6,13-dichloro-3,10-bis-{2-[4-fluoro-6-(2-sulfo-phenylamino)-1,3,5-triazin-2-ylamino]-propylamino}-benzo[5,6][1,4]oxazino[2,3-.b.]phenoxazine-4,11-disulphonic acid, lithium, sodium salt.

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

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:

6,13-dichloro-3,10-bis-{2-[4-fluoro-6-(2-sulfo-phenylamino)-1,3,5-triazin-2-ylamino]-propylamino}-benzo[5,6][1,4]oxazino[2,3-.b.]phenoxazine-4,11-disulphonic acid, lithium, sodium salt.

EC Number:

418-000-8

EC Name:

6,13-dichloro-3,10-bis-{2-[4-fluoro-6-(2-sulfo-phenylamino)-1,3,5-triazin-2-ylamino]-propylamino}-benzo[5,6][1,4]oxazino[2,3-.b.]phenoxazine-4,11-disulphonic acid, lithium, sodium salt.

Cas Number:

163062-28-0

Molecular formula:

CAS formula: C42 H34 Cl2F2 N14 O14 S4 .xLi. xNa

IUPAC Name:

dilithium(1+) disodium 6,13-dichloro-3,10-bis({[2-({4-fluoro-6-[(2-sulfonatophenyl)amino]-1,3,5-triazin-2-yl}amino)propyl]amino})-5,12-dioxa-7,14-diazapentacene-4,11-disulfonate

Details on test material:

- Name of test material (as cited in study report): FAT 40529/A
- Lot/batch No.: P 1/95
- Storage: Ambient conditions

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Pampaloni s.d.f., Via Pontita 16, 56043 Fauglia, Pisa, Italy
- Age at study initiation: 9 - 11 weeks
- Weight at study initiation: approximately 2 kg
- Housing: Individually in stainless steel cages measuring 63 x 48 x 41 cm and equipped with grid floors. Cages were suspended over trays and each tray held an absorbent material which was inspected daily and changed as necessary.
- Diet (e.g. ad libitum): Commercially available anti-biotic free pelleted laboratory diet (Altromin MSK, A. Rieper, Bolzano, Italy), ad libitum
- Water (e.g. ad libitum): Drinking water supplied to each cage via water bottles, ad libitum
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15-21
- Humidity (%): 45-65
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

no

Amount / concentration applied:

0.5g

Duration of treatment / exposure:

4 hours

Observation period:

up to 7 days

Number of animals:

3

Details on study design:

On the day of dosing a 0.5 g aliquot of the test substance was mixed to a paste with 2.5 mL of sterile water. This was spread evenly over a 2.5 x 2.5 cm. square of gauze. The gauze was placed on to the animal's skin, with the test substance in contact with the skin. This was covered by a strip of aluminium foil which was held in contact with the skin by encircling the trunk of the animal with an elastic adhesive bandage. All three rabbits of the group were treated in this manner. After four hours the bandages were removed and the treated sites gently cleaned using an absorbent material soaked in warm water.
One hour after removal of the patches and test substance the treated sites were assessed for signs of reaction to treatment. Similar examination was undertaken twenty four, forty eight and seventy two hours and seven days after the end of the four hour dosing period.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 1, 24, 48, 72 hours and 7 days

Score:

0

Max. score:

4

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 1, 24, 48, 72 hours and 7 days

Score:

0

Max. score:

4

Other effects:

Blue staining of the skin.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test substance has no observable irritant effect on the skin.

Executive summary:

In a GLP compliant skin irritation study, performed according to OECD guideline 404, the test substance (moistened, 0.5g) was applied to the skin of three New Zealand White rabbits for 4 hours. After 4 hours, the treated skin was flushed with water and observation were made for an additional 7 days. The test substance showed a erythema and edema grade of 0 at all observed time points. Under the conditions of this experiment, the test substance was found to be not irritating.