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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Remarks:
The study has been conducted according to guideline OECD TG 405.
Type of information:
experimental study
Adequacy of study:
key study
Study period:
between 26 August 2008 and 04 September 2008.
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report Date:
2008

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
Date of inspection: 21/08/2007 Date of signature: 15/10/07

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material: Oxooil LS9
- Physical state: clear colourless liquid
- Storage condition of test material: room temperature in the dark

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source:
Harlan UK Limited, Bicester, Oxon, UK

- Age at study initiation:
twelve to twenty weeks old

- Weight at study initiation:
At the start of the study the animals were in the weight range of 2.0 to 3.5 kg

- Housing:
The animals were individually housed in suspended cages

- Diet (e.g. ad libitum):
Free access to food (2030 Teklad Global Rabbit diet supplied by Harlan Teklad, Blackthorn, Bicester, Oxon, UK) was allowed throughout the study

- Water (e.g. ad libitum):
Free access to mains drinking water was allowed throughout the study

- Acclimation period:
at least five days


ENVIRONMENTAL CONDITIONS
- Temperature (°C):
The temperature awas set to achieve limits of 17 to 23°C

- Humidity (%):
The relative humidity was set to achieve limits of 30 to 70%

- Air changes (per hr):
The rate of air exchange was at least fifteen changes per hour

- Photoperiod (hrs dark / hrs light):
the lighting was controlled by a time switch to give twelve hours continuous light (06:00 to 18:00) and twelve hours darkness

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The left eye remained untreated and was used for control purposes.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit):
A volume of 0.1 ml of the test material

- Concentration (if solution):
For the purpose of the study the test material was used as supplied.

VEHICLE
Not applicable
Duration of treatment / exposure:
Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours
Observation period (in vivo):
Not applicable
Number of animals or in vitro replicates:
Initially, a single rabbit was treated

After consideration of the ocular responses produced in the first treated animal, two additional animals were treated.
Details on study design:
REMOVAL OF TEST SUBSTANCE
Not applicable

SCORING SYSTEM:
The numerical values corresponding to each animal, tissue and observation time were recorded. The data relating to the conjunctivae were designated by the letters A (redness), B (chemosis) and C (discharge), those relating to the iris designated by the letter D and those relating to the cornea by the letters E (degree of opacity) and F (area of cornea involved). For each tissue the score was calculated as follows:

Score for conjunctivae = (A + B + C) x 2
Score for iris = D x 5
Score for cornea = (E x F) x 5

Using the numerical data obtained a modified version of the system described by Kay J H and Calandra J C (1962), J. Soc. Cosmet. Chem. 13, 281 289 (see Appendix 3) was used to classify the ocular irritancy potential of the test material. This was achieved by adding together the scores for the cornea, iris and conjunctivae for each time point for each rabbit. The group means of the total scores for each observation were calculated. The highest of these group means (the maximum group mean score) together with the persistence of the reactions enabled classification of the eye irritancy potential of the test material.

If evidence of irreversible ocular damage is noted, the test material will be classified as corrosive to the eye.

TOOL USED TO ASSESS SCORE:
Examination of the eye was facilitated by the use of the light source from a standard ophthalmoscope

