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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
Study period:
From 1991-08-20 to 1991-08-30
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
Study performed according to OECD test guideline No. 405 and in compliance with GLP with minor deviations (age of animals at study initiation not reported).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
age of animals at study initiation not reported
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
age of animals at study initiation not reported
Principles of method if other than guideline:
not applicable
GLP compliance:
yes (incl. certificate)
Remarks:
Inspected on 19 June 1990. Signed on 5 October 1990.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
- Physical state: colourless liquid
- Storage condition of test material: in the dark at about 4°C

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Ranch Rabbits, Crawley Down, Sussex.
- Age at study initiation: no data
- Weight at study initiation: 2.8-3.2 kg
- Housing: individually in grid bottomed metal cages.
- Diet (e.g. ad libitum): antibiotic free rabbit diet ad libitum (SQC Stanrab, produced by Special Diets Services, Witham, Essex)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-21 °C.
- Humidity (%): 59-69 % with the exception of one occasion when a value of 76 % relative humidity was recorded.
- Air changes (per hr): no data
- Photoperiod: 12 hrs dark / 12 hrs light

IN-LIFE DATES: no data

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the contralateral eye remained untreated
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): not applicable

VEHICLE
Not applicable
Duration of treatment / exposure:
The eye was not rinsed after the instillation of the test item.
Observation period (in vivo):
Examination made 1, 24, 48 and 72 hours following instillation
Number of animals or in vitro replicates:
4 females
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): not applicable
- Time after start of exposure: not applicable

SCORING SYSTEM: Draize scale according to the OECD guideline No. 405

TOOL USED TO ASSESS SCORE: standard light source designed to comply with the requirements of BS 950 Part 1 (Artificial Daylight for the Assessment of Colour)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
mean
Remarks:
(4 animals)
Time point:
24/48/72 h
Score:
0.4
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: 0.7/0.3/0.0/0.7
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
(4 animals)
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: 0.7/0.0/0.0/0.3
Irritation parameter:
other: discharge
Basis:
mean
Remarks:
(4 animals)
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
cornea opacity score
Remarks:
(opacity)
Basis:
mean
Remarks:
(4 animals)
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Remarks:
(area)
Basis:
mean
Remarks:
(4 animals)
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Remarks:
(4 animals)
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritant / corrosive response data:
One hour after dosing, some discharge and chemosis and definite conjunctival redness (grade 2-3) were noted in all 4 animals. Between 24 and 48 hours the irritation was reduced with only slight chemosis and/or redness in some animals. At 72 hours, no signs of irritation were detected in any animals. No corneal or iridial irritation occurred in any animal during the study.
Other effects:
No other effect

Any other information on results incl. tables

Table 7.3.2/1: Mean irritant/corrosive response data of 4 animals at each observation time up to removal from the test

Score at time point / Reversibility

Cornea

Iris

(/2)

Conjunctivae

Opacity

(/4)

Area

(/4)

Redness

(/3)

Chemosis

(/4)

Discharge

(/3)

1 h

0

0

0

2.25

1.50

1.25

24 h

0

0

0

0.75

0.50

0

48 h

0

0

0

0.50

0.25

0

72 h

0

0

0

0.00

0.00

0

Average 24h, 48h, 72h

0

0

0

0.31

0.25

0

Reversibility*)

-

-

-

c.

c.

-

Average time for reversion

-

-

-

72 h

72 h

24 h

*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible

Table 7.3.2/2: Individual irritant/corrosive response data at each observation time up to removal from the test

 

Score at time point / Reversibility

Cornea

Iris

(/2)

Conjunctivae

Opacity

(/4)

Area

(/4)

Redness

(/3)

Chemosis

(/4)

Discharge

(/3)

1 h

0 / 0 / 0 / 0

0 / 0 / 0 / 0

0 / 0 / 0 / 0

3 / 2 / 2 / 2

2 / 1 / 1 / 2

1 / 1 / 1 / 2

24 h

0 / 0 / 0 / 0

0 / 0 / 0 / 0

0 / 0 / 0 / 0

1 / 1 / 0 / 1

1 / 0 / 0 / 1

0 / 0 / 0 / 0

48 h

0 / 0 / 0 / 0

0 / 0 / 0 / 0

0 / 0 / 0 / 0

1 / 0 / 0 / 1

1 / 0 / 0 / 0

0 / 0 / 0 / 0

72 h

0 / 0 / 0 / 0

0 / 0 / 0 / 0

0 / 0 / 0 / 0

0 / 0 / 0 / 0

0 / 0 / 0 / 0

0 / 0 / 0 / 0

Average 24h, 48h, 72h

0 / 0 / 0 / 0

0 / 0 / 0 / 0

0 / 0 / 0 / 0

0.7 / 0.3 / 0.0 / 0.7

0.7 / 0.0 / 0.0 / 0.3

0 / 0 / 0 / 0

Reversibility*)

-

-

-

 c.

c. 

c. 

Average time (unit) for reversion

-

-

-

 72 h

72 h 

24 h 

*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the test conditions, the test material is not classified as irritating to eyes according to the criteria of the Annex VI of the Regulation (EC) No 1272/2008 (CLP) and of the GHS.
Executive summary:

In an eye irritation study performed according to the OECD guideline No. 405, and in compliance with GLP, 0.1 mL of undiluted test material was instilled into the right eye of 4 female New Zealand White Rabbits. The eyes were not rinsed after the instillation of the test item.The left eye of each rabbit served as control. Animals were observed at 1, 24, 48 and 72 hours after dosing under a standard light source. The reactions in the conjunctiva (redness, chemosis and discharge), the iris and the cornea (opacity and area involved) were scored according to the Draize scale. 

 

The calculated mean score for each individual lesion for all animals within 3 scoring times (24, 48 and 72 hrs) were as follows: 0.3 for chemosis; 0.4 for redness; 0.0 for discharge, iris and corneal lesions.

The calculated mean score for each individual lesion for each individual animal within 3 scoring times (24, 48 and 72 hrs) were as follows: 0.7/0.0/0.0/0.3 for chemosis; 0.7/0.3/0.0/0.7 for redness; 0/0/0/0 for discharge, iris and corneal lesions.

The effects observed were all reversible within 72 hours.

 

Under the test conditions, the test material is not classified as irritating to eyes according to the criteria of the Annex VI of the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.

This study is considered as acceptable and satisfies the requirement for eye irritation endpoint.