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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: A study summary was made available by ECHA under Article 25, Para 3., of EC Regulation 1907/2006

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
1993

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: OECD Guideline 405 (1987); EEC Directive 84/449 (1984) Annex V-Method B5, EPA No.798 4500 (1990), MAFF No.4200 (1985)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Amount / concentration applied:
20 mg
Number of animals or in vitro replicates:
6

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
mean
Score:
0.56
Max. score:
2
Reversibility:
fully reversible within: 7d
Remarks on result:
other: Maximum duration72 h; Maximum value at end of observation period 0
Irritation parameter:
chemosis score
Basis:
mean
Score:
0.22
Max. score:
2
Reversibility:
fully reversible within: 7d
Remarks on result:
other: Maximum duration 24h; Maximum value at end of observation period 0.
Irritation parameter:
cornea opacity score
Basis:
mean
Score:
0.06
Max. score:
1
Reversibility:
fully reversible within: 7d
Remarks on result:
other: Maximum duration 24 h: Maximum value at end of observation period 0.
Irritation parameter:
iris score
Basis:
mean
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 7d
Remarks on result:
other: Maximum duration 24 h: Maximum value at end of observation period 0.

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Slight or occasionally moderate transient corneal opacity and iritis were observed amongst the animals during the first 24h after instillation of the test material. Slight or occasionally moderate conjunctival redness accompanied these changes for up to 72 hrs. All of these changes were fully reversible within 7 days. Although eye irritation scores are not available for individual animals, it is considered that the observed effects did not meet the EU CLP criteria for classification as ‘irritating to the eye’.