Alkali salt of (sulfonato oxyethane sulfonyl) arylamino triazinylamino sulfonato (sulfonato arylazo) aryl sulfonate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From June 27, 2006 to June 30, 2006

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to OECD Guideline 404, EU Method B.4 and EPA OPPTS 870.2500 Method, in compliance with GLP

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:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): Reaktiv Rot F99-0078

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Ferenc Sandor breeder, 2173 Kartal, Csaszar ut 135, Hungary
- Date of receipt: June 20, 2006
- Age at study initiation: 10 weeks old, adult albino rabbit
- Body weight range at treatment: 2,553-2,687g (i.e., at the beginning of the study), 2,668-2,858 g (i.e., at the end of the study)
- Sex: Male.
- Housing: Animals were housed individually in metal cages
- Diet: Purina Base – Lap gr. diet for rabbit produced by Agribrands Europe Hungary PLC, H-5300 Karcag, Madarasi road, Hungary, ad libitum
- Water: Tap water from self- service water system, ad libitum
- Animal health: Only animals in acceptable health condition were used for the test.
- Acclimation period: 7 d
- Animal identification: The individual identification was performed by numbered ear tag. The cages were marked with individual identity cards with information about study code, sex, dose group, cage number and individual animal number.

ENVIRONMENTAL CONDITIONS
- Temperature: 20±3°C
- Relative humidity: 30-70%
- Photoperiod: 12 h light/dark cycle

IN-LIFE DATES: From: To: June 27, 2006 to June 30, 2006

Test system

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated skin of each animal

Amount / concentration applied:

500 mg

Duration of treatment / exposure:

4 h

Observation period:

1, 24, 48 and 72 h after the patch removal

Number of animals:

3

Details on study design:

ADMINISTRATION OF THE TEST SUBSTANCE

Dosage
The test substance was used in pure state, in a single dose. 0.5 g of test substance was applied to the test site. The test substance was moistened sufficiently with water to ensure good contact with the skin. Untreated skin of each animal served as control.

TEST PROCEDURE
Patch testing was used to detect primary irritating effects of the test substance. Three male animals in acceptable health condition were selected for this test. Each animal was examined 24 h before starting the test. Approximately 24 h prior to the test the hair was clipped from the back and flanks of the animals.
The test substance was applied to an approximately 6 cm² area of intact skin. Sterile gauze pads (i.e., 5x5 cm) were placed on the skin of rabbits. These gauze patches were kept in contact with the skin by a patch with a surrounding adhesive hypoallergenic plaster. The entire trunks of the animals were wrapped with plastic wrap for 4 h. In the first step an initial test was performed using one animal. 1 h after application of the test substance to the sentinel animal, the application site was examined. Severe irritation or corrosive effect could not be found in the initial test, therefore the bandage was replaced and the exposure continued for a further 3 h (i.e., a total 4 h exposure). Two additional animals were involved for this study.

Duration of Exposure
Duration of exposure: 4 h. After the treatment period the rest of the test substance was removed with body temperature water.

OBSERVATIONS AND SCORING

Clinical Observations
Animals were examined for signs of erythema and oedema, and the responses scored at 60 minutes and then at 24, 48 and 72 h after the patch removal. At the end of the observation period euthanasia of the animal was by intramuscular injections of Ketamin and Xylazin followed by i.v. Euthanyl anaesthesia.

Scoring and Assessment of Local Reactions
The dermal irritation scores were evaluated according to the scoring system by Draize (1959). The animals were observed for 72 h, the duration of the study was sufficient to evaluate fully the reversibility or irreversibility of the effects observed.

SCORING SYSTEM:
Erythema and eschar formation
No erythema........................................................................................................................0
Very slight erythema (barely perceptible) ......................................................................1
Well-defined erythema ......................................................................................................2
Moderate to severe erythema............................................................................................3
Severe erythema (beet redness) to slight eschar formation (injuries in depth) .......4

Oedema
No oedema..............................................................................................................................0
Very slight oedema (barely perceptible).............................................................................1
Slight oedema (edges of area well defined by definite raising).......................................2
Moderate oedema (raised approximately 1 mm) ..............................................................3
Severe oedema (raised more than 1 mm and extending beyond area of exposure)...4

Measurement of Body Weight
Body weights were recorded at the beginning and at the end of experiment.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

(mean score)

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

(mean score)

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Max. score:

4

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Remarks:

(mean score)

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Max. score:

4

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

(mean score)

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Max. score:

4

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Remarks:

(mean score)

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Max. score:

4

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Remarks:

(mean score)

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

- 1 h after the patch removal in two animals very slight oedema appeared on the treated skin surface. The erythema could not be evaluated in consequence of covered up colour of the test substance, but the possibility of the severe erythema and corrosion were precluded.
- 24, 48 and 72 h after the patch removal all animals were symptom-free, so the study was terminated 72 h after the patch removal.
- During the study the control area was symptom-free in all animals.

Other effects:

- General state and the behaviour of animals were normal throughout the study period.
- There were no notable body weight changes during the contact and observation period.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the test conditions, the test substance was not considered to be irritating to skin.

Executive summary:

A study was performed to assess the skin irritation potential of the test substance in male New Zealand White rabbits according to OECD Guideline 404, EPA OPPTS 870.2500 and EU Method B.4, in compliance with GLP.

500 mg of test substance moistened sufficiently with water was applied to an approximately 6 cm² area of intact skin. Sterile gauze pads (i.e., 5x5 cm) were placed on the skin of rabbits surrounded by an adhesive hypoallergenic plaster. The entire trunks of the animals were wrapped with plastic wrap for 4 h. After the exposure period, all remnants of test substance were carefully removed from the skin with body temperature water. Animals were scored for irritation reactions after 1, 24, 48 and 72 h.

Very slight oedema was observed in two animals at 1 h after the patch removal. Although, the erythema could not be evaluated in consequence of covered up colour of the test substance, the possibility of the severe erythema and corrosion was excluded. All animal were symptom free at 24, 48 and 72 h. Further, overall mean scores for dermal irritation were calculated to be 0.00 for erythema and 0.00 for edema formation. In addition, no clinical signs of systemic toxicity and no notable body weight changes were observed during the study period.

 

Under the test conditions, the test substance was not considered to be irritating to skin.