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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:
13/05/2003-09/06/2003
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study meets generally accepted guidlines with some limitations.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
equivalent or similar to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Nickel nitrate cryst 6H20
- Physical state: solid powder
- Lot/batch No.:81154 TQ
- Storage condition of test material: ambient temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Elevage de Gérome (Quartier Labaste - 40260 Linxe)
- Weight at study initiation:2.42-2.75 kg
- Housing: individual cages
- Acclimation period: 7-17 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23
- Humidity (%):40-64

Test system

Type of coverage:
open
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
other: other side of same 3 animals
Amount / concentration applied:
0.5g (NB: Study summary states that 50g was applied but indidual animal reports indicate 0.5g was applied).
Duration of treatment / exposure:
4 hours
Observation period:
1, 24, 48, and 72 hours after removing dresing
Number of animals:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: Primary Irritation Index: IPc
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
3.8
Max. score:
9
Reversibility:
fully reversible within: 11-13 days
Remarks on result:
positive indication of irritation
Irritation parameter:
erythema score
Basis:
animal: A5277
Time point:
24 h
Score:
2
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal: A5277
Time point:
48 h
Score:
3
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal: A5277
Time point:
72 h
Score:
3
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal: A5277
Time point:
24 h
Score:
3
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal: A5277
Time point:
48 h
Score:
2
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal: A5277
Time point:
72 h
Score:
1
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal: A5314
Time point:
24 h
Score:
3
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal: A5314
Time point:
48 h
Score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal: A5314
Time point:
72 h
Score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal: A5314
Time point:
24 h
Score:
3
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal: A5314
Time point:
48 h
Score:
0
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal: A5314
Time point:
72 h
Score:
0
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal: A5315
Time point:
24 h
Score:
2
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal: A5315
Time point:
48 h
Score:
2
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal: A5315
Time point:
72 h
Score:
2
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal: A5315
Time point:
24 h
Score:
0
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal: A5315
Time point:
48 h
Score:
0
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal: A5315
Time point:
72 h
Score:
0
Reversibility:
fully reversible
Irritant / corrosive response data:
24 hours after the application of the product, a moderate to significant erythema accompanied by an edema was noted in 2 animals. The edematous reaction was completely reversible between the 3rd and 5th day of the study and the erythematous reaction between the 3rd and 6th day of the study.
At the level of the cutaneous structure, as of the 3rd and the 6th day, the formation of a crust was observed. The skin became completely healthy between the 11th and 13th day of the study.

Applicant's summary and conclusion