Reaction mass of copper and iron and zinc

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 24 November 2005 to 02 December 2005

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Report date:

2006

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Reference

Name:

Unnamed

Type:

Constituent

Test material form:

solid: particulate/powder

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: David Percival Ltd, Moston, Sandbach, Cheshire, UK
- Age at study initiation: 12 to 20 weeks old
- Weight at study initiation: 2.0 to 3.5 kg
- Housing: individually in suspended cages
- Diet: free access
- Water: free access
- Acclimatization: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hour): 15
- Photoperiod (hours dark / hours light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

water

Remarks:

The test item was moistened with 0.5 ml of distilled water.

Amount / concentration applied:

0.5 g of the test material

Duration of treatment / exposure:

One patch was removed at each of three time points: 3 minutes, 1 hour and 4 hours after application for one rabbit initially treated. For the rest of two rabbits, one patch was allowed to remain in contact with the skin for a period of four hours. After the removal of patches, any residual test material was removed by gentle swabbing with cotton wool soaked in distilled water.

Observation period:

Approximately one hour following the removal of the patches, and 24, 48 and 72 hours later.

Number of animals:

Three rabbits

Details on study design:

Three suitable sites were selected on the back of the rabbit. The test material was introduced under a 2.5 cm x 2.5 cm cotton gauze patch and placed in position on the shorn skin. Each patch was secured in position with a strip of surgical adhesive tape. To prevent the animal interfering with the patches, the trunk of the rabbit was wrapped in an elasticated corset and the animal was returned to its cage for the duration of the exposure periods.

The scores for erythema and oedema at the 24 and 72-hour reading were totaled for the three test rabbits (12 values) and this total was divided by six to give the primary irritation index of the test material. The test material was classified according to the scheme devised by Draize JH (1959) “Dermal Toxicity” In: Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics.

Primary Irritation Index / Classification of Irritancy
0 / Non-irritant
>0 to 2 / Mild irritant
>2 to 5 / Moderate irritant
>5 to 8 / Severe irritant

If irreversible alteration of the dermal tissue is noted in any rabbit, as judged by the Study Director, which include ulceration and clear necrosis or signs of scar tissue, the test material is classified as corrosive to rabbit skin. Classification according to Draize may, therefore, not be applicable.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 3

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 4

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 5

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

No evidence of skin irritation was noted during the study.

Any other information on results incl. tables

Individual Skin Reactions following 4 - hour exposure

		Individual Scores - Rabbit Number and Sex
Skin Reaction	Observation Time	81 Male	42 Male	48 Male	Total
Erythema / Eschar Formation	1 Hour	0 STA	0	0	(0)
	24 Hours	0 STA	0	0	0
	48 Hours	0	0	0	(0)
	72 Hours	0	0	0	0
Oedema Formation	1 Hour	0	0	0	(0)
	24 Hours	0	0	0	0
	48 Hours	0	0	0	(0)
	72 hours	0	0	0	0

Sum of 24 and 72 -hour Readings (S): 0

Primary Irritation Index (S/6): 0/6 = 0.0

Classification: Non-irritant

STA-Black staining

()=Total values not sued for calculation of primary irritation index

Individual skin reaction following 1 -hour and 3 - minute exposures

		Individual Scores - Rabbit Number and Sex
		81 Male
Skin Reaction	Observation Time	1-Hour Exposure	3-Minute Exposure
Erythema /Eschar Formation	1 Hour	0	0
	24 Hours	0	0
	48 Hours	0	0
	72 Hours	0	0
Oedema Formation	1 Hour	0	0
	24 Hours	0	0
	48 Hours	0	0
	72 Hours	0	0

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test material produced a primary irritation index of 0.0 and was classified as non-irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.

Executive summary:

The study was performed to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit. The method was designed to meet the requirement of the OECD Guideline 404 and Method B4.

 

A single 4-hour, semi-occluded application of the test material to the intact skin of three rabbits produced no evidence of skin irritation.

 

3-minute and 1-hour semi-occluded applications of the test material to the intact skin of one rabbit produced no evidence of skin irritation.

 

The test material produced a primary irritation index of 0.0 and was classified as non-irritant to rabbit skin according to the Draize classification scheme.