1,7-Naphthalenedisulfonic acid, 2-[[4-chloro-6-(cyanoamino)-1,3,5-triazin-2-yl]amino]-5-hydroxy-6-[2-[2-methoxy-5-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]diazenyl]-, lithium sodium salt (1:?:?)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From Jul. 06, 1999 to Oct. 14, 1999

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

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:

-

EC Number:

440-050-4

EC Name:

-

Cas Number:

243857-97-8

Molecular formula:

Hill formula: C23H(19-x-y)ClLixN8NayO14S4 (x+y=3), x and y > 0

IUPAC Name:

lithium(1+) disodium 2-{[4-chloro-6-(cyanoamino)-1,3,5-triazin-2-yl]amino}-5-hydroxy-6-(2-{2-methoxy-5-[2-(sulfonatooxy)ethanesulfonyl]phenyl}diazen-1-yl)naphthalene-1,7-disulfonate

Test material form:

solid: particulate/powder

Details on test material:

- Name of test material (as cited in study report): Reaktiv Orange DYPR 1466

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, 88353 Kiβlegg
- Weight at study initiation: 2.2 - 2.6 kg
- Diet: ssniff K-H (V2333), ad libitum and hay (approx. 15 g daily)
- Water: water from automatic water dispensers, ad libitum
- Acclimation period: 1 wk

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3 °C
- Humidity (%): 50±20 °C
- Photoperiod (hrs dark / hrs light): 12 h dark/12 h light

IN-LIFE DATES: From: Jul. 06, 1999 To: Jul. 13, 1999

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

water

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 g of test substance pasted with 0.5 mL deion. water

Duration of treatment / exposure:

4 h

Observation period:

24, 48 and 72 h after removal of the patches, additional readings were performed after 7 d

Number of animals:

Three

Details on study design:

TEST SITE
- Area of exposure: Dorsal region of the body
- % coverage: 25 cm2
- Type of wrap if used: Yes, The test substance was evenly distributed over the whole surface of a 2.5 x 2.5 cm cellulose patch on a piece of surgical plaster. The plaster was fixed to the prepared skin area and then covered with a semi-occlusive bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes, with warm water
- Time after start of exposure: 4 h

SCORING SYSTEM: Erythema, eschar formation and edema were evaluated numerically according to the score of DRAIZE

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema 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:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

No abnormalities detected in any of the tested animals at time points till 72 h

Other effects:

No signs of irritations were observed during the whole observation period
30 - 60 min up to 72 h after decontamination the skin of two animals showed an orange discoloration. 7 d after decontamination all discoloration were disappeared.

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 conducted to assess the skin irritation potential of test substance to the rabbit skin according to EU Method B.4. and OECD Guideline 404 in compliance with GLP.

Three animals were treated with 0.5 g of the test substance pasted with 0.5 mL deionised water using semi-occlusive patches for 4 h. After the exposure period all remnants of the test substance were carefully removed from the skin with warm tap water. The skin was evaluated for erythema, eschar formation and edema numerically according to the score of Draize system for up to 72 h after patch removal and additionally for 7 d.

No signs of irritation were observed during the whole observation period.30 - 60 min up to 72 h after decontamination the skin of two animals showed an orange discolouration and this discolouration disappeared 7 d after decontamination.

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