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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:
other: limited but acceptable documented study report which meets basic scientific principles

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1973
Reference Type:
publication
Title:
Acute toxicologic evaluation of Santocure NS vulcanization accelerator
Author:
Randall, D.J. and Bannister, R.M.,
Year:
1990
Bibliographic source:
Acute Toxic. Data 1 (2), 104-105

Materials and methods

Principles of method if other than guideline:
Method: Draize Test
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
test substance purity: 97 %

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
100 mg
Duration of treatment / exposure:
24 h
Observation period (in vivo):
7 d
Number of animals or in vitro replicates:
6 animals

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: Draize score
Basis:
mean
Time point:
24/48/72 h
Score:
2.5
Max. score:
110
Reversibility:
fully reversible within: 48 h
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: score = 0 at any time point
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: score = 0 at any time point
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24 h
Score:
7.6
Max. score:
20
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: (conjunctiva + chemosis + discharge) x 2
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24 h
Score:
7.6
Max. score:
20
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: (conjunctiva + chemosis + discharge) x 2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 48 h

Any other information on results incl. tables

The test substance was slightly irritating to the rabbit eye (mean irritation score 24, 48, and 72 hours: 2.5/110.0). Effects on the conjunctivae were noted in all animals at 24 hours (mean score 24 h: 7.6/110) but were reversible within 48 hours. The test substance was classified as not eye irritating according to F.H.S.A.


EU mean chemosis score: 0
EU mean corneal score: 0
EU mean iritis score: 0
Draize score: 2.5/110

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Executive summary:

100 mg of finely ground Santocure NS vulcanization accelerator was placed into the conjunctivial sac of 6 New Zealand albino male and female rabbits. A 7-d observation period followed application. Eye responses were scored in accordance with the Federal Hazardous Substances Act, 21 CFR, § 191.12 (1964).

The test substance was slightly irritating to the rabbit eye (mean irritation score 24, 48, and 72 hours: 2.5/110.0). Effects on the conjunctivae were noted in all animals at 24 hours (mean score 24 h: 7.6/110) but were reversible within 48 hours. The test substance was classified as not eye irritating according to F.H.S.A.