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EC number: 231-111-4 | CAS number: 7440-02-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- December 18, 1998 to December 16, 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP Guideline Study. Body weight data at start and end of the test period were not reported.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Principles of method if other than guideline:
- Equivalent to OECD Guideline 404
- GLP compliance:
- yes
Test material
- Reference substance name:
- nickel metal
- IUPAC Name:
- nickel metal
- Reference substance name:
- Nickel
- EC Number:
- 231-111-4
- EC Name:
- Nickel
- Cas Number:
- 7440-02-0
- Molecular formula:
- Ni
- IUPAC Name:
- nickel
- Reference substance name:
- "INCO® Type 123", gray metal powder
- IUPAC Name:
- "INCO® Type 123", gray metal powder
- Reference substance name:
- NiPERA.
- IUPAC Name:
- NiPERA.
- Details on test material:
- - Name of test material (as cited in study report): INCO(R) Type 123 Nickel Powder
- Molecular formula (if other than submission substance): Not different than submission substance
- Molecular weight (if other than submission substance): Not different than submission substance
- Smiles notation (if other than submission substance): Not different than submission substance
- InChl (if other than submission substance): Not different than submission substance
- Structural formula attached as image file (if other than submission substance): Not different than submission substance
- Substance type: Solid
- Physical state: Gray powder
- Lot/batch No.: 347-2165
- Storage condition of test material: Stored at room temperature
- All other details on test material not reported or not applicable
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Myrtle's Rabbitry, Thompson Station, TN, USA.
- Age at study initiation: Adult, age not reported
- Weight at study initiation: 2.0 - 3.5 kg
- Housing: housed individually in suspended stainless steel cages
- Diet (e.g. ad libitum): ad libitum (PMI Certified Rabbit Chow #5322, Purina Mills, Inc.)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: minimum of 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21 deg.C
- Humidity (%): 20-50%
- Air changes (per hr): 10-15 air changes/hour
- Photoperiod (hrs dark / hrs light): 12-hr light/12-hr dark cycle
IN-LIFE DATES: From: December 18, 1998 To: December 24, 1998
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: close-clipping
- Vehicle:
- water
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g Nickel Powder
- Concentration (if solution): 100% Nickel Powder
VEHICLE
- Amount(s) applied (volume or weight with unit): Nickel powder was moistened with 4 drops of deionized water to form a paste
prior to administration.
- Concentration (if solution): Not reported
- Lot/batch no. (if required): Not reported
- Purity: Not reported - Duration of treatment / exposure:
- 4 hour(s)
- Observation period:
- up to 72 hours
- Number of animals:
- 1 Female (3-minute period)
1 Female (1-hour period)
1 Female, 2 Males (4-hour period) - Details on study design:
- TEST SITE
- Area of exposure: Approximately 24 hours pre-exposure, a patch of fur on the dorsal trunk area of three test animals was removed by close-clipping. One test animal had 3 separate skin sites prepared.
- % coverage: Not reported
- Type of wrap if used: The test substance (0.5 g moistened with deionized water) was applied to the
patches of exposed skin via a semi-occlusive gauze patch (1 inch by 1 inch square of 4-ply gauze patch) . The patches were kept in contact with
the skin for periods of 3 minutes, 1 hour, and 4 hours, respectively for the animal with 3 exposure sites), and 4 hours (for the remaining animals
with a single exposure site).
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Residual test article was removed using gauze moistened with deionized water, followed by dry gauze.
