sodium 5-(4-amino-6-(4-((E)-4-(4-(bis(2-hydroxyethyl)amino)-6-(8-hydroxy-7-((E)-phenyldiazenyl)-3,6-disulfonatonaphthalen-1-ylamino)-1,3,5-triazin-2-ylamino)-2-sulfonatostyryl)-3-sulfonatophenylamino)-1,3,5-triazin-2-ylamino)-4-hydroxy-3-((E)-phenyldiazenyl)naphthalene-2,7-disulfonate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

other: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

1991-01-04 and 1991-08-08

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

The test was conducted by means of Read Across approach. Further information was attached at section 13

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

1987

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

1984

Deviations:

no

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Direct Red 227:1 – Similar Substance 01

IUPAC Name:

Direct Red 227:1 – Similar Substance 01

Test material form:

not specified

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd., Wölferstraße 4, CH-4414 Füllinsdorf
- Age at study initiation: males: 14 weeks, females: 15 weeks
- Weight at study initiation: males: 2.9 kg, female 3.1 kg
- Housing: individually in stainless steel cages (size: 35.5 x 55.5 x 45 cm) equipped with an automatic cleaning and drinking system
- Diet: Pelleted standard Kliba 341, Batch 61/91 rabbit maintenance diet ("Kliba", Klingentalmuehle AG, CH-4303 Kaiseraugst), ad libitum
- Water: Water Community tap water from Itingen, ad libitum
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 40 - 70
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

water

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.5 g

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

2 males
1 female

Details on study design:

TEST SITE
- Area of exposure: 6 cm2
- Type of wrap: It was covered with a 3.0 cm x 3.0 cm patch of surgical gauze. The gauze was covered with a semi-occlusive dressing. The dressing was wrapped around the abdomen and anchored with an elastic bandage.

REMOVAL OF TEST SUBSTANCE
- Washing: the skin was flushed with lukewarm tap water
- Time after start of exposure: 4 hours

SCORING SYSTEM: according to the OECD scoring system

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 24 h/48 h/ 72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: 24 h/ 48 h / 72 h

Score:

0

Max. score:

4

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: 24 h/ 48 h/ 72 h

Score:

0

Max. score:

4

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: 24 h/ 48 h/ 72 h

Score:

0

Max. score:

4

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: 24 h/48 h/ 72 h

Score:

0

Max. score:

4

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

other: 24 h/ 48 h/ 72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

No acute clinical symptoms were observed in the animals during the test and observation period, and no mortality occurred. In the area of application a red staining of the treated skin by pigment or coloring of the test article was observed. No destructions or irreversible alterations of the treated skin were observed. No corrosive effect was evident on the skin. The body weight gain of all rabbits was similar.

Applicant's summary and conclusion

Interpretation of results:

other: CLP criteria not met

Conclusions:

Not skin irritant

Executive summary:

The study was performed according to OECD guideline 404 and EU Method B.4, in three New Zealand White rabbits (2 males, 1 female.

Therefore, 0.5 g of the test substance (60% act. ingr.) was applied to approx. 6 square cm of the intact skin of the clipped area and covered in a semi-occlusive manner for 4 hours. The skin reaction was assessed at 1, 24, 48 and 72 hours after the removal of the test substance. Local signs (mean values from 24, 48, 72 hours) consisted of grade 0.0 erythema and grade 0.0 edema. No acute clinical symptoms were observed in the animals during the test and observation period, and no mortality occurred. In the area of application a red staining of the treated skin by pigment or coloring of the test article was observed.