Tetrakis(phenylmethyl)thioperoxydi(carbothioamide)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

December 23, 1987to March 14, 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Guideline study performed in compliance with GLP, available as unpublished report, no restrictions, fully adequate for assessment.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 EEC 84/449, Annex V, B.1

Deviations:

no

Principles of method if other than guideline:

Directive 84/449/EEC was replaced by Directive 92/69/EEC and REGULATION (EC) No 440/2008.
Equivalent to OECD 401

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

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:

N,N-dibenzyl[(dibenzylcarbamothioyl)disulfanyl]carbothioamide

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

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

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

methylcellulose

Details on oral exposure:

VEHICLE
- Concentration in vehicle: Substance delivered in 1% aqueous methyl cellulose.

MAXIMUM DOSE VOLUME APPLIED: The dose volume was 10 ml/kg bodyweight on each occasion, instead of twice 7.5 ml/kg as mentioned in the study protocol. This was not considered to have adversely affected the outcome .of the study.

Doses:

The dose level was 5000 mg/kg bodyweight and was administered as two doses of 2500 mg/kg within 24 hours.

No. of animals per sex per dose:

Based on the absence of mortality observed in the pilot study, one group of animals, comprising 5 males and 5 females was dosed with a total oral dose of test substance at 5000 mg/kg bodyweight (2500 mg/kg twice within 24 hours)

Control animals:

no

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

Male: 5000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 5000 mg/kg bw; Number of animals: 5; Number of deaths: 0

Clinical signs:

other: Signs of toxicity related to dose levels: No signs of systemic toxicity were observed during the observation period.

Gross pathology:

Effects on organs:
No effects on organs were found after sacrifice on day 15.

Applicant's summary and conclusion

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. bodyweight (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.