Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report date:
1984

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EPA OPP 81-2 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
Weight range was exceeded; occlusive dressing was used
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Potassium dimethyldithiocarbamate
EC Number:
204-875-1
EC Name:
Potassium dimethyldithiocarbamate
Cas Number:
128-03-0
Molecular formula:
C3H7NS2.K
IUPAC Name:
potassium (dimethylcarbamothioyl)sulfanide
Details on test material:
- Name of test material (as cited in study report): Busan 85
- Physical state: Green liquid
- Composition of test material, percentage of components: 52.11% KDDC
- Lot/batch No.: 4-10129
- Stability under test conditions: guaranteed by the sponsor

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Tarvins Rabbitree, Jacksonville, Arkansas, USA
- Age at study initiation: 2-5 months
- Weight at study initiation: 2.0-3.5 kg

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- % coverage: 10
- Type of wrap if used: occlusive


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.65, 1.62, 2.57, 3.24 mL/kg bw
- Concentration (if solution): undiluted
- Constant volume or concentration used: no
Duration of exposure:
24 h
Doses:
794, 1995, 3162, 3981 mg/kg bw
No. of animals per sex per dose:
5 per sex (low dose: 3 female/7 male)
Control animals:
not required
Details on study design:
Observations for death or overt signs of toxicity were made in 2 hours-intervals on the day of dosing, then once daily for fourteen days
Body weights: prior to application of the test material on Day 0 and on Days 7 and 14.
Necropsy: at scheduled sacrifice
Statistics:
LD50 was determined using Statistical Analysis System (SAS) PROBIT procedure

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
2 990 mg/kg bw
95% CL:
2 081 - 4 111
Sex:
female
Dose descriptor:
LD0
Effect level:
>= 3 162
Mortality:
794 mg/kg: 0/7(m), 0/3(f)
1995 mg/kg: 1/5(m), 0/5(f)
3162 mg/kg: 3/5(m), 0/5(f)
3981 mg/kg: 4/5(m)
Clinical signs:
other: Signs of systemic toxicity noted were (in decreasing order of incidence): rhinorrhea, yellow nasal discharge, ocular and/or oral discharge, loose stool/diarrhea, salivation, dyspnea/wheezing, lacrimation, lethargy, emaciation. Less commonly were ataxia, p
Gross pathology:
No treatment-related abnormalities were noted.

Any other information on results incl. tables

Table A6_1_2-1.             Mortality after administration of Busan 85

Dose [mg/kg]

Volume Dosage [ml/kg]

Mortality

Male

Female

794

0.65

0/7

0/3

1995

1.62

1/5

0/5

3162

2.57

3/5

0/5

3981

3.24

4/5

---

LD50 [mg/kg]

2990

>3162

Applicant's summary and conclusion