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Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
other: Méthode B5 de la Directive de la Commission 2004/73/CE.
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Details on test material:
- Name of test material (as cited in study report): GASIR1
- Physical state: red solid
- test material was ground using a Retsch Centrifugal Ball Mill and passed through a 250 µm sieve before use.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: David Perceval Ltd, Moston; Sandbach, Cheshire, UK
- Age at study initiation:12-20 weeks
- Weight at study initiation:2-3.5kg
- Housing: individually in suspended cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period:5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23°C
- Humidity (%): 30-70%
- Air changes (per hr):15
- Photoperiod (hrs dark / hrs light): 12hrs dark/12hrs light

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: In one animal, one eye was treated, the other was the control
Amount / concentration applied:
100mg
Duration of treatment / exposure:
72h
Observation period (in vivo):
72h
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 1 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 1 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 1 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 1 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 1 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 1 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 1h
Score:
1
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24 h
Score:
1
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 48h, 72h
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 1h
Score:
1
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24 h
Score:
1
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
48 h
Score:
1
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
72 h
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 1h
Score:
1
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24 h
Score:
1
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
48 h
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
72 h
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 1 h
Score:
1
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 1 h
Score:
1
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 1 h
Score:
1
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 3 days
Other effects:
Dark red-coloured residual test material was noted in all treated eyes at the 1-hour observation and in one treated eye at the 24-hour observation.
Dark red-coloured staining of the fur was noted around all treated eyes during the study.


Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
According to the CLP regulation the classification criteria for eye irritation applicable to the OECD 405 test data (Table 3.3.2) are not met
Conclusions:
The test material produced a maximum group mean score of 6.0 and was classified as a MILD IRRITANT (CLASS 4 ON A 1 TO 8 SCALE) to the rabbit eye according to a modified Kay and Calandra classification system.

According to the CLP regulation, the classification criteria for eye irritation applicable to the OECD 405 test data (Table 3.3.2) are not met

 
  
Executive summary:

Introduction. The study was performed to assess the irritancy potential of the test material to the eye of the New Zealand White rabbit. The method was designed to meet the requirements of the following:

  • OECD Guidelines for the Testing of Chemicals No. 405 “Acute Eye Irritation/Corrosion” (adopted 24 April 2002)
  • Method B5 Acute Toxicity (Eye Irritation) of Commission Directive 2004/73/EC

Result. A single application of the test material to the non-irrigated eye of three rabbits produced minimal conjunctival irritation. Two treated eyes appeared normal at the 48-hour observation and the remaining treated eye appeared normal at the 72-hour observation.

Conclusion.

The test material produced a maximum group mean score of 6.0 and was classified as a mild irritant (Class 4 on a 1 to 8 scale) to the rabbit eye according to a modified

Kay and Calandra classification system.

According to the CLP regulation, the classification criteria for eye irritation applicable to the OECD 405 test data (Table 3.3.2) are not met

 

Table 3.3 2Eye irritation

Category

Criteria

Category 2

 

Substances that produce in at least in 2 of 3 tested animals, a positive

response of:

(a) corneal opacity≥1 and/or

(b) iritis ≥ 1, and/or

(c) conjunctival redness ≥ 2 and/or

(d) conjunctival oedema (chemosis) ≥ 2

calculated as the mean scores following grading at 24, 48 and 72 hours after installation of the test material, and which fully reverses within an observation period of 21 days