disodium 7-{[4-chloro-6-(dodecylamino)-1,3,5-triazin-2-yl]amino}-4-hydroxy-3-[{4-[(4-sulfonatophenyl)diazen-1-yl]phenyl}diazen-1-yl]naphthalene-2-sulfonate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation / corrosion, other

Remarks:

in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

from 2 to 10 December, 1993

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Test conducted according to internationally accepted guidelines.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

(1992)

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

(1992)

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OTS 798.4470 (Acute Dermal Irritation)

Version / remarks:

(1991)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Red GS 3848

IUPAC Name:

Red GS 3848

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Test animalsAge at study initiation: 14 weeksWeight at study initiation: 2.7 kg (males), 2.8 kg (females)Housing: individually in cagesDiet: ad libitumWater: ad libitumAcclimation period: 4 days under test conditions after health examination. Only animals without any visual signs of illness were used for the study.Environmental conditions:Temperature: 20 ± 3 °CHumidity: 40 - 70 %Air changes: 10 - 15 per hourPhotoperiod: 12 hours artificial fluorescent light

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

water

Controls:

no

Amount / concentration applied:

Amount applied: 0.5 g of test substance slightly moistened with bi-distilled water.

Duration of treatment / exposure:

4 hours.

Observation period:

72 hours after the removal of the dressing.

Number of animals:

1 male and 2 females.

Details on study design:

Test siteArea of exposure: 100 cm2Coverage: 6 cm2Type of wrap if used: patch of surgical gauzeRemoval of test substanceWashing: lukewarm-tap waterTime after start of exposure: 4 hoursScoring systemErythema and eschar formation:No erythema: 0 Very light erythema (barely perceptible): 1Well defined erythema: 2Moderate to severe erythema: 3Severe erythema (beet redness) to slight eschar formation (injuries in depth): 4Maximum possible score: 4Edema formationNo edema: 0Very slight edema (slightly perceptible): 1Slight edema (edges of area well-defined by definite raising): 2Moderate edema (raised approximately 1mm): 3Severe edema (raised more than 1 mm and extending beyond area of exposure): 4Maximum possible score: 4Maximum cumulative score: 8

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: 3/3

Time point:

other: 24, 48, 72 hours

Score:

< 2.3

Results 2

Irritation parameter:

edema score

Basis:

animal: 3/3

Time point:

other: 24, 48, 72 hours

Score:

< 2.3

Other effects:

Clinical signs and mortalityNo systemic symptoms were observed in the animals during exposure and observation period and no mortality occurred.ColorationIn the area of application pink staining of the treated skin by test article was observed during the whole observation period.Body weightsOne female lost weight during the acclimation period. The body weight gain of the other animals was not affected during the study.

Any other information on results incl. tables

animal	mean 24 - 72 hours
	erythema	edema
male	0.0	0.0
female 1	0.0	0.0
female 2	0.0	0.0

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information according to the CLP Regulation (EC 1272/2008) Criteria used for interpretation of results: EU

Conclusions:

According to the CLP Regulation (EC 1272/2008) the substance is considered as non-irritant to the skin of rabbits.

Executive summary:

Method

Study in 1 male and 2 female rabbits by topical application of 0.5 g onto 6 cm² intact dorsal skin. The scoring of skin reactions was performed 1, 24, 48 and 72 hours after removing the dressing.

Result

Local signs (mean values from 24 to 72 hours) consisted of grade 0.00 erythema and grade 0.00 edema.

In the area of application, pink staining of the treated skin by the test article was observed during the whole observation period.

However the staining had no influence on the evaluation of skin reactions. No corrosive effect occurred on the treated skin of any animal at each measuring interval.