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Description of key information

Based on the results of the skin irritation test (EU Method B4, GLP compliant) and the eye irritation test (EU Method B5, GLP compliant), the test substance is not irritating to the skin and eye.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
December 23, 1987 to March 8, 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Guideline study performed in compliance with GLP, available as unpublished report, no restrictions, fully adequate for assessment.
Qualifier:
according to guideline
Guideline:
other: Directive 84/449/EEC, Annex V, B.4
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
Albino rabbit, New Zealand White, female
Type of coverage:
semiocclusive
Vehicle:
other: 500 mg substance moistened with 0.3 ml milli-RO water
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
4 h
Number of animals:
3
Irritation parameter:
erythema score
Basis:
animal: #1, #2, and #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal: #1, #2, and #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Other effects:
The substance caused no adverse effects to the skin in any of the animals during the observation period. No signs of systemic intoxications were observed in any of the rabbits.
Interpretation of results:
GHS criteria not met
Conclusions:
Based on the results and the calculated primary irritation index (modified) of 0, the test substance should be considered as non-irritating.
Executive summary:

Tetrabenzylthiuram disulfide (TBzTD) was tested in the rabbit primary skin irritation/corrosion test.

The flank skin of 3 albino rabbits was exposed to 0.5 gram of the test substance moistened with 0.3 ml Milli-RO water for 4 hours using semi-occlusive dressings. The test substance caused no adverse effects to the skin in any of the animals during the observation period.

The primary skin irritation index amounted to 0. Based on these results, the test substance should be considered as non-irritating to the skin.

According to the criteria laid down in Annex VI of the EEC Council Directive 67/548/EEC, the test substance need not be labelled as a skin irritant.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
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.
Qualifier:
according to guideline
Guideline:
other: Directive 84/449/EEC, Annex V, B.5
GLP compliance:
yes
Specific details on test material used for the study:
Nature of substance: creamy powder
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Albino rabbit, New Zealand White, female
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
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.

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.

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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation

Tetrabenzylthiuram disulfide (TBzTD) was tested in the rabbit primary skin irritation/corrosion test performed in accordance with Directive EEC 84/449, Annex V; B.4 and in compliance with GLP. The flank skin of 3 albino rabbits was exposed to 0.5 gram of the test substance moistened with 0.3 ml Milli-RO water for 4 hours using semi-occlusive dressings. The test substance caused no adverse effects to the skin in any of the animals during the observation period. The primary skin irritation index amounted to 0 (mean erythema and edema score at 24, 48 and 72 hours was 0). Based on these results, the test substance should be considered as non-irritating to the skin.

Eye irritation

Tetrabenzylthiuram disulfide (TBzTD) was tested in the rabbit acute eye irritation/corrosion test in accordance with Directive EEC 84/449, Annex V; B.5 and in compliance with GLP. 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. The mean conjunctivae score (24, 48, and 72 hours) was 1. 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.


Justification for classification or non-classification

Based on the results of skin irritation and eye irritation test, the substance does not need to be classified according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.

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