Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
February 6, 1961
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1961
Report date:
1961

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
Conducted before implementation of OECD Guidelines for Testing of Chemicals and GLP. Species, number and sex of animals, body weight measurement, dose preparation, and treatment conditions are described. Test substance characterization and batch number are not included in the study report.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

1
Chemical structure
Reference substance name:
Reaction mass of tris(dipentyldithiocarbamato-S,S')antimony and [bis(2-ethylhexyl)dithiocarbamato-S,S']bis(dipentyldithiocarbamato-S,S')antimony and bis[bis(2-ethylhexyl)dithiocarbamato-S,S'](dipentyldithiocarbamato-S,S')antimony and tris[bis(2-ethylhexyl)dithiocarbamato-S,S']antimony
EC Number:
948-063-1
IUPAC Name:
Reaction mass of tris(dipentyldithiocarbamato-S,S')antimony and [bis(2-ethylhexyl)dithiocarbamato-S,S']bis(dipentyldithiocarbamato-S,S')antimony and bis[bis(2-ethylhexyl)dithiocarbamato-S,S'](dipentyldithiocarbamato-S,S')antimony and tris[bis(2-ethylhexyl)dithiocarbamato-S,S']antimony
Test material form:
liquid: viscous

Test animals

Species:
rat
Strain:
not specified
Remarks:
Albino
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 160 to 290 g
- Fasting period before study: 18 ± 2 hours
- Housing: Individual cages
- Diet: ad libitum
- Water: ad libitum

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
cotton seed oil
Details on oral exposure:
- Test substance: Dosed as 10 - 40% in cottonseed oil
- Vehicle: Cottonseed oil
-Test conditions: Orally dosed as 10 - 40% in cottonseed oil at 1.0, 2.1, 4.1, 8.2, 11.6, or 16.4 g/kg bw as a single dose
No. of animals per sex per dose:
3/sex/dose
Details on study design:
Morbidity, mortality, and clinical signs were recorded for 14 days. Body weights were recorded on days 0 and 14. Gross necropsies were performed.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 16.4 other: g/kg bw
Based on:
test mat.
Mortality:
All animals survived the 14 day post-dose observation period.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of the study, the LD50 for acute oral toxicity of the test item has been determined as greater than 16.4 g/kg bw.
Executive summary:

An acute oral toxicity study was performed on the Read-Across substance Antimony Dipentyldithiocarbamate. Although no guidelines were stated within the study, the methodology is similar or equivalent to the standardized OECD 401; hence the study has been assigned a Klimisch score of 2.

The study was conducted before implementation of OECD Guidelines for Testing of Chemicals and GLP. However, the species, number and sex of animals, body weight measurement, dose preparation, and treatment conditions are described; yet, test item characterization and batch number are not included in the study report.

Albino rats, (3 per sex per group, for 6 groups) were orally dosed as 10 to 40 percent in cottonseed oil at 1.0, 2.1, 4.1, 8.2, 11.6, or 16.4 g/kg bw as a single dose.

Morbidity, mortality, and clinical signs were recorded for 14 days. Body weights were recorded on days 0 and 14. Gross necropsies were performed. All animals survived the 14 day post-dose observation period. The oral LD50 for both sexes was greater than 16.4 g/kg bw.