C-M5

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

03 April 2007 and 06 April 2007

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted to GLP and in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do no effect the quality of the relevant results.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Reference

Name:

Unnamed

Type:

Constituent

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source:
New Zealand White rabbits were supplied by an accredited supplier.

- Age at study initiation:
Twelve to twenty weeks old.

- Weight at study initiation:
At the start of the study the animals were in the weight range of 2.0 to 3.5 kg.

- Housing:
The animals were individually housed in suspended cages.

- Diet (e.g. ad libitum):
ad libitum (Certified Rabbit Diet)

- Water (e.g. ad libitum)
ad libitum.

- Acclimation period:
At least Five days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C):
17 to 23°C

- Humidity (%):
30 to 70%

- Air changes (per hr):
The rate of air exchange was at least fifteen changes per hour.

- Photoperiod (hrs dark / hrs light):
The lighting was controlled by a time switch to give twelve hours continuous light (06:00 to 18:00) and twelve hours darkness.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: clipped

Vehicle:

water

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit):0.5 g
- Concentration (if solution): Not applicable.


VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5g of test material was moistened with 0.5 ml of distilled water.
- Concentration (if solution):Not applicable.
- Lot/batch no. (if required): Not applicable.

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: On the day of the test a suitable test site was selected on the back of each rabbit.
- % coverage:Not available
- Type of wrap if used: Test material was introduced under a 2.5 cm x 2.5 cm cotton gauze patch and placed in position on the shorn skin.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): Any residual test material removed by gentle swabbing with cotton wool soaked in distilled water.
- Time after start of exposure: 4 hours.


SCORING SYSTEM: Approximately one hour following the removal of the patches, and 24, 48 and 72 hours later, the test sites were examined for evidence of primary irritation and scored according to the following scale (table below).

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

other: Erythema/Eschar Formation

Basis:

animal: 66107 male

Time point:

other: Mean score at 24, 48 and 72 hours

Score:

0

Max. score:

0

Reversibility:

other: No evidence of skin irritation

Results 2

Irritation parameter:

other: Erythema/Eschar Formation

Basis:

animal: 66108 Male

Time point:

other: Mean at 24, 48 and 72 hours

Score:

0

Max. score:

0

Reversibility:

other: No evidence of skin irritation

Results 3

Irritation parameter:

other: Erythema/Eschar Formation

Basis:

animal: 66110 male

Time point:

other: mean at 24, 48 and 72 hours

Score:

0

Max. score:

0

Reversibility:

other: No evidence of skin irritation

Results 4

Irritation parameter:

other: Oedema Formation

Basis:

animal: 66107 male

Time point:

other: mean of 24, 48 and 72 hours

Score:

0

Max. score:

0

Reversibility:

other: No evidence of skin irritation

Results 5

Irritation parameter:

other: Oedema Formation

Basis:

animal: 66108 male

Time point:

other: mean at 24, 48 and 72 hours

Score:

0

Max. score:

0

Reversibility:

other: No evidence of skin irritation

Results 6

Irritation parameter:

other: Oedema Formation

Basis:

animal: 66110 male

Time point:

other: Mean at 24, 48 and 72 hours

Score:

0

Max. score:

0

Reversibility:

other: No evidence of skin irritation

Irritant / corrosive response data:

The individual scores for erythema/eschar and oedema are given in remarks on results including tables and figures.
No evidence of skin irritation was noted during the study.

Other effects:

Red-coloured staining was noted at all treated skin sites throughout the study. This did not affect evaluation of skin reactions.

Any other information on results incl. tables

The individual scores for erythema/eschar and oedema are given in Table1.

Table1               IndividualSkin Reactions

Skin Reaction	Observation Time	Individual Scores – Rabbit Number and Sex			Total
		66107 Male	66108 Male	66110 Male
Erythema/Eschar Formation	1 Hour	0STA	0 STA	0 STA	(0 )
	24 Hours	0 STA	0 STA	0 STA	0
	48 Hours	0 STA	0 STA	0 STA	( 0 )
	72 Hours	0 STA	0 STA	0 STA	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= Red-coloured staining

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

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.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

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 requirements of the following:

§        OECD Guidelines for the Testing of Chemicals No. 404 “Acute Dermal Irritation/Corrosion” (adopted)

§        Method B4 Acute Toxicity (Skin Irritation) of Commission Directive 2004/73/EC

A single 4-hour, semi-occluded application of the test material to the intact skin of three rabbits 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. No corrosive effects were noted.

The test material did not meet the criteria for classification as irritant according to EU labelling regulations Commission Directive 2001/59/EC.