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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:
February 2, 1981 to February 9, 1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Justification for type of information:
None

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Proposed guidelines of the United States Environmental Protection Agency (EPA) § 163.81-4 "Primary eye irritatioirritation study", Federal Register, Vol. 43, No. 163, August 22, 1978.
Deviations:
no
Principles of method if other than guideline:
Guideline followed
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
Identification: FAT 20063/D TE
Lot: BS-BOP 01-15
Appearance: Dark blue powder
Specific details on test material used for the study:
Physical appearance: blue powder
Batch No.: WS 42065.02

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
The test was performed on 3 male and 3 female New Zealand White rabbits bred and raised on the premises weighing 2 to 3 kgs. The animals were housed individually in metal cages, numbered by ear tags, were kept at a constant room temperature of 22 ± 2 °C, at a relative humidity of 55 ± 10 % and on a 10 hour light cycle day. The animals had ad libitum access to standard rabbit food - NAFAG, No. 814, Gossau SG - and water. Prior to treatment they were adapted for a minimum of 4 days. Only rabbits with normal ophthalmic findings were used for these tests.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The right eye was not treated and served as an untreated control.
Amount / concentration applied:
0.1 g
Duration of treatment / exposure:
In 3 of the 6 rabbits approximately 30 seconds after treatment the treated eye was flushed with 10 ml of physiological saline, while for remaining 3 rabbits the treated eyes were not washed .
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3 males and 3 females

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
Reversibility:
other: No effects observed
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: No effects observed
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 96 hours
Remarks on result:
other: Total score for conjuctival redness/total number of observations= 12/18= 0.67
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0.22
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Total score for conjuctival redness/total number of observations= 4/18= 0.22
Irritant / corrosive response data:
- A slight persistant blue coloration of the sclera was observed throughout the test.
- FAT 20'063/B was found to cause a minimal irritation when applied to the rabbit eye mucosa.
- Rinsing the eyes following instillation was of no effect.

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test substance can be considered as not an eye irritant.
Executive summary:

The eye irritation potential of the test substance was evaluated in a study conducted according to the Proposed Guidelines of the United States Environmental Protection Agency (EPA) § 163.81-4 "Primary eye irritation study", Federal Register, Vol. 43, No. 163, August 22, 1978. The test was performed on 3 male and 3 female New Zealand White rabbits weighing 2 to 3 kgs. The test material in an amount of 0.1 g was inserted into the conjunctival sac of the left eye of the rabbits and the lids were gently closed for a few seconds. The right eye was not treated and served as an untreated control. In 3 of the 6 rabbits approximately 30 seconds after treatment the treated eye was flushed with 10 ml of physiological saline. The eye irritation was appraised with a slit-lamp on day 1, 2, 3, 4 and 7 and was scored for each individual rabbit. The mean reaction scores for cornea, iris and conjunctiva observed after 1, 2, 3, 4 and 7 days were summed up and the sum divided by 5. This procedure was carried out separately for unrinsed (A) and rinsed (B) eyes respectively. A slight persistant blue coloration of the sclera was observed throughout the test. Primary irritation index in unrinsed as well as rinsed eyes was 1.1. Hence the test substance was found to cause a minimal irritation when applied to the rabbit eye mucosa. Rinsing the eyes following instillation was of no effect. However, the scores do not meet the CLP [Regulation (EC) No. 1272/2008] criteria for classification, hence the test substance can be considered as not irritating to eyes.