Reaction mass of lithium sodium hydrogen 4-amino-6-({5-[(5-chloro-2,6-difluoropyrimidin-4-yl)amino]-2-sulfonatophenyl}diazenyl)-5-hydroxy-3-[(4-{[2-(sulfonatooxy)ethyl]sulfonyl}phenyl)diazenyl]naphthalene-2,7-disulfonate and lithium sodium hydrogen 4-amino-6-({5-[(5-chloro-2,6-difluoropyrimidin-4-yl)amino]-2-sulfonatophenyl}diazenyl)-5-hydroxy-3-{[4-(vinylsulfonyl)phenyl]diazenyl}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:

1987

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Lithium sodium hydrogen 4-amino-6-(5-(5-chloro-2,6-difluoropyrimidin-4-ylamino)-2-sulfonatophenylazo)-5-hydroxy-3-(4-(2-(sulfonatooxy)ethylsulfonyl)phenylazo)naphthalene-2,7-disulfonate

EC Number:

401-560-2

EC Name:

Lithium sodium hydrogen 4-amino-6-(5-(5-chloro-2,6-difluoropyrimidin-4-ylamino)-2-sulfonatophenylazo)-5-hydroxy-3-(4-(2-(sulfonatooxy)ethylsulfonyl)phenylazo)naphthalene-2,7-disulfonate

Cas Number:

108624-00-6

Molecular formula:

C28H(21-x-y)ClF2Li(x)N8Na(y)O16S5

IUPAC Name:

Lithium sodium hydrogen-4-amino-6-(5-(5-chloro-2,6-difluoropyrimidine-4-ylamino)-2-sulfonatophenylazo)-5-hydroxy-3-(4-(2-(sulfonatooxy)ethylsulfonyl)phenylazo)naphthalene-2,7-disulfonate

Test material form:

solid: particulate/powder

Details on test material:

Reactive Blue FC 05717

Test animals

Species:

rabbit

Strain:

other: HC: NZW

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Interfauna UK Ltd
- Weight at study initiation: 3.4 - 3.6 kg
- Housing: individual mesh cages, Type III
- Diet (e.g. ad libitum): ssniff K4, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: 14 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22°C
- Humidity (%): 45-65%
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

yes, concurrent no treatment

Amount / concentration applied:

500 mg

Duration of treatment / exposure:

The duration of exposure was 4 h. The treated area was washed with water after end of exposure period.

Observation period:

24, 48 and 72 h after removal of the patches.

Number of animals:

3 females

Details on study design:

TEST PROCEDURE
About 24 h before the start of the study the hair in the contralateral sides of the dorsal region of the body of 3 rabbits was removed with an electric clipper over an area of about 6 cm2. Only animals with intact skin were used.

Each animal was treated with 0.5 g test substance in water. The substance was applied over the whole surface of a 6 x 6 cm patch on a piece of surgical plaster (i.e. specially produced by BeierSdorf Aktiengesellschaft). The plaster was fixed to the prepared skin area and then covered with a semi-occlusive bandage.

The exposure period was 4 h. After the exposure period all remnants of the test substance were carefully removed from the skin with water.

Examinations of the skin took place 24, 48 and 72 h after removal of the patches.

Erythema, eschar formation and edema were evaluated numerically according to the Draize scoring system. All other changes of the skin were recorded.

SCORING SYSTEM:

Erythema and eschar formation
No erythema........................................................................................................................0
Very slight erythema (barely perceptible) ......................................................................1
Well-defined erythema ......................................................................................................2
Moderate to severe erythema............................................................................................3
Severe erythema (beet redness) to eschar formation (injuries in depth) preventing
grading of erythema...........................................................................................................4

Edema - swelling
No edema..............................................................................................................................0
Very slight edema (barely perceptible).............................................................................1
Slight edema (edges of area well defined by definite raising).......................................2
Moderate edema (raised approximately 1 mm) ..............................................................3
Severe edema (raised more than 1 mm and extending beyond area of exposure)...4

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

(mean score)

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

(mean score)

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Remarks:

(mean score)

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

(mean score)

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Remarks:

(mean score)

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Remarks:

(mean score)

Time point:

24/48/72 h

Score:

0

Max. score:

4

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the test conditions, the test substance was considered to be non-irritating to rabbit skin.

Executive summary:

A study was performed to assess the skin irritation potential of the test substance in female New Zealand albino rabbits according to OECD Guideline 404, in compliance with GLP. 500 mg of the test substance pasted with water was evenly applied over the whole surface of a 6 x 6 cm cellulose patch on a piece of surgical plaster. The plaster was fixed to the prepared skin area of about 6 cm² and then covered with a semi-occlusive bandage. The patch was allowed to remain in contact with the skin for 4 h. After the exposure period, all remnants of the test substance were carefully removed with warm tap water. Animals were scored for irritation reactions after 24, 48 and 72 h. No signs of irritation were observed during the whole observation period. Overall mean scores for dermal irritation were calculated to be 0.0 for erythema and eschar formation and 0.0 for edema formation. Under the test conditions, the test substance was considered to be non-irritating to rabbit skin (Ruf, 1987a).