Registration Dossier

Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

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: Basic data given. Lack of details on the test material and limited documentation.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979

Materials and methods

Principles of method if other than guideline:
The test was performed according to F.D.A. Handbook, Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, F.D.A. (1959) p.47.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Glycerides, mixed C8-10 and succinyl
EC Number:
294-620-0
EC Name:
Glycerides, mixed C8-10 and succinyl
Cas Number:
91744-56-8
Molecular formula:
Not applicable: Complex UVCB substance
IUPAC Name:
Glycerides, mixed C8-10 and succinyl
Details on test material:
- Name of test material (as cited in study report): only trade name given
- Physical state: clear oil-like material
- Analytical purity: no data

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye served as control
Amount / concentration applied:
- Amount applied: 0.1 mL
Duration of treatment / exposure:
3 animals: 4 sec
3: single application without washing
Observation period (in vivo):
7 days
Reading time points: 1, 24, 48, 72 and 96 h and 7 days
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: in 3 rabbits, the treated eye was washed with 20 mL lukewarm water after installation. In the other animals, the treated eye remained unwashed.
- Time after start of exposure: 4 sec

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
of 3 animals
Time point:
24/48/72 h
Score:
0.55
Max. score:
3
Reversibility:
fully reversible within: 72h
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: mean after 24, 48 and 72 h
Score:
0
Max. score:
3
Reversibility:
other: reversibility not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: mean after 24, 48 and 72 h
Score:
0.33
Max. score:
3
Reversibility:
other: reversibility not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: mean after 24, 48 and 72 h
Score:
1.33
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
of 3 animals
Time point:
other: mean after 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
/Mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
/Mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
/Mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
of 3 animals
Time point:
other: mean after 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
/Mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
/Mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
/Mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
mean
Remarks:
of 3 animals
Time point:
other: mean after 24, 48 and 72 h
Score:
0
Max. score:
2
Reversibility:
other: reversibility not applicable
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
/Mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
/Mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
/Mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritant / corrosive response data:
Slight to well-defined reddening of the conjunctival membranes was exhibited by 2 of 3 animals in which the treated eye remained unwashed. However, this effect failed to persist beyond 72 h after administration. No irritant responses were observed in any of the remaining individuals in this test group. No evidence of irritation to either the cornea or iris and no discharges were detected in treated animals with unwashed eyes. No irritating effects on cornea, iris and conjunctivae as well as no discharges were observed in treated animals with washed eyes. However, animals with washed eyes were not considered for classification, since test substance was already washed out 4 sec after test substance installation.
Other effects:
No further local or systemic effects were observed.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified

Categories Display