3-methoxybutan-1-ol

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other: GLP compliant, guideline study, available as unpublished report, no restrictions, fully adequate for assessment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

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

not specified

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

not specified

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3-methoxybutan-1-ol

EC Number:

219-741-8

EC Name:

3-methoxybutan-1-ol

Cas Number:

2517-43-3

Molecular formula:

C5H12O2

IUPAC Name:

3-methoxybutan-1-ol

Constituent 2

Reference substance name:

methoxybutanol

IUPAC Name:

methoxybutanol

Details on test material:

- Name of test material (as cited in study report): methoxybutanol
- Physical state: clear, colourless liquid
- Analytical purity: 99.5%
- Lot/batch No.: Hoe CG 0388 0A ZD00 0001
- Expiration date of the lot/batch: August 1996
- pH in water: 7
- Storage condition of test material: in the dark at room temperature in fume cupbaord

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Hoechst AG, Kastengrund, SPF Zucht
- Age at study initiation: 3-5 months
- Weight at study initiation: 2.5-3.8 kg
- Fasting period before study: no
- Housing: Individually
- Diet: Altromin 2123 ad libitum (approximately 15 g/day)
- Water: ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature: 18±3°C
- Humidity: 55±20%
- Air changes (per hr): no data
- Photoperiod: 12 hrs dark / 12 hrs light):

IN-LIFE DATES: From: 22 October to 1 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 application

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): YES 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: According to OECD guidelines (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 (under ultraviolet light)

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:

4

Remarks on result:

other: No opacity at any time point

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: No opacity at any time point

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Remarks on result:

other: 0.3 is average of 24/72/48 hr time points. A score of 1 was observed at 24 hrs and zero at ohter time points

Results 4

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Remarks:

score of zero at all time points

Results 5

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Remarks:

Score of zero at all time points

Results 6

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 hr

Remarks on result:

probability of weak irritation

Remarks:

Score of 1 at 24 hr and zero at ohter time points

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72 hr

Remarks on result:

probability of weak irritation

Remarks:

redness scores of 2, 1, 0 at 24, 48 and 72 hr, respectivley.

Results 8

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.7

Max. score:

4

Reversibility:

fully reversible within: 48 hr

Remarks on result:

probability of weak irritation

Remarks:

redness scores of 2, 0, 0 at 24, 48 and 72 hr, respectively

Results 9

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72 hr

Remarks on result:

probability of weak irritation

Remarks:

redness score of 2 and 1 at 24 and 48 hr. Zero at 72 hr.

Results 10

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.7

Max. score:

4

Reversibility:

fully reversible within: 72 hr

Remarks on result:

probability of weak irritation

Remarks:

scores of 1 at both 24 and 48 hr. Zero at 72 hr

Results 11

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 24 hr

Remarks on result:

probability of weak irritation

Remarks:

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

Results 12

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.7

Max. score:

4

Reversibility:

fully reversible within: 48 hr

Remarks on result:

probability of weak irritation

Remarks:

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

Irritant / corrosive response data:

On rabbit had slight corneal opacity (score of 1) and slight iritis (score of 1) at the 24 hour reading only. There was no corneal or iridial involvement in the remaining animals. Slight or moderate conjunctival redness was present in all rabbits at the 1 hour, 1 day and 2 day readings. Very slight / slight conjunctival chemosis was present in all rabbits at the 1 hour and day 1 reading and in one rabbit at the 2 day reading. A clear colourless discharge was present in the treated eye of all 3 rabbits at the 1 hour reading which persisted until the day 1 reading in one rabbit. A white/yellow viscous discharge and reddened iris was seen in another rabbit at the day 1 reading but this did not persist.

Other effects:

none

Any other information on results incl. tables

Eye irritation scores of 3-methoxybutanol

Time	Cornea			Iris			Conjunctiva
							Redness			Chemosis
Animal number	8	65	67	8	65	67	8	65	67	8	65	67
after 1 hour	0	0	0	0	0	0	2	2	2	1	1	2
after 24 hours	0	0	1	0	0	1	2	2	2	1	1	2
after 48 hours	0	0	0	0	0	0	1	0	1	1	0	0
after 72 hours	0	0	0	0	0	0	0	0	0	0	0	0
mean scores 24-72h	0	0	0.3	0	0	0.3	1.0	0.7	1.0	0.7	0.3	0.7

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Methoxybutanol was slightly irritating to the rabbit eye.

Executive summary:

Methoxybutanol was slightly irritating to the rabbit eye.