Tetrakis(phenylmethyl)thioperoxydi(carbothioamide)

Endpoint summary

Description of key information

The acute toxicity of Tetrabenzylthiuram disulfide was evaluated after oral and inhalation exposure in rats.

No mortality was observed in both study, therefore it is considered that Tetrabenzylthiuram disulfide doesn't cause acute toxicity.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Qualifier:

according to guideline

Guideline:

other: Directive EEC 84/449, Annex V, B.1

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Wistar

Remarks:

Wistar CrL: (Wi) BR (outbred, SPF quality)

Route of administration:

oral: gavage

Vehicle:

methylcellulose

Details on oral exposure:

Substance delivered in 1% aqueousmethyl cellulose.

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Sex:

male/female

Dose descriptor:

LD0

Effect level:

5 000 mg/kg bw

Remarks on result:

other:

Remarks:

no mortality

Mortality:

No mortality occurred at 5000 mg/kg/day in males and females

Clinical signs:

other: No signs of systemic toxicity were observed during the observation period.

Gross pathology:

No effects were found after sacrifice on day 15.

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions used in this study, it is concluded that the oral LD50 value of TBzTD in the rat exceeds 5000 mg/kg bodyweight for both males and females

Executive summary:

One group of Wistar rats, comprising 5 males and 5 females, received a total oral dose of Tetrabenzylthiuram disulfide at 5000 mg/kg bw (2500 mg/kg twice within 24 hours).

No mortality occurred and no signs of toxicity were observed during the 14 day observation period.

Post-mortem examination of all animals at the end of the study did not reveal any changes that were considered to have arisen as a result of treatment.

Since no mortality occurred, the oral LD50 value for both males and females was noted as exceeding 5000 mg/kg bodyweight.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

5 000 mg/kg bw

Quality of whole database:

The study is considered as reliable.

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

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:

OECD Guideline 403 (Acute Inhalation Toxicity)

Version / remarks:

1981

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

no

Species:

rat

Strain:

Wistar

Remarks:

Wistar rat, KFM-HAN, outbred, SPF quality

Sex:

male/female

Route of administration:

inhalation: mist

Type of inhalation exposure:

nose only

Vehicle:

air

Remark on MMAD/GSD:

MMAD has not been calculated. 47.7% of particles =< 3 um

Duration of exposure:

4 h

Concentrations:

0.78 and 5.03 mg/L

No. of animals per sex per dose:

5

Control animals:

no

Statistics:

no

Sex:

male/female

Dose descriptor:

LC0

Effect level:

5.03 mg/L air

Based on:

test mat.

Exp. duration:

4 h

Remarks on result:

other:

Remarks:

no mortality

Mortality:

No mortality occurred in males and females

Clinical signs:

other: At the concentration of 5.03 mg/L, some excitement was noted during exposure. Slight breathing difficulty (males and females) and piloerection (males only) were noted just after exposure.

Body weight:

no data

Gross pathology:

No abnormal observations were made in an of any groups.

Interpretation of results:

GHS criteria not met

Conclusions:

The acute 4-hour inhalation toxicity of TETRABENZYLTHIURAM DISULFIDE in rats of both sexes observed over a period of 15 days was estimated to be higher than 5.03 mg/L air

Executive summary:

One group of Wistar rats, comprising 5 males and 5 females, were exposed to 0.78 or 5.03 mg/L for 4 hours to dust of TBzTD.

No mortality occurred during the 14 day observation period. At the concentration of 5.03 mg/L, some excitement was noted during exposure. Slight breathing difficulty (males and females) and piloerection (males only) were noted just after exposure. No clinical signs were observed in animal treated with 0.78 mg/L.

Post-mortem examination of all animals at the end of the study did not reveal any changes that were considered to have arisen as a result of treatment.

Since no mortality occurred, the LC50 value for both males and females was noted as exceeding 5.03 mg/L.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating conc.

Value:

0.005 mg/m³ air

Quality of whole database:

The acute inhalation study is considered as reliable.

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Oral acute toxicity study

One group of Wistar rats, comprising 5 males and 5 females, received a total oral dose of Tetrabenzylthiuram disulfide at 5000 mg/kg bw (2500 mg/kg twice within 24 hours).

No mortality occurred and no signs of toxicity were observed during the 14 day observation period.

Post-mortem examination of all animals at the end of the study did not reveal any changes that were considered to have arisen as a result of treatment.

Since no mortality occurred, the oral LD50 value for both males and females was noted as exceeding 5000 mg/kg bodyweight.

Inhalation acute toxicity

One group of Wistar rats, comprising 5 males and 5 females, were exposed to 0.78 or 5.03 mg/L for 4 hours to dust of TBzTD.

No mortality occurred during the 14 day observation period. At the concentration of 5.03 mg/L, some excitement was noted during exposure. Slight breathing difficulty (males and females) and piloerection (males only) were noted just after exposure. No clinical signs were observed in animal treated with 0.78 mg/L.

Post-mortem examination of all animals at the end of the study did not reveal any changes that were considered to have arisen as a result of treatment.

Since no mortality occurred, the LC50 value for both males and females was noted as exceeding 5.03 mg/L.

Justification for classification or non-classification

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