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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:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1973
Report Date:
1973
Reference Type:
publication
Title:
Acute toxicologic evalaution of Santocure vulcanization accelerator
Author:
Randall, D.J. and Bannister, R.M.,
Year:
1990
Bibliographic source:
Acute Toxic. Data 1 (2), 105-106

Materials and methods

Principles of method if other than guideline:
100 mg of finely ground test substance was placed into the conjunctival 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 Substance Act, 21 CFR, § 191.12 (1964).
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
test substance: Santocure CBS

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Duration of treatment / exposure:
24 h
Observation period (in vivo):
24, 48, 72, 168 h
Number of animals or in vitro replicates:
6

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
1.8
Max. score:
110
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: at 24 h: slight erythema and moderate discharge
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
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:
5.66
Max. score:
20
Reversibility:
fully reversible within: 40 hours
Remarks on result:
other: (conjunctiva + chemosis + discharge) x 2
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24 h
Score:
5.66
Max. score:
20
Reversibility:
not 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:
20
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
20
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
72 h
Score:
2
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
20
Reversibility:
fully reversible

Any other information on results incl. tables

Number of animals: 6
Test results:
Draize score: 1.8/110
1 hr: slight erythema, copious discharge

24 h: slight erythema in five instances, moderate discharge

The test substance was slightly irritating to the rabbit eye, 1.8/110.0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In an eye irritation test with six New Zealand albino rabbits the test substance caused slightly and transient erythema of the conjunctivae. No effects were noted after 48 hours. An irritation score of 1.8 (Draize score: 1.8/110) was indicated (Monsanto 1973).
Executive summary:

In an eye irritation test with six New Zealand albino rabbits the test substance caused slightly and transient erythema of the conjunctivae. No effects were noted after 48 hours. An irritation score of 1.8 (Draize score: 1.8/110) was indicated (Monsanto 1973).