Disodium 1-amino-4-[[3-[(5-chloro-2,6-difluoro-4-pyrimidinyl)amino]-2-methyl-5-sulphonatophenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Dec 1981

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

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:

Disodium 1-amino-4-[[3-[(5-chloro-2,6-difluoro-4-pyrimidinyl)amino]-2-methyl-5-sulphonatophenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate

EC Number:

276-374-6

EC Name:

Disodium 1-amino-4-[[3-[(5-chloro-2,6-difluoro-4-pyrimidinyl)amino]-2-methyl-5-sulphonatophenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate

Cas Number:

72139-17-4

Molecular formula:

C25H16ClF2N5O8S2.2Na

IUPAC Name:

disodium 1-amino-4-({3-[(5-chloro-2,6-difluoropyrimidin-4-yl)amino]-2-methyl-5-sulfophenyl}amino)-9,10-dioxo-9,10-dihydroanthracene-2-sulfonate

Test material form:

solid: particulate/powder

Details on test material:

Reactive Blue 114

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Lippischen Versuchstierzucht, Hagemann GmbH & Co. KG, 4923 Extertal 1, Germany
- Weight at study initiation: 2.6 kg (mean)
- Housing: one animal per cage
- Diet (e.g. ad libitum): ad libitum ("mümmel z" (ssniff / Soest))
- Water (e.g. ad libitum): ad libitum (tap water)
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 - 18
- Humidity (%): 40
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

water

Remarks:

test item was moistened

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg moistened with water

Duration of treatment / exposure:

4 hours

Observation period:

8 days, irritation scores were recorded 1, 24, 48 and 72 hours and 8 days after removal of test substance

Number of animals:

3 male rabbits

Details on study design:

TEST SITE
- Area of exposure: 6.25 cm ² (2.5 x 2.5 cm)
- Type of wrap if used: sterile compress (2.5 x 2.5 cm) fixed with patches (Leukoflex), covered with a surrounding of a thin sheet of gauze and afterwards the whole trunk wrapped with an elastique bandage (Eloflex)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with water or olive oil
- Time after start of exposure: 4 h

OBSERVATION TIME POINTS (indicate if minutes, hours or days)
- 1, 24, 48, 72 h and 8 days after removal of the test item

SCORING SYSTEM:
- Method of calculation: Draize (see Table 1 in box "Any other information on material and methods incl. tables")

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Remarks:

24 h value missing due to blue staining of skin, no indication irritation or corrosivity found

Irritant / corrosive response data:

No signs of irritation were observed. The erythema score of the 1 and 24 h time points could not be determined due to blue staining of the skin. For individual results please refer to Table 2 in box "Any other information on results incl. tables".

Any other information on results incl. tables

Table 2: Individual irritation scores

Animal Nr.	Draize Score
	1 h		24 h		48 h		72 h		Mean (24/48/72 h)		8 days
	Erythema	Edema	Erythema	Edema	Erythema	Edema	Erythema	Edema	Erythema	Edema	Erythema	Edema
1	x	0	x	0	0	0	0	0	0	0	0	0
2	x	0	x	0	0	0	0	0	0	0	0	0
3	x	0	x	0	0	0	0	0	0	0	0	0

x= scoring not possible due to blue staining of the skin

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In this acute dermal irritation/corrosion study, conducted according to OECD 404, the test item can be considered as non-irritating to the skin.

Executive summary:

In a primary dermal irritation study (OECD 404), three male New Zealand White rabbits were dermally exposed to 0.5 g of the test item for 4 hours to an area of exposure of 2.5 x 2.5 cm under semi-occlusive conditions. Animals then were observed for 8 days. Irritation was scored by the method of Draize. No signs of irritation have been recorded at any of the observation points (1, 24, 48 and 72 h and 8 days). Based on the results, the test item can be considered as no dermal irritant.