Disodium hydrogen bis[3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]naphthalene-1-sulphonato(3-)]chromate(3-)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation / corrosion, other

Remarks:

in vivo test. At the time of testing in-vitro test were not available

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study following official guidelines, GLP compliant, performed on a similar substance

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Trisodium bis[3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]naphthalene-1-sulphonato(3-)]chromate(3-)

EC Number:

278-127-8

EC Name:

Trisodium bis[3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]naphthalene-1-sulphonato(3-)]chromate(3-)

Molecular formula:

C40H22CrN4O10S2.H.2Na

IUPAC Name:

Trisodium bis[(E)-3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]naphthalene-1-sulphonate]chromate(3-)

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

The substance is the trisodium form of the target substance (disodium form)

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS- Source: Interfauna UK Ltd Wyton, Huntingdon, England- Age at study initiation: adult- Weight at study initiation: the animals were weighed immediately before application of the test substance- Housing: the rabbits were individually housed in stainless steel cages with flat rod bases or plastica cages with perforated bases, under standardised conventional conditions.- Diet (e.g. ad libitum): Standard diet "Ssniff K4" approx. 100-120g per animal/day; once a day in the morning- Water (e.g. ad libitum): tap water ad libitum- Acclimation period: prior to use the animals were acclimated for approx. one week in the animal room-Identification of the animals: the rabbits were identified by individual ear marks (tattoos) and cage cardsENVIRONMENTAL CONDITIONS- Temperature (°C): 21+/-1.5°C- Humidity (%): 60-80%- Air changes (per hr):12-15 times per hour- Photoperiod (hrs dark / hrs light):from 6 am to 6 pm, 12 hours artifical illumination

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

other: the controlateral skin area not treated with test substance served as control

Amount / concentration applied:

500mg

Duration of treatment / exposure:

4h

Observation period:

1, 24, 48 and 72h, 7d, 14d

Number of animals:

3

Details on study design:

Approx. 24hours before the test fur was shaved from the dorso-lateral area of the trunk (6x6 cm) of each of the rabbits. Care was taken to avoid abrading the skin. Only animals with healty and intact skin were used. 500 mg of the pulverised test substance were moistened with deionised water and subsequently applied to a hypoallergenic Hansamed patch. A further patch was moistened with water. The patches prepared in this way were placed in the opposite dorso-lateral areas of the trunk of each animal and were held in place with semiocclusive dressing for the duration of the exposure period. After the exposure time the dressing was removed and the exposed skin areas were carefully washed with water withou altering the existing response or the integrity of the epidermis.SCORING SYSTEM: for each animal the Draize scores recorded at 24, 48 and 72 h were added up. The total was divided by 3 to give the irritation index. This index was separately calculated for erythema/eschar formation and for oedema formation.TOOL USED TO ASSESS SCORE:fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: average 24,48 and 72h

Score:

ca. 0

Max. score:

0

Results 2

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: average 24,48 and 72h

Score:

ca. 0

Max. score:

0

Results 3

Irritation parameter:

edema score

Basis:

animal #3

Time point:

other: average 24,48 and 72h

Score:

ca. 0

Max. score:

0

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

The substance was tested for skin irritation following OECD 404 and resulted not to have irritant potential to the skin.

Executive summary:

The irritant/corrosive potential of the test substance was studied on the skin of rabbit in accordance with the OECD Guideline 404 for Testing of Chemicals.

Evaluation of erythema was not possible in all three animals due to the intense colouration by the test substance. Neverthless no other inflammatory signs (oedema or eschar formation) became apparent within the obervation period of 7 days. Signs of toxicity were not observed. This evidence indicates no hazard potential to the skin and the test substance may therefore be regarded as "not irritating" to the skin