reaction mass of: tetrasodium 4-amino-6-(5-(2,6-difluoropyrimidin-4-ylamino)-2-sulfonatophenylazo)-5-hydroxy-3-(4-(sulfatoethylsulfonyl)phenylazo)naphthalene-2,7-disulfonate;tetrasodium 4-amino-6-(5-(4,6-difluoropyrimidin-2-ylamino)-2-sulfonatophenylazo)-5-hydroxy-3-(4-(2-sulfatoethylsulfonyl)phenylazo)naphthalene-2,7-disulfonate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1998

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1998

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:

-

EC Number:

431-830-5

EC Name:

-

Molecular formula:

C28H18F2N8Na4O16S5

IUPAC Name:

reaction mass of: tetrasodium 4-amino-6-(5-(2,6-difluoropyrimidin-4-ylamino)-2-sulfonatophenylazo)-5-hydroxy-3-(4-(sulfatoethylsulfonyl)phenylazo)naphthalene-2,7-disulfonate tetrasodium 4-amino-6-(5-(4,6-difluoropyrimidin-2-ylamino)-2-sulfonatophenylazo)-5-hydroxy-3-(4-(2-sulfatoethylsulfonyl)phenylazo)naphthalene-2,7-disulfonate

Test material form:

solid: particulate/powder

Details on test material:

- Name of test material (as cited in study report): Reaktiv Marineblau FC 63805

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland GmbH
- Weight at study initiation: 2.3- 2.8 kg
- Housing: in fully air-conditioned rooms in separate cages arranged in a battery
- Diet (e.g. ad libitum): ssniff K-H (V2333), ad libitum and hay (approx. 15 g daily)
- Water (e.g. ad libitum): water from automatic water dispensers, ad libitum
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3degrees C
- Humidity (%): 50± 20%
- Photoperiod (hrs dark / hrs light): 12 hours daily of light

Test system

Type of coverage:

semiocclusive

Preparation of test site:

abraded

Vehicle:

water

Controls:

no

Amount / concentration applied:

-500 mg test substance was applied with 0.45 mL deionized water

Duration of treatment / exposure:

4 h

Observation period:

30- 60 minutes, 24, 48 and 72 hours after removal of the patches

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 25 cm2
- Type of wrap if used: surgical plaster

REMOVAL OF TEST SUBSTANCE
- Washing (if done): substance were carefully removed from the skin with warm tap water
- Time after start of exposure: 4 h

SCORING SYSTEM:
- According to the score of DRAIZE

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: 1, 2

Time point:

24/48/72 h

Score:

0.7

Max. score:

4

Reversibility:

fully reversible within: 48 h

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Max. score:

4

Remarks on result:

not determinable

Remarks:

discolouration of skin did not allow a precise erythema analysis

Results 3

Irritation parameter:

edema score

Basis:

mean

Remarks:

(mean score 1)

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

No signs of corrosive effects

Other effects:

30-60 min up to 24 h after removing the plaster very slight to well shaped erythem and oedema were found in the animals. The skin surface was discoloured pale blue up to 48 h. 72 h after removing the plaster all signs of skin irritations were reversible.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Slight erythema effects occurred in 2/3 animals but were fully reversible within 48 h. The substance is not classifiable according to CLP criteria.

Executive summary:

In a primary dermal irritation study, 3 New Zealand albino rabbits obtained from Charles River Deutschland GmbH weighing 2.3-2.8 kg were dermally exposed to Reactive Navy FC63805 in deionized water to an area of 25 cm2 on the dorsal region of the body with hair removed with an electric clipper. Test sites were covered with a semi-occlusive dressing for 4 hours. Animals were then observed for 3 days. Irritation was scored according to DRAIZE.