Tetrakis(phenylmethyl)thioperoxydi(carbothioamide)

Endpoint summary

Description of key information

Based on rabbit studies, Tetrabenzylthiuram disulfide is not skin or eye irritating.

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

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

female

Type of coverage:

semiocclusive

Vehicle:

water

Amount / concentration applied:

500 mg substance moistened with 0.3 ml milli-RO water

Duration of treatment / exposure:

4 h

Number of animals:

3

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Irritant / corrosive response data:

The substance caused no adverse effects to the skin in any of the animals during the observation period.

Other effects:

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

Interpretation of results:

GHS criteria not met

Remarks:

Not skin irritating

Conclusions:

Based on the results, the test substance should be considered as non skin 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 mean erythema and edema score (24h -48h -72h) is of 0 for all the three animals.

Based on these results, the test substance should be considered as non-irritating to the skin.

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

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

30 mg

Duration of treatment / exposure:

72h

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

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

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:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

3

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

3

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

3

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

cornea opacity score

Basis:

animal #3

Remarks:

(mean score 3)

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

2

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

2

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Irritant / corrosive response data:

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.
Maximum scores were recorded for conjunctival redness (2) and chemosis (1) at one hour after treatment.

Other effects:

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

Interpretation of results:

GHS criteria not met

Remarks:

Not eye irritating

Conclusions:

Based on these results, TBzTD is not considered as eye irritating.

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 these results, TBzTD is not considered as eye irritating.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Additional information

Skin irritation study

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 mean erythema and edema score (24h -48h -72h) is of 0 for all the three animals.

Based on these results, the test substance should be considered as non-irritating to the skin.

Eye irritation study

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 these results, TBzTD is not considered as eye irritating.

Justification for classification or non-classification

Based on the available data, Tetrabenzylthiuram disulfide should be not classified for irritation endpoints according to the Regulation EC 1272/2008.