- Time after start of exposure: 4 hours
SCORING SYSTEM: The exposed skin sites were observed and evaluated for up to 72 hours following application. Animals were observed twice daily, and unusual observations and/or mortality were recorded. Animals were examined for signs of erythema and edema, and reactions were scored
according to the Macroscopic Dermal Grading System based on the work of Draize (1959). The 4-hour exposure data were classified according to
EEC guidelines (1983) and mean scores were calculated to obtain Primary Irritation Indexes (PIIs) for erythema and edema.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 3 minutes or 1 or 4 hours
- Score:
- 0.5
- Reversibility:
- fully reversible
- Remarks on result:
- other: nonirritant
- Irritation parameter:
- erythema score
- Remarks:
- after 4 hr exposure
- Basis:
- animal: 52671
- Remarks:
- female
- Time point:
- other: 1 hr
- Score:
- 0
- Irritation parameter:
- erythema score
- Remarks:
- after 4 hr exposure
- Basis:
- animal: 52671
- Remarks:
- female
- Time point:
- 24 h
- Score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Remarks:
- after 4 hr exposure
- Basis:
- animal: 52671
- Remarks:
- female
- Time point:
- 48 h
- Score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Remarks:
- after 4 hr exposure
- Basis:
- animal: 52671
- Remarks:
- female
- Time point:
- 72 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Remarks:
- after 4 hr exposure
- Basis:
- animal: 52725
- Remarks:
- male
- Time point:
- other: 1 hr
- Score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Remarks:
- after 4 hr exposure
- Basis:
- animal: 52725
- Remarks:
- male
- Time point:
- 24 h
- Score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Remarks:
- after 4 hr exposure
- Basis:
- animal: 52725
- Remarks:
- male
- Time point:
- 48 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Remarks:
- after 4 hr exposure
- Basis:
- animal: 52725
- Remarks:
- male
- Time point:
- 72 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Remarks:
- after 4 hr exposure
- Basis:
- animal: 52727
- Remarks:
- male
- Time point:
- other: 1 hr
- Score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Remarks:
- after 4 hr exposure
- Basis:
- animal: 52727
- Remarks:
- male
- Time point:
- 24 h
- Score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Remarks:
- after 4 hr exposure
- Basis:
- animal: 52727
- Remarks:
- male
- Time point:
- 48 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Remarks:
- after 4 hr exposure
- Basis:
- animal: 52727
- Remarks:
- male
- Time point:
- 72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 3 minutes or 1 or 4 hours
- Score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- other: nonirritant
- Irritation parameter:
- edema score
- Remarks:
- after 4 hr exposure
- Basis:
- animal: 52671
- Remarks:
- female
- Time point:
- other: 1 hr
- Score:
- 0
- Irritation parameter:
- edema score
- Remarks:
- after 4 hr exposure
- Basis:
- animal: 52671
- Remarks:
- female
- Time point:
- 24 h
- Score:
- 0
- Irritation parameter:
- edema score
- Remarks:
- after 4 hr exposure
- Basis:
- animal: 52671
- Remarks:
- female
- Time point:
- 48 h
- Score:
- 0
- Irritation parameter:
- edema score
- Remarks:
- after 4 hr exposure
- Basis:
- animal: 52671
- Remarks:
- female
- Time point:
- 72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Remarks:
- after 4 hr exposure
- Basis:
- animal: 52725
- Remarks:
- male
- Time point:
- other: 1 hr
- Score:
- 0
- Irritation parameter:
- edema score
- Remarks:
- after 4 hr exposure
- Basis:
- animal: 52725
- Remarks:
- male
- Time point:
- 24 h
- Score:
- 0
- Irritation parameter:
- edema score
- Remarks:
- after 4 hr exposure
- Basis:
- animal: 52725
- Remarks:
- male
- Time point:
- 48 h
- Score:
- 0
- Irritation parameter:
- edema score
- Remarks:
- after 4 hr exposure
- Basis:
- animal: 52725
- Remarks:
- male
- Time point:
- 72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Remarks:
- after 4 hr exposure
- Basis:
- animal: 52727
- Remarks:
- male
- Time point:
- other: 1 hr
- Score:
- 0
- Irritation parameter:
- edema score
- Remarks:
- after 4 hr exposure
- Basis:
- animal: 52727
- Remarks:
- male
- Time point:
- 24 h
- Score:
- 0
- Irritation parameter:
- edema score
- Remarks:
- after 4 hr exposure
- Basis:
- animal: 52727
- Remarks:
- male
- Time point:
- 48 h
- Score:
- 0
- Irritation parameter:
- edema score
- Remarks:
- after 4 hr exposure
- Basis:
- animal: 52727
- Remarks:
- male
- Time point:
- 72 h
- Score:
- 0
- Irritant / corrosive response data:
- 3-Minute Exposure Period (1 animal): no dermal irritation observed.
All erythema and edema scores = 0 (observations made at 0, 24, 48, and 72 hours post-exposure).
1-Hour Exposure Period (1 animal): no dermal irritation observed.
