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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:
22 November 1996 - 6 December 1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study according to OECD Guideline

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
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): NICKELSULFAMATE-4-HYDRATE
- Physical state: green crystalline solid
- Lot/batch No.: 61210
- Storage condition of test material: ambient temperature « 25 0 C), stored under artificial light

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: David Percival Ltd, Moston, Sandbach, Cheshire, UK
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.40-2.53 kg
- Housing: individual susppended metal cages
- Diet (e.g. ad libitum): free access
- Water (e.g. ad libitum): free access
- Acclimation period: minimum 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-19 C
- Humidity (%): 46-64%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

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):0.5g
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 ml water
Duration of treatment / exposure:
4 hours
Observation period:
14 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: surgical adhesive tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): gentle swabbing with cotton wool soaked in water
- Time after start of exposure: 4 hours

SCORING SYSTEM: according to the following scale from Draize J H, (1977) "Dermal and Eye Toxicity Tests" In: Principles and Procedures for Evaluating the Toxicity of Household Substances, National Academy of Sciences, Washington DC p.31.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
1.8
Reversibility:
fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
animal: 4
Time point:
other: 1 hr
Score:
2
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal: 4
Time point:
24/48 h
Score:
2
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal: 4
Time point:
72 h
Score:
1
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal: 4
Time point:
7 d
Score:
0
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal: 4
Time point:
14 d
Score:
0
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal: 10
Time point:
other: 1 hr
Score:
2
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal: 10
Time point:
24/48/72 h
Score:
2
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal: 10
Time point:
7 d
Score:
1
Reversibility:
fully reversible
Remarks on result:
other: crust formation
Irritation parameter:
erythema score
Basis:
animal: 10
Time point:
14 d
Score:
0
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal: 11
Time point:
other: 1 hr
Score:
1
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal: 11
Time point:
24/48 h
Score:
1
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal: 11
Time point:
72 h
Score:
0
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal: 11
Time point:
7 d
Score:
0
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal: 11
Time point:
14 d
Score:
0
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal: 4
Time point:
other: 1 hr
Score:
1
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal: 4
Time point:
24/48 h
Score:
1
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal: 4
Time point:
72 h
Score:
0
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal: 4
Time point:
7 d
Score:
0
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal: 4
Time point:
14 d
Score:
0
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal: 10
Time point:
other: 1 hr
Score:
1
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal: 10
Time point:
24/48/72 h
Score:
1
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal: 10
Time point:
7 d
Score:
0
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal: 10
Time point:
14 d
Score:
0
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal: 11
Time point:
other: 1 hr
Score:
1
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal: 11
Time point:
24/48/72 h
Score:
0
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal: 11
Time point:
7 d
Score:
0
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal: 11
Time point:
14 d
Score:
0
Reversibility:
fully reversible
Irritant / corrosive response data:
No corrosive effects were noted
Other effects:
Very slight to well-defined erythema and very slight oedema observed.
Crust formation was also noted at one treated skin site.

Any other information on results incl. tables

Well-defined erythema was noted at two treated skin sites with very slight erythema at the remaining treated skin site one hour after patch removal and at the subsequent 24 and 48-hour observations. Well-defined erythema was noted at one treated skin site with very slight erythema at one other treated skin site at the 72-hour observation. Very slight erythema was noted at one treated skin site at the 7-day observation. No other evidence of erythema was noted. Very slight oedema was noted at all treated skin sites one hour after patch removal, at two treated skin sites at the 24 and 48-hour observations and persisted at one treated skin site at the 72-hour observation. No other evidence of oedema was noted. Crust formation was noted at one treated skin site at the 7-day observation. Treated skin sites appeared normal at the 14-day observation.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information