Pentasodium 4-amino-6-[[5-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-2-sulphonatophenyl]azo]-3-[(2,5-disulphonatophenyl)azo]-5-hydroxynaphthalene-2,7-disulphonate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 13 October, 1992 to 16 October, 1992

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Principles of method if other than guideline:

Guidelines followed

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Pentasodium 4-amino-6-[[5-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-2-sulphonatophenyl]azo]-3-[(2,5-disulphonatophenyl)azo]-5-hydroxynaphthalene-2,7-disulphonate

EC Number:

269-505-3

EC Name:

Pentasodium 4-amino-6-[[5-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-2-sulphonatophenyl]azo]-3-[(2,5-disulphonatophenyl)azo]-5-hydroxynaphthalene-2,7-disulphonate

Cas Number:

68259-02-9

Molecular formula:

C25H19ClN10O16S5.5Na

IUPAC Name:

pentasodium 4-amino-6-({5-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-2-sulfonatophenyl}diazenyl)-3-[(2,5-disulfonatophenyl)diazenyl]-5-hydroxynaphthalene-2,7-disulfonate

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 ANIMALS
- Source: Broekman Institute, Someren, The Netherlands
- Age at study initiation: Animal #1: Approximately 13 weeks; Animal #2 and #3: Approximately 12 weeks
- Weight at study initiation: 2419 to 2664 g
- Housing: Individually in labelled cages with perforated floors and equipped with an automatic drinking system (ITl, Bergen, The Netherlands)
- Diet: Standard laboratory rabbit diet (LKK-20, pellet diameter 4 mm, Hope Farms, Woerden, The Netherlands) approximately 100 g/d, ad libitum
- Water: Tap-water diluted with decalcified water, ad libitum
- Acclimation period: At least five days

ENVIRONMENTAL CONDITIONS
- Temperature: 21 °C
- Humidity: 55 %
- Air changes: Air-conditioned with 15 air changes/h
- Photoperiod: 12 h artificial fluorescent light/12 h dark

IN-LIFE DATES: From October 13, 1992 to October 16, 1992

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

water

Controls:

other: the untreated flank of the same animal

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 500 mg

VEHICLE
- The test substance was moistened with distilled water, immediately before application, to ensure close contact to the animal's skin.

Duration of treatment / exposure:

4 h

Observation period:

Up to 72 h (The skin reactions were assessed at approximately 45 min, 24, 48 and 72 h after the removal of the dressings and test substance)

Number of animals:

Three male animals.

Details on study design:

TEST SITE
- Area of exposure: Approx. 10x15 cm²
- Type of wrap if used: The test substance was applied using a moistened Scotchpak-non-woven patch mounted on Micropore tape (3M, St. Paul, U.S.A.). The contralateral flank was similarly prepared (but without test substance and vehicle) to act as a procedural control. The dressing was wrapped around the abdomen and secured with an elastic bandage (Coban, 3M, St. Paul, U.S.A.).

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Removed at the end of the exposure period using a tissue moistened with tap water and subsequently a dry tissue.
- Time after start of exposure: 4 h

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: Scoring of erythema was difficult due to blue staining of the treated skin at all observations (i.e., 45 minutes, 24, 48 and 72 h)

Results 2

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 3

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: Scoring of erythema was difficult at 24 h due to blue staining of the treated skin by the test substance.

Results 4

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 5

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: Scoring of erythema was difficult at 24 h due to blue staining of the treated skin by the test substance.

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

The observed skin irritation consisted of very slight erythema in animal #2 1 h after exposure, which had resolved within 24 h. No skin irritation was observed in animal #1 and #3 during the study.
There was no evidence of a corrosive effect on the skin.

Other effects:

Colouration: Blue staining of the treated skin by the test substance was observed, which made scoring of erythema difficult at the first two observations.
Body weights: The body weights and body weight gain in the animals were normal. Variation in body weight gain may be considered the result of treatment procedures.
Toxic symptoms/mortality: No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test substance was considered to be a non-irritant to skin.

Executive summary:

A study was performed to assess the skin irritation potential of the test substance (of ca. 100 % purity) in New Zealand White rabbits according to OECD Guideline 404 and EU Method B.4 in compliance with GLP.

500 mg of test substance were applied to a clipped skin area of 10 x 15 cm² on one flank of each animal under a 2 x 3 cm² gauze pad. The pad was allowed to remain in contact with the skin for 4 h. Animals were scored for irritation reactions after 45 minutes, and 24, 48 and 72 h. They were monitored daily for viability, mortality and clinical signs. Body weights were recorded pre-test and at study termination.

Blue staining of the treated skin by the test substance was observed, which made scoring of erythema difficult at 45 minutes and 24 h in 2/3 animals and in 1/3 animal at all observations. The observed skin irritation consisted of very slight erythema in 1/3 animal 45 minutes after exposure, which had resolved within 24 h. No skin irritation was observed in remaining animals. No signs of body weight variability, toxicity or mortality were observed in any animal during the study period.

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