Registration Dossier

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted in accordance with generally accepted scientific principles, possibly with incomplete reporting or methodological deficiencies, which does not affect the quality of relevant results.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report Date:
1977

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
other: The procedure followed was a modification of that used by Dr. J.H. Draize in Appraisal of. The Safety of Chemicals in Foods, Drugs and Cosmetics.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Test item recieved: 1st July 1977
Test material name: Distilled Lanolin fatty acids
Lot number: 1110916

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes
Duration of treatment / exposure:
The rabbits were injected once and obsevred daily for 7 days.
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
6 rabbits mixed sex

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
iris score
Remarks:
animal 1
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0.33
Max. score:
2
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: max score of 1 seen at 48 hours
Irritation parameter:
iris score
Remarks:
animal 2
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
2
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
iris score
Remarks:
animal 3
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
2
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
iris score
Remarks:
animal 4
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0.66
Max. score:
2
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
iris score
Remarks:
animal 5
Basis:
mean
Time point:
other: 24. 48 and 72 hours
Score:
0
Max. score:
2
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
iris score
Remarks:
animal 6
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0.33
Max. score:
2
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Remarks:
animal 1
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
1.66
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
chemosis score
Remarks:
animal 2
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
chemosis score
Remarks:
animal 3
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0.66
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: a max score of 2 was seen at 24 hours
Irritation parameter:
chemosis score
Remarks:
animal 4
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
chemosis score
Remarks:
animal 5
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
chemosis score
Remarks:
animal 6
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0.66
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: score of one seen at 24, and 48 hours
Irritation parameter:
cornea opacity score
Remarks:
opacity - animal 1
Basis:
mean
Time point:
other: 24,48 and 72 hours
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Remarks:
opacity - animal 2
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
cornea opacity score
Remarks:
opacity - animal 3
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
cornea opacity score
Remarks:
opacity - animal 4
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: max score of 4 seen at 48 and 72 hours
Irritation parameter:
cornea opacity score
Remarks:
opacity - animal 5
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
cornea opacity score
Remarks:
opacity - animal 6
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: max score of 1 seen at 24 hours

Applicant's summary and conclusion

Interpretation of results:
other: Not classified
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Even though the test material showed signs of causing irriattion to the eye in New Zealand White Rabbits, however the results were not significant enough to classify the syubstance as an irritant according to the Globally Harmonised system (GHS) or the Dangerous Substances Directive (DSD).
Executive summary:

The test material was not clasisifed for eye irrritation according to the Globally Harmonised System (GHS) or the Dangerous Substances Directive (DSD).