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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

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.