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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
15 Nov 1985 to 29 Nov 1985
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:
1986
Report date:
1986

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
other: Toxic Substances Control Act Health Effects Guidelines; Office of Toxic Substances; Office of Pesticides and Toxic Substances; United States Environmental Protection Agency, August 1982; Acute Exposure, Oral Toxicity.
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Nickel bis(dibutyldithiocarbamate)
EC Number:
237-696-2
EC Name:
Nickel bis(dibutyldithiocarbamate)
Cas Number:
13927-77-0
Molecular formula:
C18-H36-N2-Ni-S4
IUPAC Name:
Nickel(II) Dibutyldithiocarbamate
Test material form:
solid: particulate/powder
Specific details on test material used for the study:
- Name of the test item (as cited in study report): Nickel dibutyldithiocarbamate
- Batch No.: 0131100 NF
- Appearance: Dark green, powder

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River (UK) Ltd., Manston Road, Margate, Kent, England
- Age at study initiation: 4-6 weeks
- Weight at study initiation: 291-300 g (males) and 246-250 g (females)
- Fasting period before study: overnight prior to dosing
- Housing: individually, in metal cages with wire mesh floors
- Diet: Labsure LAD 1, ad libitum
- Water: tap water, ad libitum
- Acclimation period: 7 days

ENVIRONMENT
- Temperature (°C): 20 - 22
- Humidity (%): 63
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 50% (w/v)
- Amount of vehicle (if gavage): 10 mL/kg
Doses:
5.0 g/kg bodyweight
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed soon after dosing; then at frequent intervals for the remainder of Day 1. On subsequent days the animals were observed at least twice per day. Body weights were recorded on Days 1, 2, 3, 5, 8, 11, and 15.
- Necropsy of survivors performed: yes

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:
There were no mortalities following a single oral dose of the test substance at 5.0 mg/kg bodyweight.
Clinical signs:
Pilo-erection was seen shortly after dosing in all rats. This had resolved by Day 3. No other signs of reaction to treatment were observed.
Body weight:
Bodyweight losses were recorded for three male and three female rats on Day 3 and for one female rat on Day 11. Bodyweight gains were recorded on all other occasions.
Gross pathology:
Terminal autopsy findings were normal.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met