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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:
January from 18th to 25th, 2001
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report Date:
2001

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
1987
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rat
Strain:
New Zealand White

Test system

Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 ml (67.3 mg) of the test material was administered to the non irrigated eye.
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
Three rabbits

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: 3/3
Time point:
24/48/72 h
Score:
< 1
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal: 3/3
Time point:
24/48/72 h
Score:
< 1
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal:
Time point:
24/48/72 h
Score:
< 2
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
animal: 3/3
Time point:
24/48/72 h
Score:
< 2
Reversibility:
fully reversible within: 48 hrs
Irritant / corrosive response data:
Maximum Group Mean Score was 4.1
Classification: mild irritant (class 4 on a 1-8 SCALE).
The test material did not meet the criteria for classification as irritant or conosive according to EU labelling regulations Commission Directive 93/21/EEC. No symbol and risk phrase are required.

Any other information on results incl. tables

lndividual Scores for Ocular Irritation

Animal N. Reaction Observation at Mean 24/48/72 hrs
1 hr 24 hrs 48 hrs 72 hrs
146 male Corneal opacity 0 0 0 0 0.00
Iris 0 0 0 0 0.00
Conjunctival redness 0 0 0 0 0.00
Conjunctival chemosis 0 0 0 0 0.00
151 male Corneal opacity 0 0 0 0 0.00
Iris 0 0 0 0 0.00
Conjunctival redness 1 1 1 0 0.67
Conjunctival chemosis 1 1 1 0 0.33
153 male Corneal opacity 0 0 0 0 0.00
Iris 0 0 0 0 0.00
Conjunctival redness 1 0 0 0 0.00
Conjunctival chemosis 0 0 0 0 0.00

Applicant's summary and conclusion

Interpretation of results:
other: not classified, according to the CLP Regulation (EC) No 1272/2008
Conclusions:
Non eye irritating
Executive summary:

A study was performed to assess the irritation of the test material to the eye of the New Zealand White rabbit (SPL Standard Test Method 560.06). The method followed OECD Guidelines for Testing of Chemicals (1987) No. 405 "Acute Eye Irritation/Corrosion" and Method B5 of Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/548/EEC). A single application of 0.1 ml (67.3 mg) of the test material was administered to the non irrigated eye of three rabbits. Ocular reactions were record at 1, 24, 48 and 72 hours after administration.

The Maximum Group Mean Score was 4.1 and the related classification was as mild irritant (class 4 on a 1 -8 SCALE).

Any way, the  test material did not meet the criteria for classification as irritant or conosive according to EU labelling regulations Commission Directive 93/21/EEC. No symbol and risk phrase are required.

Conclusion

The mean values from gradings at 24, 48 and 72 hours were lower than 1 for corneal opacity, lower than 1 for iritis, lower than 2 for both conjunctival redness and oedema, in all of the three tested animals.

Therefore, the substance does not meet the criteria to be classified as eye irritating, according to the CLP Regulation (EC) No 1272/2008.