Pentasodium 2,2'-((2,4-diamino-5-(4-methoxy-2-sulfophenylazo)-1,3-phenylene)bis(azo))bis(5-(2-(sulfonatooxyethyl)sulfonyl)benzenesulfonate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From May 03, 2006 to May 06, 2006

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

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

475-300-1

EC Name:

-

Cas Number:

910030-59-0

Molecular formula:

Hill formula: C29H25N8Na5O22S7 CAS formula: C29H30N8O22S7.5Na

IUPAC Name:

Pentasodium 2,2'-((2,4-diamino-5-(4-methoxy-2-sulfophenylazo )-1,3-phenylene)bis(azo))bis(5-(2-(sulfonatooxyethyl)sulfony l)benzenesulfonate

Test material form:

solid: particulate/powder

Details on test material:

see below

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, Császár út 135, Hungary
- Animal health: Only animals in acceptable health condition were used for the test.
- Age of animals at arrival: 11 weeks old, adult albino rabbit
- Body weight range at treatment: 2639-3118 g (i.e., at the beginning of the study); 2720-3240 g (i.e., at the end of the study)
- Housing: Animals were housed individually in metal cages
- Diet: PURINA Base – Lap gr. diet for rabbit, ad libitum
- Water: Tap water from self-service watering system, ad libitum
- Acclimation period: Male: 8 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
- Humidity: 30-70%
- Photoperiod: 12 h light/dark cycle

IN-LIFE DATES: From: To: May 03, 2006 to May 06, 2006

Test system

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

water

Remarks:

moistened with water to form a paste

Controls:

yes, concurrent no treatment

Amount / concentration applied:

500 mg (i.e., 0.5 g)

Duration of treatment / exposure:

4 h

Observation period:

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

Number of animals:

3 males

Details on study design:

PREPARATION OF THE TEST SUBSTANCE
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 (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: 4 h

REMOVAL OF TEST SUBSTANCE
After the treatment period the rest of the test substance was removed with body temperature water.

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 two weeks, the duration of the study was sufficient to evaluate fully the reversibility or irreversibility of the effects observed.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: 1, 2, and 3

Remarks:

(mean score)

Time point:

24/48/72 h

Score:

0.66

Max. score:

4

Reversibility:

fully reversible within: 72 h

Remarks:

very slight erythema at 24 and 48 h

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

edema score

Basis:

animal: 1, 2, and 3

Remarks:

(mean score)

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

1 h after the patch removal in all animals very slight erythema appeared on the treated skin surface.
24 and 48 h after the patch removal the observed signs did not change when compared to the previous observation.
72 h after the patch removal no primary irritation symptoms, like erythema and oedema or other signs occurred on the treated skin surfaces, so the study was terminated at this time.
During the study the control area was symptom-free.

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:

GHS criteria not met

Conclusions:

Under the test conditions, the test substance was considered to be slightly irritating to skin but all signs were fully reversible within 72 h. The substance is not classifiable according to CLP criteria.

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 with water was applied to an approximately 6 cm² area of intact skin. Sterile gauze pads (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 60 minutes, and at 24, 48 and 72 h.

 

Except for very slight erythema at 24 h and 48 h, no other signs of irritation were observed in treated animals during the observation period. Also, the observed erythema was reversible with 72 h. Further, mean scores for dermal irritation for each animal were calculated to be 0.66 for erythema and 0.00 for edema formation. In addition, no clinical signs of systemic toxicity were observed.