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Diss Factsheets

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:
2008-2009
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report date:
2009

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Principles of method if other than guideline:
not applicable
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Trinickel disulphide
EC Number:
234-829-6
EC Name:
Trinickel disulphide
Cas Number:
12035-72-2
Molecular formula:
Ni3S2
IUPAC Name:
trinickel disulfide
Details on test material:
- Name of test material (as cited in study report): nickel subsulfide
- Substance type: test substance
- Physical state: grey powder
- Composition of test material, percentage of components: 85% w/w nickel subsulfide mixture in distilled water
- Stability under test conditions: expected to be stable for the duration of testing
- Storage condition of test material: stored at ambient temperature in a tightly closed container
- Expiration date was not applicable
- Other: Code #N18A-PTL, sparingly soluble in water

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Robinson Services Inc, Clemmons NC
- Age at study initiation: young adult
- Housing: singly housed in suspended stainless steel caging with mesh floors; litter paper was placed beneath the cage and changed at least three times per week
- Diet (e.g. ad libitum): not specified; Pelleted Purina Rabbit Chow #5326.
- Water (e.g. ad libitum): ad-libitum
- Acclimation period: 7 or 70 days
- No known contaminants reasonably expected to be found in the food or water at levels that would have interfered with the results of the study.


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-20°C
- Humidity (%): 33-38%
- Photoperiod (hrs dark / hrs light): 12 hours 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 (0.59 g Ni3S2)
- Concentration (if solution): 85% w/w mixture

VEHICLE
- Amount(s) applied (volume or weight with unit): test substance was moistened to achieve a dry paste by preparing a 85% w/w mixture
- Purity: distilled
Duration of treatment / exposure:
4 h
Observation period:
72 h after patch removal (and multiple intervals within this period)
Number of animals:
3
Details on study design:
Test substace placed on a 1 inch x 1 inch, 4-ply gauze pad and applied to one 6-cm2 intact dose site. Pad and trunk of animal then wrapped with semi-occclusive 3-inch Micropore tape. Elizabethan collars placed on each rabbit during treatment. Dose sites were evaluated according to the Draize scoring system at ~30-60 minutes, 24, 48, and 72 hours after patch removal. Irritancy classification was obtained by adding the average erythema and edema scores for each interval and dividing by the number of evaluation intervals. Cage-side observations of gross toxicity and behavioral changes were conducted at least once daily during the test period. Gross observational endpoints included: skin, fur, eyes, 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.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): dose site was gently cleansed of any residual test substance after patch removal
- Time after start of exposure: 4 h

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 30-60 min
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: 2 animals scored as 1; 1 animal scored as 0
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: 1 animal scored as 1; 2 animals scored as 0
Irritation parameter:
erythema score
Basis:
mean
Time point:
48 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: 1 animal scored as 1; 2 animals scored as 0
Irritation parameter:
erythema score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: all 3 animals scored as 0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 30-60 min
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 h
Remarks on result:
other: all 3 animals scored as 0
Irritation parameter:
edema score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 h
Remarks on result:
other: all 3 animals scored as 0
Irritation parameter:
edema score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 h
Remarks on result:
other: all 3 animals scored as 0
Irritation parameter:
edema score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 h
Remarks on result:
other: all 3 animals scored as 0
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 30-60 min
Score:
0.7
Max. score:
5
Reversibility:
fully reversible within: 72 h
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
24 h
Score:
0.3
Max. score:
5
Reversibility:
fully reversible within: 72 h
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
48 h
Score:
0.3
Max. score:
5
Reversibility:
fully reversible within: 72 h
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
5
Reversibility:
fully reversible within: 72 h
Irritant / corrosive response data:
Not Applicable
Other effects:
All animals appeared active and healthy during the study. Apart from the slight dermal irritatition noted, no signs of gross toxicity, adverse pharmacologic effects, or abnormal behavior were observed.

Any other information on results incl. tables

There was no edema observed at any treated site during the study. Within one hour of patch removal, very slight erythema was noted for two of the three treated dose sites. The overall incidence and severity of irritation decreased with time. Both animals were free from dermal irritation by 72 hours. The Primary Dermal Irritation Index for Nickel subsulfide is 0.3.

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Conclusions:
Not applicable
Executive summary:

Eurofins Product Safety Laboratory (EPSL) conducted a primary skin irritation study in rabbits according to OECD Test #404 guidelines and using GLP standards. Testing was completed on 2009-01-10 and the final report issued on 2009-03-10. Three healthy female rabbits were exposed via the skin to five-tenths of a gram of nickel subsulfide (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 PDII. Individual animal data were provided as well as average data. Erythema was noted in two test animals at the 30-60 minute time point (each animal was scored as 1), one animal at the 24 hour and 48 hour timepoints (animal scored as 1), but not at the remaining time interval (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 72 hours. The resulting PDII was 0.3, indicating that nickel subsulfide was slightly irritating to the skin. Aside from dermal irritation, no other signs of gross toxicity, adverse pharmacologic effects, or abnormal behavior were noted. STUDY RATED BY AN INDEPENDENT REVIEWER