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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline Study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
For reasons of animal welfare a sequential testing strategy was followed in accordance with the current version of the EEC Directive No. 440/2008 and the OECD Guideline No. 405, irrespective of the requirements of other guidelines for testing for eye irritation/corrosion in rabbits.
This testing strategy comprised a stepwise approach including the evaluation of existing human and/or animal data showing effects on the eye or the skin, the performance of a SAR evaluation for eye and skin corrosion/irritation, measurement of pH value, the evaluation of data on systemic toxicity via the dermal route, the performance of a validated in vitro test for skin corrosion (T 3081239, not corrosive), an in vitro test for skin irritation (T 2081238, not irritating) and an in vitro HET-CAM test for mucosal irritation hazard before in vivo testing for eye irritation/corrosion in rabbits.
The in vitro HET-CAM test is archived under T 5081240. The test compound is not irritating.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Molar mass: 166.13 g/mol, Content of test item*: 95 %, the dosing was based on the test item (used as 100%).
*due to product information given by the sponsor

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The other eye, which remained untreated, served as control.
Duration of treatment / exposure:
0.1 g of the pulverized test substance was placed into the conjunctival sac of one eye of the first animal after having gently pulled the lower lid away from the eyeball. The lids were gently held together for about one second in order to prevent loss of the test compound. The other eye, which remained untreated, served as control. The treated eye was rinsed 1 hour following instillation.
Because of the fact that one hour after treatment a severe irritation was observed in the first animal, only one further rabbit was treated as described.
Observation period (in vivo):
Eye irritations were scored and recorded approximately at 1, 24, 48 and 72 hours post application (in the following p.a.). If no irritation indices were observed after 72 h, the study was finished. If eye irritations were observed, animals were monitored usually on day 7, 14 and 21 after application until the changes had completely subsided, however for not more than 21 days after application.
Number of animals or in vitro replicates:
Two animals were used for the study.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24, 48, 72 h
Score:
3.3
Max. score:
4
Reversibility:
fully reversible within: 14 d
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24, 48, 72 h
Score:
0.5
Max. score:
2
Reversibility:
fully reversible within: 3d
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24, 48, 72 h
Score:
2.7
Max. score:
3
Reversibility:
fully reversible within: 7d
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24, 48, 72 h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 7d
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24, 48, 72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7d
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 24, 48, 72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 7d
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24, 48, 72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 7d
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24, 48, 72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 7d

Any other information on results incl. tables

Summary of Irritant Effects (Score)

Animal   Effect  24 h  48 h  72 h  Mean scores  Response  reversible (days)
 1  corneal opacity  4  3  3  3.3  ++  14
   iritis  *  1  0  0.5  -  3
   redness conjunctivae  2  3  3  2.7  +  7
   chemosis conjunctivae  2  2  2  2.0  +  7
 2   corneal opacity  2  2  2  2.0  +  7
   iritis  1  1  1  1.0  +  7
    redness conjunctivae  2  2  2  2.0  -  7
   chemosis conjunctivae  3  2  1  2.0  +  7

response:

corneal opacity: mean scores < 2 = -, = 2 < 3 = +, = 3 = ++

iritis: mean scores < 1 = -, = 1 < 2 = +, = 2 = ++

conjunctival redness: mean scores < 2.5 = -, = 2.5 = +

conjunctival oedema : mean scores < 2 = -, = 2 = +

* Iris not observable, therefore not to investigate.

Applicant's summary and conclusion

Executive summary:

The irritant / corrosive effects of the test substance were tested on the eye of female New Zealand White rabbits. The method used complied with the OECD - Guideline for Testing of Chemicals No. 405 -"Acute Eye Irritation/Corrosion"; adopted: 24th April 2002 and EEC Directive No. 440/2008 Part B - Method B.5. According to classification criteria the test substance causes serious damage to eyes with full reversibility within 14 days. There were no systemic intolerance reactions.