reaction mass of: trisodium 3-(5-(2,6-difluoropyrimidin-4-ylamino)-2-sulfonatophenylazo)-5-(4-fluoro-6-morpholin-4-yl-1,3,5-triazin-2-ylamino)-4-hydroxy-2,7-naphthalenedisulfonate; trisodium 3-(5-(4,6-difluoropyrimidin-2-ylamino)-2-sulfonatophenylazo)-5-(4-fluoro-6-morpholin-4-yl-1,3,5-triazin-2-ylamino)-4-hydroxy-2,7-naphthalenedisulfonate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1998-03-24 to 1998-03-27

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:

436-890-6

EC Name:

-

Molecular formula:

C27H18F3N10Na3O11S3

IUPAC Name:

hexasodium 3-(2-{5-[(2,6-difluoropyrimidin-4-yl)amino]-2-sulfophenyl}diazen-1-yl)-5-{[4-fluoro-6-(morpholin-4-yl)-1,3,5-triazin-2-yl]amino}-4-hydroxynaphthalene-2,7-disulfonate 3-(2-{5-[(4,6-difluoropyrimidin-2-yl)amino]-2-sulfophenyl}diazen-1-yl)-5-{[4-fluoro-6-(morpholin-4-yl)-1,3,5-triazin-2-yl]amino}-4-hydroxynaphthalene-2,7-disulfonate

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: Charles River Deutschland GmbH
- Weight at study initiation: 3.6- 3.9 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: 2.5 x 2.5 cm
- 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:

mean

Remarks:

all animals

Time point:

24/48/72 h

Score:

0.1

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Remarks on result:

no indication of irritation

Results 2

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:

Reversibility of any observed effect: Changes fully reversible within 2 days

Other effects:

30-60 min up to 24 h after removing the plaster the treated skin of the animals showed very slight erythema. After removing the plaster all signs of skin irritations were reversible.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the result of this study Reactive Red FC73270 is not irritating to skin.

Executive summary:

In a primary dermal irritation study, 3 New Zealand albino rabbits obtained from Charles River Deutschland GmbH weighing 3.6 -3.9 kg were dermally exposed to Reactive Red FC73270 in deionized water to an area of 2.5 x 2.5 cm 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.

In this study, Reactive Red FC73270 is not irritating to the skin. A mean score of 0.1 for erythema does not warrant classification according to Regulation 1272/2008 (CLP)