Registration Dossier
Registration Dossier
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EC number: 235-715-9 | CAS number: 12607-70-4
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- August 15 - 18, 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline Study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- [carbonato(2-)]tetrahydroxytrinickel
- EC Number:
- 235-715-9
- EC Name:
- [carbonato(2-)]tetrahydroxytrinickel
- Cas Number:
- 12607-70-4
- Molecular formula:
- Ni3(OH)4CO3
- IUPAC Name:
- trinickel monocarbonate tetrahydroxide
- Details on test material:
- - Name of test material (as cited in study report): Nickel hydroxycarbonate
- Physical state: green powder mixed to a dry paste (50% w/w mixture in distilled water)
- Analytical purity: 100%
- Lot/batch No.: Code #N109A-PTL
- Soluble in water: 34.5 mg/L (pH 6), 7.1 mg/L (pH 8).
- Stability: Test substance was expected to be stable for the duration of testing.
- Storage condition of test material: kept closed under nitrogen
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: New Zealand Albino
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Robinson Services, Inc. Clemmons, NC on August 6, 2008.
- Age at study initiation: Young adult.
- Weight at study initiation: not reported
- Housing: singly housed in suspended stainless steel caging with mesh floors
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 9 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21°C
- Humidity (%): 60-77%
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12-hour light/dark cycle
IN-LIFE DATES: August 15 - 18, 2008
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): Five-tenths of a gram of the test substance (1.0 g of the test mixture) was placed on a 1-inch x 1-inch, 4-ply gauze pad and applied to one 6-cm^2 intact dose site on each animal.
VEHICLE
- Prior to application, the test substance was moistened with distilled water to achieve a dry paste by preparing a 50% w/w mixture. - Duration of treatment / exposure:
- 4 hours
- Observation period:
- approximately 30-60 minutes, 24, 48, and 72 hours after patch removal.
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm^2
- % coverage: 100
- Type of wrap if used: gauze pad
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the test sites were gently cleansed of any residual test substance.
- Time after start of exposure: after 4 hours exposure.
SCORING SYSTEM: Draize scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 30-60 min
- Score:
- 1
- Reversibility:
- fully reversible within: 72 hrs
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 24 hrs
- Score:
- 0.7
- Reversibility:
- fully reversible within: 72 hrs
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 48 hrs
- Score:
- 0.3
- Reversibility:
- fully reversible within: 72 hrs
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 72 hrs
- Score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 30-60 min, 24, 48, and 72 hrs
- Score:
- 0.5
- Reversibility:
- fully reversible within: 72 hrs
- Irritation parameter:
- erythema score
- Basis:
- animal: 3501
- Time point:
- other: 30-60 min
- Score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal: 3501
- Time point:
- 24 h
- Score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal: 3501
- Time point:
- 48 h
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal: 3501
- Time point:
- 72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal: 3502
- Time point:
- other: 30-60 min
- Score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal: 3502
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal: 3503
- Time point:
- other: 30-60 min
- Score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal: 3503
- Time point:
- 24/48 h
- Score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal: 3503
- Time point:
- 72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal: 3501
- Time point:
- other: 30-60 min
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal: 3501
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal: 3502
- Time point:
- other: 30-60 min
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal: 3502
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal: 3503
- Time point:
- other: 30-60 min
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal: 3503
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- The Primary Dermal Irritation Index for nickel hydroxycarbonate is 0.5.
- Other effects:
- All animals appeared active and healthy during the study. Apart from the dermal irritation noted below, there were no other signs of gross toxicity, adverse pharmacologic effects, or abnormal behavior. There was no edema observed at any treated site during this study. Within one hour of patch
removal, all three treated sites exhibited very slight erythema. The overall incidence and severity of irritation decreased with time. All animals were free ofderrnal irritation by 72 hours.
Applicant's summary and conclusion
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: US EPA pesticides
- Conclusions:
- Under the conditions ofthis study, nickel hydroxycarbonate is classified as slightly irritating to the skin.
- Executive summary:
Eurofins Product Safety Laboratory (EPSL 2008) conducted a primary skin irritation test with rabbits to assess the potential for nickel hydroxycarbonate to cause irritation following a single topical application (carried out according to OECD Procedure 326 guidelines and using GLP standards). Nickel hydroxycarbonate was applied as a dry paste (0.5 g in a 50/50 w/w mixture in distilled water) to the clipped skin of three healthy, female white rabbits for 4 hours. After the 4-hour exposure, the Draize method was used to assess dermal irritation at approximately 30-60 minutes; 24, 48, and 72 hours. At 30-60 minutes after patch removal, all three animals demonstrated very slight erythema at the treatment site, but no edema was observed. Overall severity and incidence of irritation was found to decrease with time. No erythema or irritation was evident in any of the animals by 72 hours. The three animals appeared healthy and active during the study. Other than dermal irritation, no other signs of abnormal behavior, gross toxicity, or adverse pharmacologic effects were observed. The Primary Dermal Irritation Index calculated for nickel hydroxycarbonate was 0.5, and the substance was classified as slightly irritating to the skin. STUDY RATED BY AN INDEPENDENT REVIEWER
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