Dialuminium nickel tetraoxide

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

GLP - Guideline study, tested with CAS number 1313-99-1. In accordance to the ECHA guidance document “Practical guide 6: How to report read-across and categories (March 2010)”, the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Report date:

2008

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Nickel monoxide

EC Number:

215-215-7

EC Name:

Nickel monoxide

Cas Number:

1313-99-1

IUPAC Name:

oxonickel

Details on test material:

- Substance type: Nickel oxide sinter (Nickel oxide green)
- Physical state: dark grey, oderless granules
- Composition of test material, percentage of components: 98% NiO; 1.5% Colbaltous Oxide
- Lot/batch No.: Code #N112-PTL
- Expiration date of the lot/batch:Not applicable
- Stability under test conditions: Test substance was expected to be stable for the duration of testing
- Storage condition of test material: kept in a tightly closed container under nitrogen
- Other:insoluble in water

Test animals

Species:

rabbit

Strain:

other: New Zealand albino

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Received from Robinson Services, Inc. Clemmons, NC on August 20,2008
- Age at study initiation: young adult
- Housing:The animals were singly housed in suspended stainless steel caging with mesh floors. Litter paper was placed beneath the cage and was changed at least three times per week.
- Diet (e.g. ad libitum): Pelleted Purina Rabbit Chow #5326
- Water (e.g. ad libitum):Filtered tap water was supplied ad-libitum by an automatic water dispensing system.
- Acclimation period: 7 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-20°C
- Humidity (%): 69-84%; The humidity was above the targeted upper limit of 70% during the study due to exceptionally high, seasonal humidity. Portable dehumidifiers were used to lower the humidity levels during this time.
- Photoperiod (hrs dark / hrs light):12-hour light/dark cycle

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: clipping

Vehicle:

water

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): Five-tenths of a gram of the test substance (O.56g of the test mixture)
- Concentration (if solution):90% w/w mixture


VEHICLE
- Amount(s) applied (volume or weight with unit):test substance was moistened with in distilled water to achieve a dry paste by preparing a 90% w/w mixture
- Purity:distilled

Duration of treatment / exposure:

4 hours

Observation period:

up to 72 hours

Number of animals:

3

Details on study design:

On the day before application, a group of animals was prepared by clipping the dorsal area and the trunk. Prior to application, the animals were examined for health and the skin checked for any abnormalities. Three healthy animals were selected for test. Five-tenths of a gram of the test substance (0.56g 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. The pad and entire trunk of each animal were then wrapped with semiocclusive 3-inch Micropore tape. Elizabethan collars were placed on each rabbit. After 4 hours of exposure, the pads and the collars were removed and the test sites were gently cleansed. Individual dose sites were scored according to the Draize scoring system at approximately 30-60 minutes, 24, 48, and 72 hours after patch removal. The animals were observed for signs of gross toxicity and behavioral changes at least once daily. Observations included gross evaluation of skin and fur, eyes and mucous membranes, respiratory, circulatory, autonomic and central nervous systems, somatomotor activity and behavior pattern. Particular attention was directed to observation of tremors, convulsions, salivation, diarrhea, and coma.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 30-60 min

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 24 hours

Remarks on result:

other: Within one hour of patch removal, all three treated sites exhibited very slight erythema

Results 2

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24 hours

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24 hours

Remarks on result:

other: all three animals scored as 0

Results 3

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 48 hours

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24 hours

Results 4

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 72 hours

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24 hours

Results 5

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 30-60 min

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24 hours

Results 6

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24 hours

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24 hours

Results 7

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 48 hours

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24 hours

Results 8

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 72 hours

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24 hours

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.

Any other information on results incl. tables

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 of dermal irritation by 24 hours.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Executive summary:

Eurofins Product Safety Laboratory (EPSL) conducted a primary skin irritation study in rabbits according to OECD Test #404 - Acute Dermal Irritation/Corrosion guidelines and using GLP standards. The study was completed on 2008-10-08 and the final report issued on 2008-12-04. Three healthy female rabbits were exposed via the skin to five-tenths of a gram of Nickel oxide sinter (Nickel oxide green) (moistened with distilled water) to determine if the test substance has the potential to produce irritation. The exposed area was semi-occluded for 4 hours following application, followed by evaluation at approximately 30-60 minutes, 24, 48, and 72 hours after exposure was ceased and the application site cleansed of residual substance. Application sites were evaluated using the Draize scoring system and included assessments of erythema (scores 0-4) and edema (scores 0-4). These endpoints were then used to derive the Primary Dermal Irritation Index (PDII). Individual animal data were provided as well as average data. Erythema was noted in all test animals at the 30-60 minute time point (each animal was scored as 1), but not at the remaining time intervals (scored as 0). No edema was observed during the study (each animal scored as 0 at all time points). The overall incidence and severity decreased with time, and the effects were fully reversible within 24 hours. Aside from dermal irritation, no other signs of gross toxicity, adverse pharmacologic effects, or abnormal behavior were noted. STUDY RATED BY AN INDEPENDENT REVIEWER