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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 13 to 17 December 1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report Date:
1995

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
Adopted 31st July 1992
Deviations:
no
Principles of method if other than guideline:
not applicable
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
Test material identification: ST 02 C 94
Description: colourless liquid
Date received; 25th November 1994
Specific details on test material used for the study:
Storage conditions: refrigerator 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: Froxfield Farms (UK) Limited, Froxfield, Hampshire - U.K.
- Housing: The animals were individually housed in grid bottomed metal cages.
- Diet (e.g. ad libitum): ad libitum (antibiotic free rabbit diet (SQC staudardrabbit pellets produced by Special Diet Services, Witham, Essex)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-21
- Humidity (%): 44-61
- Air changes (per hr): air conditionned room
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: left eye of rabbits
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL/eye
Duration of treatment / exposure:
72 hours
Observation period (in vivo):
Directly after instillation and after 1, 24, 48 and 72 hours
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): none

SCORING SYSTEM & TOOL USED TO ASSESS SCORE: treated eyes were examined under a standard light source designed to comply with the requirements of BS 950 Part I (Artificial Daylight for the Assessment of Colour) , see "Attached background material"

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: #1 & #2 & #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal: #1 & #2 & #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal: #1 & #2 & #3
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal: #1 & #2 & #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
See "Illustration" for detailed results
Other effects:
none

Any other information on results incl. tables

none

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 Regulation (EC) No 1272/2008 (CLP).
Executive summary:

Introduction. The purpose of this study was to assess the degree of ocular irritation produced when the test article, ST 02 C 94, was introduced into the eye of the albino rabbit. The study was conducted in accordance with the EU Method B.5, as described in OJ L 383 A of 29th December 1992, an annex to Commission Directive 92/69/EEC of 31st July 1992. Classification and labelling requirements were determined in accordance with Commission Directive 93/21/EEC of 27th April 1993.

Methods. Initially, one animal only was dosed in a preliminary screen to assess the potential irritancy of the test article.

Twenty four hours after dosing, there were no signs of irritation in the treated eye of this first animal and a further 2 animals were dosed, bringing the total number of rabbits used in the study to 3.

A 0.1 ml aliquot of the pure test article was instilled into the right eye of each rabbit and the resulting reaction to treatment was assessed one, 24, 48 and 72 hours after treatment.

One hour after dosing, very slight conjunctival hyperaemia was noted in the treated eye of all 3 rabbits. However, no signs of ocular irritation were apparent in any animal at all subsequent examinations.

No severe ocular lesions were detected in the treated eye of any animal and the irritation produced by the test article would not be deemed to be significant according to the criteria described in the Annex VI of the Directive 67/548/EEC and of the Regulation (EC) No 1272/2008 (CLP).

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