Registration Dossier
Registration Dossier
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EC number: 237-696-2 | CAS number: 13927-77-0
Acute Toxicity: oral
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:
- 1 986
- 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
- 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
Constituent 1
- 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:
- other: 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.
- Gross pathology:
- Terminal autopsy findings were normal.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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