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Diss Factsheets

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The study was conducted in compliance with OECD test guideline number 405 and OECD Good Laboratory Practice Standards and is considered "reliable without restriction" according to the criteria of Klimisch, 1997, when used to evalute the tested substance. However, because the study is being used as read-across to evaluate a similar substance, the reliability of the study is reduced to "reliable with restrictions".

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report date:
1997

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Reference substance name:
Reference substance 001
Cas Number:
115733-09-0
Molecular formula:
Not available for UVCB substances

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: E.S.D. (Romans, 01400 Chatillon-sur-Chalaronne, France)
- Age at study initiation: Adult (3 months old)
- Weight at study initiation: 2 to 3 kg.
- Housing: In an air-conditioned building
- Diet (e.g. ad libitum): About 150 g/animal/day of pelleted complete rabbit diet (Diet reference 112 C-10 -Usine d'Alimentation Rationnelle. Villemoisson, 91360 Epinay-sur-Orge, France), sterilised by irradiation and analysed for the absence of chemical and bacterial contaminants.
- Water (e.g. ad libitum): Softened and filtered drinking water, ad libitum analyzed at least once a year for chemical contaminants and at least twice a year for bacterial contaminants.
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 ± 3°C
- Humidity (%): > or = 45 %
- Air changes (per hr): Minimum 12 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours light (artificial) 12 hours dark

IN-LIFE DATES: From: To:

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: left eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): 100%

VEHICLE
- Amount(s) applied (volume or weight with unit): None
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity:
Duration of treatment / exposure:
Two groups of animals were observed (group 1 and group 2). After administration of the test article, the lower and upper eyelids were held in contact for 30 seconds in both groups to prevent loss of substance ; after this time the eyes were rinsed in group 2, for 30 seconds with tepid tap water.
Observation period (in vivo):
The ocular examinations were performed in the conjunctiva, iris and cornea, according to a numerical scale, 1 hour after administration of the test article, then at 24 (day 1), 48 and 72 hours. In addition, taking into account the lesions observed at 72 hours and in order to reveal a possible reversibility, these readings were continued on day 7.
Number of animals or in vitro replicates:
Total of 9. Two groups of animals: group 1 (6 treated rabbits, non-rinsed) and group 2 (3 treated rabbits, rinsed).
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Two groups of animals were treated. Group 1 :Non-rinsed; Group 2 : Rinsed
- Time after start of exposure: Group 2: after 30 seconds

SCORING SYSTEM:

TOOL USED TO ASSESS SCORE: Bright lights and fluorescein.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, and 72 hours
Score:
1.56
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: Group 1 (non-rinsed)
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, and 72 hours
Score:
1.67
Max. score:
3
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: Group 1 (non-rinsed)
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, and 72 hours
Score:
0.06
Max. score:
2
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: Group 1 (non-rinsed)
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 hours
Score:
0
Max. score:
4
Remarks on result:
other: Group 1 (non-rinsed)
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, and 72 hours
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: Group 2 (rinsed)
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, and 72 hours
Score:
0.78
Max. score:
3
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: Group 2 (rinsed)
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 hours
Score:
0
Max. score:
2
Remarks on result:
other: Group 2 (rinsed)
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 hours
Score:
0
Max. score:
4
Remarks on result:
other: Group 2 (rinsed)
Irritant / corrosive response data:
Group 1 (non-rinsed) : From the results obtained under the experimental conditions employed, application of this test article to the eye (non-rinsed) of the rabbit provoked a slight irritation. Group 2 (rinsed) : From the results obtained under the experimental conditions employed, application of this test article to the eye (rinsed) of the rabbit provoked a mild irritation.
Other effects:
No mortality was observed during the study.

Applicant's summary and conclusion

Interpretation of results:
other: not classified
Remarks:
Criteria used for interpretation of results: OECD GHS
Conclusions:
Group 1 (non-rinsed) : From the results obtained under the experimental conditions employed, application of this test article to the eye (non-rinsed) of the rabbit provoked a slight irritation. Group 2 (rinsed) : From the results obtained under the experimental conditions employed, application of this test article to the eye (rinsed) of the rabbit provoked a mild irritation. According to GHS guidelines, this test article is not classified.
Executive summary:

PROTOCOL

The test article was administered as supplied and at the dose level of 0.1 ml per animal, into the inferior conjunctival sac of the right eye of treated New Zealand White male rabbits (supplier: E.S.D. - body weights: 2.34 to 2.78 kg). Two groups of animals were observed comparatively: Group 1 : 6 treated rabbits, non-rinsed and Group 2 : 3 treated rabbits, rinsed.

After administration of the test article, the lower and upper eyelids were held in contact for 30 seconds in both groups to prevent loss of substance ; after this time the eyes were rinsed in group 2, for 30 seconds with tepid tap water.

The ocular examinations were performed in the conjunctiva, iris and cornea, according to a numerical scale, 1 hour after administration of the test article, then at 24 (day 1), 48 and 72 hours. In addition, taking into account the lesions observed at 72 hours and in order to reveal a possible reversibility, these readings were continued on day 7. These examinations were performed using a bright light placed in front of the rabbit's eyes.

Examinations for morbidity/mortality were performed twice daily, at the beginning and at the end of the working day.

The animals were weighed on the day of dosing.

Mean values were calculated from the evaluation of the ocular lesions performed for the 6 rabbits (group 1) or for each rabbit (group 2) examined at 24, 48 and 72 hours.

RESULTS

No mortality was observed during the study. Group 1 (non-rinsed) : a global average (24 hours + 48 hours + 72 hours) of 1. 56 for chemosis to conjunctiva, 1.67 for redness to conjunctiva, 0.06 for congestion to iris, and 0.00 for degree of opacity to cornea. The lesions observed at 72 hours showed a total reversibility in the 6 rabbits examined on day 7. Group 2 (rinsed) : a global average (24 hours + 48 hours + 72 hours) of 0.33 for chemosis to conjunctiva, 0.78 for redness to conjunctiva, 0.00 for congestion to iris, and 0.00 for degree of opacity to cornea. The lesions observed at 72 hours showed a total reversibility in the rabbits examined on

day 7.

CONCLUSION

Group 1 (non-rinsed) : From the results obtained under the experimental conditions employed, application of this test article to the eye (non-rinsed) of the rabbit provoked a slight irritation. According to the guide to the labelling of dangerous substances published in the Official Journal of the European Communities (EEC Directive 93/21), this test article can be labelled as follows:

Symbol: nothing

Risk sentence: nothing

Group 2 (rinsed) : From the results obtained under the experimental conditions employed, application of this test article to the eye (rinsed) of the rabbit provoked a mild irritation. The irritation observed in non-rinsed eyes was slightly higher than that observed in the eyes after rinsing.