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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1984
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report Date:
1984

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
equivalent or similar to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Ethoxypropanol
- Physical state: Liquid
- Analytical purity: 91.1%
- Impurities (identity and concentrations):
8.0% 2-ethoxy-1-propanol
0.7% 1-methoxy-2-propanol
0.1% 2-methoxy-1-propanol
0.04% 1-(2-propenyloxy)-2-propanol
- Purity test date: 6 June 1983
- Lot/batch No.: Batch No. 96 from BP Chemie, Lavera
- Storage condition of test material: In the dark at room temperature

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Each animal was uniquely identified by an ear tattoo.

TEST ANIMALS
- Source: Ranch Rabbits, Crawley Down, Sussex, England
- Weight at study initiation: 2.2 – 2.6 kg
- Housing: Individually in aluminium cages with grid floors.
- Diet: Ad libitum access to Guinea Pig Maintenance Diet from Special Diet Services, Witham, Essex.
- Water: Ad libitum access to water supplied by the North Surrey Water Company
- Acclimation period: 8 days

ENVIRONMENTAL CONDITIONS
- Temperature: 18 - 22 degrees C
- Humidity: 42 - 59 % relative humidity
- Photoperiod: 12-hour light: 12-hour dark cycle

IN-LIFE DATES: From: April 10, 1984 To: April 17, 1984

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The contralateral eye of each animal remained untreated and served as a control.
Amount / concentration applied:
TEST MATERIAL
- Concentration (if solution): 0.1 ml was placed into the lower lid of one eye of each animal.
Duration of treatment / exposure:
Single exposure
Observation period (in vivo):
The initial reaction of the animal was recorded. Examination of the eyes was made 1, 24, 48 and 72 hours and 7 days after instillation.
Number of animals or in vitro replicates:
Three
Details on study design:
SCORING SYSTEM: Draize et al, 1944. Any ocular reactions not adequately described by the scoring system were recorded in full.

TOOL USED TO ASSESS SCORE: Observation of the eyes was aided by the use of a handheld ophthalmoscope. Damage to the tissues of the eye was investigated by fluorescein staining at each observation.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
iris score
Basis:
mean
Time point:
other: Average of 24, 48, 72 hours
Score:
0
Max. score:
2
Reversibility:
other: no effects recorded
Remarks on result:
other: Effects in only two animals recorded. Corneal effects obscured observations in 3rd animal
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: Average of 24, 48, 72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: 2/3 rabbits affected
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: Average of 24, 48, 72 hours
Score:
0.67
Max. score:
3
Reversibility:
fully reversible
Remarks:
72 hours
Remarks on result:
other: 2/3 rabbits affected
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: Average of 24, 48, 72 hours
Score:
0.22
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: only 1/3 rabbits affected by 24hrs
Irritant / corrosive response data:
Damage to the surface of the cornea (Grade 2, with pitting noted, on a scale of 4) was visible in two animals. This resolved in both animals within 72 hours. Slight to moderate (Grade 1, 2) conjunctival redness was noted in these animals through 48 hours. Moderate to severe (Grade 2, 3-4) conjunctival chemosis was noted in these animals at 1 hour, and was resolved within 24 hours in the severe animal and reduced to Grade 1 at 24 and 48 hours in the second animal.

No corneal changes were noted in the third animal. This animal displayed mild (Grade 1) conjunctival redness and chemosis at 1 hour, after which the eye appeared normal.

No iris changes were seen in two of the animals. Corneal changes obscured observation in the third animal.

The animals evoked only slight immediate reactions (blinking, reflex eye closure) to administration of the test material.

Fluoroscein staining of the nictating membrane was seen up to 72 hours after exposure but was absent by day 7. Discharge was noted for up to 24 hours following exposure.

Any other information on results incl. tables

Data for individual animals

Animal #

Reaction

24 hours

48 hours

72 hours

7 days

1

CO

2#

2#

2

0

I

*

*

*

0

R

2

2

0

0

C

1

1

0

0

2

CO

2#

1#

0

0

I

0

0

0

0

R

1

1

0

0

C

0

0

0

0

3

CO

0

0

0

0

I

0

0

0

0

R

0

0

0

0

C

0

0

0

 0

Reaction: CO=Corneal Opacity, I=Iritis, R=Redness, C=Chemosis.

*=Details obscured by changes to cornea.

#=Pitting of corneal surface noted.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Ethoxypropanol was found to have the potential to cause irritation and corneal damage in the rabbit eye.
Executive summary:

In a GLP in vivo rabbit eye irritation study (unwashed), administration of 0.1 ml of ethyoxypropyl produced reversible corneal damage and conjuctival irritation.  These changes were resolved in all animals by Day 7. The responses were quite variable across the animals with one showing marked irritation and one negligible irritation.