the numerical scoring system at approximately 1, 24, 48 and 72 hours after application.

Mean scores for corneal opacity, iridial effects and chemosis were 0.00 and the mean score for conjunctival redness was 0.55.

Butoxyl was considered to be not irritating to the rabbit eye.