Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
28-07-1999 to 31-07-1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study according to international guidelines.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report date:
1999

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EPA OTS 798.4500 (Acute Eye Irritation)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid: viscous
Details on test material:
- Name of test material (as cited in study report): Castor Oil/Maleic Anhydride Adduct CAS# 10502-43-12
- Date received: 16 June 1998
- Description: clear yellow liquid
- Specific gravity: 1.03

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
3/3 rabbit eyes washed after 30 seconds
6/6 rabbit eyex unwashed for 72 h
Observation period (in vivo):
1, 24, 48, 72 h
Number of animals or in vitro replicates:
9

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
(redness + discharge)
Basis:
animal: #1, 2, 4, 5 and 6
Time point:
other: 1 h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 24 h
Remarks on result:
other: Unwashed eyes
Irritation parameter:
conjunctivae score
Remarks:
(redness + discharge)
Basis:
animal: #1, 2, 4, 5 and 6
Time point:
other: 24-72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
other: Unwashed eyes
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #3
Time point:
other: 1 h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: Unwashed eyes
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #3
Time point:
other: 24 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: Unwashed eyes
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #3
Time point:
other: 48-72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Remarks:
(discharge)
Basis:
animal #3
Time point:
other: 1 h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 24 h
Remarks on result:
other: Unwashed eyes
Irritation parameter:
conjunctivae score
Remarks:
(discharge)
Basis:
animal #3
Time point:
other: 24-72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
other: Unwashed eyes
Irritation parameter:
conjunctivae score
Remarks:
(redness + discharge)
Basis:
animal: #7
Time point:
other: 1 h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 24 h
Remarks on result:
other: Washed eyes
Irritation parameter:
conjunctivae score
Remarks:
(redness + discharge)
Basis:
animal: #7
Time point:
other: 24-72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
other: Washed eyes
Irritation parameter:
chemosis score
Basis:
animal: #7
Time point:
other: 1 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 24 h
Remarks on result:
other: Washed eyes
Irritation parameter:
chemosis score
Basis:
animal: #7
Time point:
other: 24-72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
other: Washed eyes
Irritation parameter:
conjunctivae score
Remarks:
(redness + discharge)
Basis:
animal: #8
Time point:
other: 1 h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 24 h
Remarks on result:
other: Washed eyes
Irritation parameter:
conjunctivae score
Remarks:
(redness + discharge)
Basis:
animal: #8
Time point:
other: 24-72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
other: Washed eyes
Irritation parameter:
conjunctivae score
Remarks:
(redness + discharge)
Basis:
animal: #9
Time point:
other: 1 h
Score:
2
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
other: Washed eyes
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal: #9
Time point:
other: 24-48 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: Washed eyes
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal: #9
Time point:
other: 72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
other: Washed eyes
Irritation parameter:
chemosis score
Basis:
animal: #9
Time point:
other: 1 h
Score:
1
Max. score:
1
Reversibility:
fully reversible
Remarks on result:
other: Washed eyes
Irritation parameter:
chemosis score
Remarks:
+ discharge
Basis:
animal: #9
Time point:
other: 24-72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
other: Washed eyes
Other effects:
No other effects observed, systemic observations were normal.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substance is not classified as an eye irritant since scores for irritation parameters were below 2 after 24 h following exposure.