Erythema scores = 1 (for observations at 0, 24, and 48 hours) and 0 (for observation at 72 hours).
All edema scores = 0 (all observations). Skin at the test site was discolored (green), possibly due to the test
substance (observed at 0, 24, and 48 hours).
4-Hour Exposure Period (3 animals): very slight dermal irritation observed.
Erythema scores = 1 (for animal #1 at 24 and 48 hours, and animals #2 and #3 at 1 and 24 hours) and 0 (for all animals at 72 hours).
All edema scores = 0 (for all animals at all observations). For all 3 animals (at 1, 24, and 48 hours), and 2 of the 3 animals (at 72 hours),
skin at the test site was discolored (green), possibly due to the test substance. Additionally, irritation outside of the test site was
noticed occasionally, probably due to the binding tape material rather than the test substance.
Mean erythema score = 0.50 (nonirritant)
Mean edema score = 0.00 (nonirritant)
Under the conditions of the test, there was no evidence that INCO® Type 123 nickel powder was corrosive to the exposed skin of
male and female adult New Zealand White rabbits during exposure periods of 3 minutes, or 1 or 4 hours. - Other effects:
- None reported
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of the test, there was no evidence that INCO® Type 123 nickel powder was corrosive to the exposed skin of male and female
adult New Zealand White rabbits during exposure periods of 3 minutes, or 1 or 4 hours. - Executive summary:
STUDY RATED BY AN INDEPENDENT REVIEWER.
ROBUST SUMMARY DEVELOPED BY AN INDEPENDENT REVIEWER.
Robust Summary for SLI (1999):
The potential irritant/corrosive effects of nickel powder were evaluated using male and female adult New Zealand White rabbits, obtained fromMyrtle's Rabbitry, Thompson Station, TN, USA. Test animals were individually housed under constant conditions of temperature (19-21 deg.C),
relative humidity (20-50%), and photoperiod (12-hr light/dark cycle). Food and water were provided ad libitum.
Approximately 24 hours pre-exposure, a patch of fur on the dorsal trunk area of three test animals was removed by close-clipping. One testanimal had 3 separate skin sites prepared. The test substance (0.5 g moistened with deionized water) was applied to the patches of exposed
skin via a semi-occlusive gauze patch. The patches were kept in contact with the skin for periods of 3 minutes, 1 hour, and 4 hours, respectively
for the animal with 3 exposure sites), and 4 hours (for the remaining animals with a single exposure site).
After the respective exposure periods, the patches were removed and residual test material was removed with water. The exposed skin siteswere observed and evaluated for up to 72 hours following application. Animals were observed twice daily, and unusual observations and/or
mortality were recorded. Animals were examined for signs of erythema and edema, and reactions were scored according to the Macroscopic Dermal
Grading System based on the work of Draize (1959). The 4-hour exposure data were classified according to EEC guidelines (1983) and mean scores
were calculated to obtain Primary Irritation Indexes (PIIs) for erythema and edema.
3-Minute Exposure Period (1 animal): no dermal irritation observed. All erythema and edema scores = 0 (observations made at 0, 24, 48, and 72hours post-exposure).
1-Hour Exposure Period (1 animal): no dermal irritation observed. Erythema scores = 1 (for observations at 0, 24, and 48 hours) and 0(for observation at 72 hours). All edema scores = 0 (all observations). Skin at the test site was discolored (green), possibly due to the test
substance (observed at 0, 24, and 48 hours).
4-Hour Exposure Period (3 animals): very slight dermal irritation observed. Erythema scores = 1 (for animal #1 at 24 and 48 hours, andanimals #2 and #3 at 1 and 24 hours) and 0 (for all animals at 72 hours). All edema scores = 0 (for all animals at all observations).
For all 3 animals (at 1, 24, and 48 hours), and 2 of the 3 animals (at 72 hours), skin at the test site was discolored (green),possibly due to the test substance. Additionally, irritation outside of the test site was noticed occasionally, probably due to the binding tape
material rather than the test substance.
Mean erythema score = 0.50 (nonirritant)
Mean edema score = 0.00 (nonirritant)
Under the conditions of the test, there was no evidence that INCO® Type 123 nickel powder was corrosive to the exposed skin of male and femaleadult New Zealand White rabbits during exposure periods of 3 minutes, or 1 or 4 hours.
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