Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1990
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted May 12, 1981
Deviations:
no
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Dr. K. Thomae GMBH, Chemisch-pharmazeutische Fabrik, Biberach/Riss, Germany
- Animal strain in detail: Chbb:NZW
- Age at study initiation: approx. 9-13 weeks old
- Weight at study initiation: 2290 to 2490 g
- Housing: individually
- Diet: standard rabbit pellet - Nafag No. 814, Gossau, Switzerland, ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The right eye remained untreated and served as a control.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml (32 mg) was placed into the conjunctival sac of the left eye of each animal, after gently pulling away the lower lid from the eyeball. The lids were then held together for about one second in order to prevent loss of the test article.
Duration of treatment / exposure:
single application

Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3 females
Details on study design:
SCORING SYSTEM: Draize system

- Scoring time: The ocular reactions were evaluated 1, 24, 48, and 72 hours after the instillation of the test item

TOOL USED TO ASSESS SCORE: slit lamp

OTHER:
- The animals were checked daily for systemic symptoms and mortality.
- Bodyweight was recorded at study initiation and on days 3 and 7 of the observation period.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritation parameter:
iris score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
2
Reversibility:
other: reversibility: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: mean over 24, 48 and 72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: mean over 24, 48 and 72 h
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritant / corrosive response data:
Slight conjunctivae redness (grade 1) seen at reading time points 1 hour up to 72 hours in 2/3 animals was reversible within 7 days after application. The average score (24, 48 and 72 hours) for irritation was calculated to be 1.0 (for conjunctivae redness). Slight, reversible conjunctivae redness (grade 1) was noted in the third animal 1 hour to 48 hours after application, fully reversible within 72 hours. Chemosis (grade 1) was observed in 3/3 animals one hour after treatment, only.
Other effects:
No other findings were observed.

Any other information on results incl. tables

Table 1. Results of eye irritation study.

Rabbit #

 

Time

conjunctivae

iris

cornea

redness

chemosis

1

 

 

 

 

1 h

1

1

0

0

24 h

1

0

0

0

48 h

1

0

0

0

72 h

1

0

0

0

7 d

0

0

0

0

average over 24, 48 and 72 h

1.0

0.0

0.0

0.0

2

 

 

 

 

1

1

1

0

0

24 h

1

0

0

0

48 h

1

0

0

0

72 h

1

0

0

0

7 d

0

0

0

0

average over 24, 48 and 72 h

0.0

0.0

0.0

0.0

3

 

 

 

 

1

1

1

0

0

24 h

1

0

0

0

48 h

1

0

0

0

72 h

0

0

0

0

7 d

0

0

0

0

average over 24, 48 and 72 h

0.67

0.0

0.0

0.0

 

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Oxybenzone was found to be slightly irritating to rabbit eyes, fully reversible within 7 days, in this test but does not require classification according to CLP and/or DSD.
Executive summary:

Slight conjunctivae redness (grade 1) observed at reading time points 1 hour up to 72 hours in 2/3 animals was reversible within 7 days after application. The average score (24, 48 and 72 hours) for irritation was calculated to be 1.0 (for conjunctivae redness). Slight, reversible conjunctivae redness(grade 1) was noted in the third animal 1 to 48 hours after application.Therefore, average score (24, 48 and 72 hours) for irritation was calculated to be 0.67 (for conjunctivae redness) for this animal. For corneal opacity, iris and chemosis the average score (24, 48 and 72 hours) for irritation was calculated to be 0.0.The eye irritation study is acceptable (reliability 1), and does satisfy the guideline requirements for an eye irritation test (OECD 405) in rabbits.

Under the experimental conditions chosen, the test substance was considered to be not irritating to the eye of rabbits.Therefore, the test item is not warranted to be classified according to the EU Directive 67/548/EC and according to the CLP Regulation 1272/2008.