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:
25 May 1995 to 28 July 1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report Date:
1995

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Specific details on test material used for the study:
Betadet SHR
Lot number: 7049
pH 7.48
Appearance: viscous yellowish liquid
Storage: Room temperature protected from light

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Three New Zealand White male rabbits were used.
Weight on receipt: 2.0-2.2 kg
Age on receipt: approximately 9-10 weeks
Source: B and K Universal G.J., S.L.
Housing: Individually in stainless steel cages with a grill floor
Acclimatisation period: seven days
Weight at administration of test substance: 2.2-2.4 kg
Temperature: 18-22 degrees C
Humidity: 50-85%
Photoperiod: 12 hour dark/light cycle
Diet: Standard rabbit diet UAR 112, supplied by PANLAB, S. L., ad libitum
Water: Supplied by Compañia de Aguas de Sabadell, ad libitum

Test system

Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
21 days after treatment
Duration of post- treatment incubation (in vitro):
.
Number of animals or in vitro replicates:
Three
Details on study design:
Following administration of the test substance, the eyelids were held closed for approximately 10 seconds. The behaviour of the animals was observed following instillation of the test substance. The animals were then returned to their cages.

The degree of eye irritation as evaluated for each rabbit at 1, 24, 48 and 72 hours after treatment. Additional observations were made on Days 7, 14 and 21 after treatment to check the reversibility of the reactions.

Observations were made after applying 2% aqueous sodium fluorescein to test the area and washing with physiological saline, with the exception of the 1 hour observations. Corneal alterations were made with the aid of a transilluminator with a cobalt blue filter.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 21 days
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 14 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
2.78
Max. score:
3
Reversibility:
fully reversible within: 21 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
1.89
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Remarks:
Reversible in two rabbits; findings persisted (grade 1) to 21 days in one rabbit

Any other information on results incl. tables

Eye irritation scores

 

60 minutes

24 hours

48 hours

72 hours

Mean (24-72 hours)

7 days

14 days

21 days

Cornea

0,0,0

1,1,1

1,1,1

1,1,1

1.00

1,0,0

1,0,0

0,0,0

Iris

1,1,1

1,1,1

1,1,1

1,1,1

1.00

1,1,0

0,0,0

0,0,0

Erythema

3,2,2

3,3,3

3,3,3

2,3,2

2.78

1,2,1

0,1,1

0,0,0

Chemosis

2,3,2

2,3,2

1,2,2

1,2,2

1.89

1,1,1

1,0,1

0,0,1

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
Instillation of the submission substance into the eyes of three rabbits caused marked eye irritation (corneal opacity, iridial infllammation, conjunctival erythema and chemosis). Irritation was reversible in two rabbits but persisted (grade 1 conjunctival chemosis only) in one rabbit at 21 days.
Executive summary:

The submission substance Betadet SHR was instilled (0.1 mL) into one eye of three New Zealand White rabbits in accordance with OECD TG 405. Ocular irritation was scored for up to 21 days after instillation, using the Draize scale. Signs of irritation included corneal opacity (Grade 1 in all animals, fully reversible by 21 days); iridial inflammation (Grade 1 in all animals, fully reversible by 14 days); conjunctival erythema (Grade 3 in all animals, fully reversible by Day 21); and conjunctival chemosis (Grade 2-3). Grade 1 conjunctival chemosis persisted in one rabbit at 21 days. The mean scores for corneal opacity (mean score ≥1), iridial inflammation (mean score ≥1) and conjunctival erythema (mean score ≥2) result in classification of the substance as a Category 2 eye irritant according to the CLP Regulation; however the lack of complete reversibility of conjunctival chemosis in one rabbit at 21 days triggers classification in Category 1.