Registration Dossier

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
other: ECHA inquiry result
Title:
Unnamed
Year:
1999

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: EPA method, cfr OECD Guidelne 405, 1987
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:
other: New Zealand white rabbits

Test system

Amount / concentration applied:
62 MG
Number of animals or in vitro replicates:
6

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
mean
Score:
2.4
Max. score:
3
Remarks on result:
other: Max duration: 21h; Max. value at end of observation period: 2
Irritation parameter:
chemosis score
Basis:
mean
Score:
1.9
Max. score:
2
Remarks on result:
other: Max duration: 21h; Max. value at end of observation period: 2
Irritation parameter:
cornea opacity score
Basis:
mean
Score:
2.1
Max. score:
3
Remarks on result:
other: Max duration: 21h; Max. value at end of observation period: 4
Irritation parameter:
iris score
Basis:
mean
Score:
1
Max. score:
1
Remarks on result:
other: Max duration: 21h; Max. value at end of observation period: 1
Irritant / corrosive response data:
Reversibility of any observed effect: Change not fully reversible within 21 days
Other effects:
Additional ocular findings includedsloughing of the corneal epithelium, coreneal neovascularization and raised area on the corneal surface.

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information