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Administrative data

acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
14 Nov 1985 to 28 Nov 1985
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference Type:
study report
Report date:

Materials and methods

Test guidelineopen allclose all
equivalent or similar to guideline
OECD Guideline 402 (Acute Dermal Toxicity)
equivalent or similar to guideline
other: Toxic Substances Control Act Health Effects Test Guidelines; Office of Toxic Substances; Office of Pesticides and Toxic Substances; United States Environmental Protection Agency, August 1982; Acute Exposure, Dermal Toxicity.
GLP compliance:
not specified
Test type:
standard acute method
Limit test:

Test material

Constituent 1
Chemical structure
Reference substance name:
Nickel bis(dibutyldithiocarbamate)
EC Number:
EC Name:
Nickel bis(dibutyldithiocarbamate)
Cas Number:
Molecular formula:
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

New Zealand White
Details on test animals or test system and environmental conditions:
- Source: Froxfield Rabbits, Petersfield, Hampshire, England
- Age at study initiation: 10-12 weeks
- Weight at study initiation: 2.3-2.7 kg
- Housing: The rabbits were housed individually in metal cages with perforated floors.
- Diet: SQC Standard Rabbit Diet, ad libitum
- Water: tap water, ad libitum
- Acclimation period: minimum of 6 days

- Temperature (°C): 20-21
- Humidity (%): 45 ± 10
- Air changes (per hr): 19
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Type of coverage:
unchanged (no vehicle)
Details on dermal exposure:
24 hours prior to treatment hair was clipped from the dorso-lumbar region of each rabbit exposing an area approximately 10% of the total body surface area. The test substance was applied by spreading evenly over the clipped treatment site in as uniform a manner as possible moistened with 2.0 mL/kg bodyweight saline. Treatment in this manner was performed on Day 1 of the study only.

After the exposure period of 24 hours the dressing was removed an the treatment site gently washed with water to remove any residual test substance. Collars were fitted on each rabbit and were worn for approximately 23 hours to prevent ingestion of any residual test substance.
Duration of exposure:
24 hours
2.0 g/kg bodyweight
No. of animals per sex per dose:
Control animals:
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: ANimals were observed soon after dosing and then at frequent intervals for the remainder of Day 1. On subsequent days the animals were observed once in the morning and once at the end of the experimental day. Body weights were recorded on Days 1, 2, 3, 5, 8, 11 and 15.
- Local dermal reactions (erythema/oedema) at the treatment site were assessed daily.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Key result
Dose descriptor:
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
There were no mortalities.
Clinical signs:
Two male rabbits were observed to have consumed little food on Days 4 and 5. Diarrhoea, was observed on Day 3 in one of these rabbits. There were no signs of systemic toxicity in the remaining 3 male or five female rabbit.
Body weight:
A bodyweight loss was recorded for two male and three female rabbits on Day 2, for four males and three female rabbits on Day 3, for one male rabbit on Day 8 and for one female rabbit on Day 11. A poor weight gain was recorded on Days 3 and 8 for one male rabbit and on Day 15 for one other male rabbit. An unchanged weight was recorded for one male rabbit on Day 2 only.
Gross pathology:
Terminal autopsy findings were normal.
Other findings:
There were no dermal reactions at the site of application in any of the rabbits, however some staining of the skin and adjacent fur, by the test substance was observed.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met