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: 67702 Male
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: No effects observed
Remarks on result:
other: Initial pain reaction = 2
Irritation parameter:
cornea opacity score
Basis:
animal: 67719 Male
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: No effects observed
Remarks on result:
other: Initial pain reaction = 2
Irritation parameter:
cornea opacity score
Basis:
animal: 67720 Male
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: No effects observed
Remarks on result:
other: Initial pain reaction = 2
Irritation parameter:
iris score
Basis:
animal: 67702 Male
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: No effects observed
Remarks on result:
other: Initial pain reaction = 2
Irritation parameter:
iris score
Basis:
animal: 67719 Male
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: No effects observed
Remarks on result:
other: Initial pain reaction = 2
Irritation parameter:
iris score
Basis:
animal: 67720 Male
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: No effects observed
Remarks on result:
other: Initial pain reaction = 2
Irritation parameter:
conjunctivae score
Basis:
animal: 67702 Male
Time point:
24/48/72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: Initial pain reaction = 2
Irritation parameter:
conjunctivae score
Basis:
animal: 67719 Male
Time point:
24/48/72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: Initial pain reaction = 2
Irritation parameter:
conjunctivae score
Basis:
animal: 67720 Male
Time point:
24/48/72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48hours
Remarks on result:
other: Initial pain reaction = 2
Irritation parameter:
chemosis score
Basis:
animal: 67702 Male
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: Initial pain reaction = 2
Irritation parameter:
chemosis score
Basis:
animal: 67719 Male
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: Initial pain reaction = 2
Irritation parameter:
chemosis score
Basis:
animal: 67720 Male
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: Initial pain reaction = 2
Irritant / corrosive response data:
Ocular Reactions
Individual and group mean scores for ocular irritation are given in Table 1 and Table 2.

No corneal or iridial effects were noted during the study.

Moderate conjunctival irritation was noted in all treated eyes one hour after treatment with minimal conjunctival irritation noted at the 24-hour observation.

All treated eyes appeared normal at the 48-hour observation.
Other effects:
Individual bodyweights and bodyweight changes are given in Table 3.

Two animals showed expected gain in bodyweight during the study while the remaining animal showed no gain in bodyweight.

Any other information on results incl. tables

Table1               IndividualScores and Individual Total Scoresfor Ocular Irritation

Rabbit Number and Sex

67702Male

67719Male

67720Male

IPR= 2

IPR = 2

IPR = 2

Time After Treatment

1

Hour

24

Hours

48

Hours

72

Hours

1

Hour

24

Hours

48

Hours

72

Hours

1

Hour

24

Hours

48

Hours

72

Hours

CORNEA

 

 

 

 

 

 

 

 

 

 

 

 

E = Degree of Opacity

0

0

0

0

0

0

0

0

0

0

0

0

F = Area of Cornea Involved

0

0

0

0

0

0

0

0

0

0

0

0

Score (E x F) x 5

0

0

0

0

0

0

0

0

0

0

0

0

IRIS

 

 

 

 

 

 

 

 

 

 

 

 

D

0

0

0

0

0

0

0

0

0

0

0

0

Score (D x 5)

0

0

0

0

0

0

0

0

0

0

0

0

CONJUNCTIVAE

 

 

 

 

 

 

 

 

 

 

 

 

A = Redness

2

1

0

0

2

1

0

0

2

1

0

0

B = Chemosis

1

0

0

0

1

0

0

0

1

0

0

0

C = Discharge

1

0

0

0

1

0

0

0

1

0

0

0

Score (A + B + C) x 2

8

2

0

0

8

2

0

0

8

2

0

0

Total Score

8

2

0

0

8

2

0

0

8

2

0

0

 


Table2               Individual Total Scores and Group Mean Scoresfor Ocular Irritation

Rabbit Number

and Sex

Individual Total Scores At:

1 Hour

24 Hours

48 Hours

72 Hours

67702Male

8

2

0

0

67719Male

8

2

0

0

67720Male

8

2

0

0

Group Total

24

6

0

0

Group Mean Score

8.0

2.0

0.0

0.0

 


Table3               Individual Bodyweights and Bodyweight Change

Rabbit Number
and Sex

Individual Bodyweight (kg)

Bodyweight Change (kg)

Day 0

Day 14

67702Male

3.05

3.09

0.04

67719Male

2.67

2.67

0.00

67720Male

2.63

2.68

0.05


IPR= Initial pain reaction

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Slightly irritating and all recorded effects reversible within 48 hours. Not classified.
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)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 moderate conjunctival irritation. All treated eyes appeared normal at the 48-hour observation.

Conclusion. The test material produced a maximum group mean score of 8.0 and was classified as a minimal irritant (Class 3 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system.