Registration Dossier

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:
guideline study without detailed documentation

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
2005

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: OECD [C(99) 186 (Final)]
Deviations:
not specified
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
Nature of substance: ESACURE 1001

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Amount / concentration applied:
100 mg
Number of animals or in vitro replicates:
9

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
mean
Score:
ca. 2.77
Max. score:
3
Remarks on result:
other: Max. duration: h; Max. value at end of observation period: 3
Irritation parameter:
chemosis score
Basis:
mean
Score:
ca. 2.66
Max. score:
3
Remarks on result:
other: Max. duration: h; Max. value at end of observation period: 2
Irritation parameter:
cornea opacity score
Basis:
mean
Score:
1.27
Max. score:
3
Remarks on result:
other: Max. duration: h; Max. value at end of observation period: 2
Irritation parameter:
iris score
Basis:
mean
Score:
1.22
Max. score:
2
Remarks on result:
other: Max. duration: h; Max. value at end of observation period: 2
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 7 days
Other effects:
In the group of six rabbits, notable occular changes consisting of conjunctival redness and chemosis, iris congestion and corneal opacity were noted up to 72 hours - 7 days after exposure.

Thre native animals were trated at the same dose of 0.1 of test article, but eyes were washed at 2-3 mins after application, then observed and scored as for the previous six animals. Slight ocular changes, confined to conjunctival redness were noted up to 24 hours after exposure.

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria