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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Guideline study performed in compliance with GLP, available as unpublished report, no restrictions, fully adequate for assessment.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

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)

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:
Signs of toxicity related to dose levels:
No signs of systemic toxicity were observed during the observation period.
Body weight:
All animals showed bodyweight gain.
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.

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