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Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
December 29, 1960
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods 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 402 (Acute Dermal 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
Specific details on test material used for the study:
- Description: Yellow powder
- Date of receipt: November 28, 1960

Test animals

Species:
rabbit
Strain:
not specified
Remarks:
Albino
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: Young
- Housing: Restrained in stocks for the duration of the study

Administration / exposure

Type of coverage:
occlusive
Vehicle:
water
Duration of exposure:
24 hours followed by a 14 day post-dose observation period.
Details on study design:
12 young adult albino rabbits, 2 males/group for 0.25, 1.00, 4.00, or 8.00 g/kg bw groups and 3 males/1female/group for 16.00 g/kg bw group.
Dermally dosed as 25 - 60% aqueous pastes at 0.25, 1.00, 4.00, 8.00, or 16.00 g/kg bw to approximately 1 in^2 abraded area, covered with sleeves; 24 hour treatment.
Body weights were recorded prior to initiation of the study and on day 15. Gross necropsies were performed.
Morbidity, mortality, and clinical signs were recorded for 14 days. Skin irritation was scored according to Draize.
Dressings were removed 24 hours after application and excess test substance was removed.

Results and discussion

Effect levels
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
> 16 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 dermal toxicity of the test item has been determined as greater than 16 g/kg bw.
Executive summary:

An acute dermal 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 402; 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.

Twelve young albino rabbits, 2 males/group for 0.25, 1.00, 4.00, or 8.00 g/kg bw groups and 3 males/1 female/group for 16.00 g/kg bw group were dermally dosed as 25 to 60 percent aqueous pastes, using water as the vehicle to approximately 1 in2 abraded area, covered with sleeves for a 24 hour treatment period.

Dressings were removed 24 hours after application and excess test item was removed. Morbidity, mortality, and clinical signs were recorded for 14 days. Skin irritation was scored according to Draize. Body weights were recorded prior to initiation of the study and on day 15. Gross necropsies were performed. All animals survived the 14 day post-dose observation period. The dermal LD50 for both sexes was greater than 16 g/kg bw.