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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:
9 December 1987 to 16 December 1987
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
OECD Guidelines for Testing of Chemicals (1981) No. 405 "Acute Eye Irritation/Corrosion"
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Specific details on test material used for the study:
No further details specified in the study report.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Three New Zealand White rabbits were supplied by David Percival Ltd., Moston, Sandbach, Cheshire, U.K. At the start of the study the animals weighed 2.13 - 2.35 kg and were approximately twelve to sixteen weeks old.
After a minimum acclimatisation period of five days each animal was given a number unique within the study which was written on the inner surface of the ear and on a cage label using a black indelible marker-pen.
The animals were individually housed in suspended metal cages. Free access to mains drinking water and food {Rabbit Diet, Preston Farmers Limited, New Leake, Boston, Lincolnshire, U.K.} was allowed throughout the study.
The animal room was maintained at a temperature of 17 – 19 °C and relative humidity of 45 - 48%. The rate of air exchange was approximately 15 changes per hour and the lighting was controlled by a time switch to give 12 hours light and 12 hours darkness.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
A volume of 0.1 ml of the test material (as measured by gently compacting the required volume into an adapted syringe), which was found to weigh approximately 73 mg was placed into the right eye of each rabbit.
Duration of treatment / exposure:
Single exposure - treated eyes were not rinsed.
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
Three animals
Details on study design:
Immediately before commencement of the test, both eyes of each rabbit provisionally selected, were examined for evidence of ocular irritation or defect using the light source from an ophthalmoscope. Animals showing evidence of ocular lesions were rejected and replaced.
On the day of the test each rabbit was held firmly but gently until quiet. A volume of 0.1 ml of the test material (as measured by gently compacting the required volume into an adapted syringe), which was found to weigh approximately 73 mg was placed into the right eye of each rabbit by gently pulling the lower lid away from the eyeball to form a cup into which the test material was dropped. The upper and lower eyelids were held together for about one second immediately after application, to prevent loss of the test material from the eye, and then released. The left eye remained untreated and was used for control purposes.
Assessment of damage/irritation was made 1, 24, 48 and 72 hours following treatment, according to the numerical evaluation given (i.e. Draize J.H., 1959 Association of Food and Drug Officials of the United States, Austin, Texas, “The Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics”).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0.3
Max. score:
2
Reversibility:
fully reversible within: 72 h
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
mean
Time point:
24/48/72 h
Score:
1.3
Max. score:
3
Reversibility:
fully reversible within: 7 d
Remarks on result:
probability of mild irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 7 d
Remarks on result:
probability of weak irritation
Irritant / corrosive response data:
No corneal damage was noted during the study period.
Iridial inflammation was noted in two treated eyes one hour after treatment and at the 24-hour observation but persisted in only one treated eye at the 48-hour observation. No other iridial effects were noted.
Moderate conjunctival irritation was noted in two treated eyes one hour after treatment with minimal conjunctival irritation in the remaining treated eye.
The conjunctival irritation regressed and one treated eye appeared normal at the 24-hour observation, another appeared normal at the 72-hour observation and the remaining treated eye appeared normal on day seven.
Other effects:
No further effects detailed in the study report.

Any other information on results incl. tables

INDIVIDUAL AND MEAN SCORES FOR CORNEA, IRIS & CONJUNCTIVAE

TEST MATERIAL: DISPERSIONSBLAU F-60 768

RABBIT NUMBER

TIME AFTER TREATMENT

CORNEAL OPACITY

IRIDIAL INFLAMMATION

CONJUNCTIVAL REDNESS

CONJUNCTIVAL CHEMOSIS

158

1 HOUR

24 HOURS

48 HOURS

72 HOURS

7 DAYS

0

0

0

0

0

0

0

0

0

0

1

0

0

0

0

1

0

0

0

0

TOTAL

24, 48 & 72 HOURS

0

0

0

0

MEAN *

0.0

0.0

0.0

0.0

169

1 HOUR

24 HOURS

48 HOURS

72 HOURS

7 DAYS

0

0

0

0

0

1

1

0

0

0

2

3

1

0

0

1

1

0

0

0

TOTAL

24, 48 & 72 HOURS

0

1

4

1

MEAN *

0.0

0.3

1.3

0.3

180

1 HOUR

24 HOURS

48 HOURS

72 HOURS

7 DAYS

0

0

0

0

0

1

1

1

0

0

2

3

3

2

0

2

2

2

1

0

TOTAL

24, 48 & 72 HOURS

0

2

8

6

MEAN *

0.0

0.7

2.7+

1.7

*MEAN = individual mean of 24, 48 and 72-hour readings

+ = positive criteria

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
A single, ocular application of the test material to the non-irrigated eye of three rabbits produced transient iridial inflammation and moderate conjunctival irritation. The ocular irritation regressed and all treated eyes appeared normal seven days after treatment. Based on the results of this study, the substance is not classified as an eye irritant according to CLP criteria.
Executive summary:

A study was performed to assess the irritancy potential of the test material to the eye of the New Zealand White rabbit. The method used followed that described in the OECD Guidelines for Testing of Chemicals (1981) No. 405 “Acute Eye Irritation/Corrosion”. The results of the study will be used to classify the test material according to the E.E.C. Directive of 29 July 1983 83/467/EEC adapting Council Directive 67/548/EEC on the regulations relating to classification, packaging and labelling of dangerous substances.

 

A single, ocular application of the test material to the non-irrigated eye of three rabbits produced transient iridial inflammation and moderate conjunctival irritation. The ocular irritation regressed and all treated eyes appeared normal seven days after treatment.

Based on the results of this study, the substance is not classified as an eye irritant according to CLP criteria.