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:
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, polydypsia, anorexia, flaking of skin at test, discolouration of skin at test site and alopecia. By the time of terminal sacrifice most animals had recovered from the major signs of toxicity.
Body weight:
9 of 35 animals showed a 2 to 17% weight reduction at the 7-day weighing.
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

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