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Diss Factsheets

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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP and guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report date:
1985

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EPA OPP 81-4 (Acute Eye Irritation)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
N,N-dicyclohexylbenzothiazole-2-sulphenamide
EC Number:
225-625-8
EC Name:
N,N-dicyclohexylbenzothiazole-2-sulphenamide
Cas Number:
4979-32-2
Molecular formula:
C19H26N2S2
IUPAC Name:
N-(1,3-benzothiazol-2-ylsulfanyl)-N-cyclohexylcyclohexanamine
Details on test material:
Santocure DCBS, lot/batch no.: 84/129/01

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 h and 7 d after treatment
Number of animals or in vitro replicates:
6

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: slight effects 1 h after treatment
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 24 h
Remarks on result:
other: slight effects 1h after treatment
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Remarks on result:
other: no effects
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: *1/6 animal with (+) grade at 24 and 48 h, reversible within 72 h

Any other information on results incl. tables

DCBS produced only mild, transient ocular irritation, consisting primarily of mild conjunctivial irritation (redness, chemosis and/or discharge) and iridial changes, with most severe effects occurring at one hour. No responses considered to be positive under the reference regulations were seen. All animals were free of ocular irritation within 24 hours to 7 days after instillation of the test material.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Executive summary:

In a GLP and EPA guideline study with six New Zealand White rabbits, a single application of 0.1cc DCBS in the lower conjunctivial sac of the right eye produced only mild and transient ocular irritation, consisting primarily of mild conjunctivial irritation (redness, chemosis and/or discharge) and iridial changes, with most severe effects occurring at one hour. All animals were free of ocular irritation within 24 hours to 7 days after instillation of the test material (Monsanto Co. 1985).