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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
Study period:
December 23, 1987 to March 24, 1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
Guideline study performed in compliance with GLP, available as unpublished report, no restrictions, fully adequate for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Directive 84/449/EEC, Annex V, B.5
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Tetrakis(phenylmethyl)thioperoxydi(carbothioamide)
EC Number:
404-310-0
EC Name:
Tetrakis(phenylmethyl)thioperoxydi(carbothioamide)
Cas Number:
10591-85-2
Molecular formula:
C30H28N2S4
IUPAC Name:
tetrakis(phenylmethyl)thioperoxydi(carbothioamide)
Specific details on test material used for the study:
Nature of substance: creamy powder

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Albino rabbit, New Zealand White, female

Test system

Controls:
other: The untreated eye was used as a control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 30 +/+ 2 mg


VEHICLE
- No vehicle
Duration of treatment / exposure:
72 hours
Observation period (in vivo):
16 days
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: Day 1: redness score 3 for nictating membrane; day 7: redness score 1 only for eyelids.
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: Day 2 & 3: redness score only for nictating membrane
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 16 days
Irritation parameter:
conjunctivae score
Remarks:
(discharge)
Basis:
animal: #1, #2, and #3
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal: #1, #2, and #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal: #1, #2, and #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal: #1, #2, and #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 16 days
Reversibility of any observed effect: Changes not fully reversible within 14 days
Other effects:
Maximum scores were recorded for conjunctival redness (2) and chemosis (1) at one hour after treatment.

Any other information on results incl. tables

Instillation of the test substance into one of the eyes of each of three albino rabbits affected the iris and the conjunctivae.

Approximately 70 minutes after exposure animals #1 and #2 showed slight and animal #3 diffuse conjunctival redness. Animal #1 also

showed iridial injection temporary, as well as slight chemosis, which was observed in all three rabbits. The slight conjunctival redness

noted had resolved in animal #2 by day 7, in animal #1 by day 14 and in animal #3 by day 16.

Treatment of the eye with fluorescein approximately 24 hours after test substance instillation showed no corneal epithelial damage in

any of the rabbits. Only animal #1 showed at the first observation slight lacrimation.

No signs of systemic intoxication were observed in any of the rabbits.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based on the estimated Draize score of 7.0 (70 minutes) the test substance should be classified as mildly irritating according to the scheme of Kay and Calandra.
According to the EEC criteria for classification and labelling of dangerous substances, the test substance does not need to be labelled as an eye irritant.
Executive summary:

Tetrabenzylthiuram disulfide (TBzTD) was tested in the rabbit acute eye irritation/corrosion test.

Instillation of approximately 30 mg of the test substance in one of the eyes of each of three albino rabbits resulted in adverse effects on the conjunctivae only.

Approximately 70 minutes after exposure all animals showed slight to diffuse conjunctival redness and slight chemosis and one animal

showed iridial injection. The injection of the iris and the chemosis had resolved within 24 hours. The conjunctival redness resolved between days 7 and 16.

Based on the estimated Draize score of 7.0 (70 minutes) the test substance should be classified as mildly irritating according to

the scheme of Kay and Calandra.

According to the criteria laid down in Annex VI of the EEC Council Directive 67/548/EEC TBzTD does not need to be labelled as an eye irritant.

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