Registration Dossier

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
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report Date:
2008

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
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

Test animals

Species:
rabbit
Strain:
other: New Zealand Albino
Details on test animals 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
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