Registration Dossier
Registration Dossier
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EC number: 237-696-2 | CAS number: 13927-77-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 29 Oct 1985 to 3 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 guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: Toxic Substances Control Act Draft Guidelines; Office of Toxic Substances; Office of Pesticides and Toxic Substances; United States Environmental Protection Agency; August 1982; Acute Exposure, Primary Dermal Irritation.
- GLP compliance:
- not specified
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: Green, powder
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Froxfield Rabbits, Petersfield, Hampshire, England
- Age at study initiation: 9-13 weeks
- Weight at study initiation: 1.9-3.1 kg
- Housing: The rabbits were individually housed in metal cages with perforated floors.
- Diet: SDS Standard Rabbit Diet, ad libitum
- Water: tap water, ad libitum
ENVIRONMENT
- Temperature (°C): 19
- Humidity (%): 30-70
- Air changes (per hr): 19
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- A 0.5 g amount of the test substance was applied under a 2.5 cm square gauze pad moistened with 0.5 mL saline to two intact and two abraded skin sites on each animal.
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 5 day
- Number of animals:
- 6 females
- Details on study design:
- TEST SITE
- Approximately 24 hours prior to application of the test substance, hair was removed with electric clippers from the dorso-lumbar region of each rabbit exposing an area of skin approximately 10 cm square.
- Immediately prior to application of the test substance, two areas of skin approximately 2.5 cm square on the right side of the spine were abraded using the tip of a scalpel blade to make minor incisions through the stratum corneum. These were not deep enough to disturb the dermis or cause bleeding. Two similar sites on the left side remained intact.
- The treatment sites were occluded with "Elastoplast" elastic adhesive dressing for approximately 24 hours. "Elizabethan collars" were placed on each animal in order to prevent the animal from disturbing the test sites. The animals were not restrained during thee exposure period and were returned to their cages.
REMOVAL OF TEST SUBSTANCE
At the end of the exposure period the semi-occlusive dressing and gauze pads were removed and the treatment sites wiped to remove any residual test substance.
OBERVATIONS AND SCORING
Examination of the treated skin sites was made approximately 30 minutes and 24, 48, 72 and 96 hours after removal of the patches.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- None of the animals showed any observable response to treatment throughout the 5-day observation period.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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