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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
December 1998 to December 1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP 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:
1999
Report Date:
1999

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Principles of method if other than guideline:
According to OECD Guideline 404 (Acute Dermal Irritation / Corrosion).
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Nickel Sulfate Hexahydrate (10101-97-0)
- 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: Pure product
- Physical state: blue-green crystalline powder
- Analytical purity: not reported
- Lot/batch No.: 08516TQ
- Stability under test conditions: not reported
- Storage condition of test material: stored at room temperature
- Other details not reported or not applicable

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source:  Myrtle's Rabbitry, Thompson Station, TN, USA
- Age at study initiation: adult
- Weight at study initiation: not reported
- Housing: individually housed
- Diet (e.g. ad libitum): ad libitum
- 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): not reported
- Photoperiod (hrs dark / hrs light): 12-hr light/dark cycle

IN-LIFE DATES: not reported

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

VEHICLE
- Amount(s) applied (volume or weight with unit): 4 drops of deionized water
Duration of treatment / exposure:
4 hour(s)
Observation period:
up to 72 hours
Number of animals:
3
Details on study design:
TEST SITE:
Approximately 24 hours pre-exposure, a patch of fur on the dorsal trunk area of three test animals was removed by close-clipping.  
One animal had 3 separate skin sites prepared.  The test substance (0.5 g moistened with deionized water) was applied to the 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 only a single exposure site).

REMOVAL OF TEST SUBSTANCE:
- Washing (if done): After the respective exposure periods, the patches were removed and residual test material was removed using water.  
- 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 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: 4-hour exposure
Score:
0.42
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 4-hour exposure
Score:
0
Reversibility:
fully reversible
Irritant / corrosive response data:
Exposure to the test substance for 3 minutes produced no dermal irritation.
Exposure to the test substance for 1 hour produced very slight erythema, which resolved completely by 48 hours.
Exposure to the test substance for 4 hours produced very slight erythema on 3/3 test animals one hour following patch removal.  
The dermal irritation observed resolved completely in all test animals by the 48-h scoring interval.
Under the conditions of the test, there was no evidence that nickel sulfate hexahydrate was corrosive to the exposed skin of male and female 
adult New Zealand White rabbits during exposure periods of 3 minutes, 1 hour, or 4 hours.
Other effects:
none reported

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information
Conclusions:
Classification: not irritating
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 the test substance were evaluated using male and female adult New Zealand White rabbits, obtained  

from Myrtle'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 animal had  

3 separate skin sites prepared.  The test substance (0.5 g moistened with deionized water) was applied to the 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 only a single exposure site).

After the respective exposure periods, the patches were removed and residual test material was removed using water.  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 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.

Exposure to the test substance for 3 minutes produced no dermal irritation.


Exposure to the test substance for 1 hour produced very slight erythema, which resolved completely by 48 hours.

Exposure to the test substance for 4 hours produced very slight erythema on 3/3 test animals one hour following patch removal.  The dermal  

irritation observed resolved completely in all test animals by the 48-h scoring interval.

Mean erythema score = 0.42 (nonirritant)
Mean edema score = 0.00 (nonirritant)

Under the conditions of the test, there was no evidence that nickel sulfate hexahydrate was corrosive to the exposed skin of male and female  

adult New Zealand White rabbits during exposure periods of 3 minutes, 1 hour, or 4 hours.