reaction mass of: pentasodium 4-amino-5-hydroxy-3-{(E)-4-[2-(sulfonatooxy)ethylsulfonyl]phenylazo}-6-{(E)-2-sulfonato-4-[2-(sulfonatooxy)ethylsulfonyl]phenylazo}naphthalene-2,7-disulfonate;tetrasodium 4-amino-5-hydroxy-3-{(E)-4-[2-(sulfonatooxy)ethylsulfonyl]phenylazo}-6-[(E)-2-sulfonato-4-(vinylsulfonyl)phenylazo]naphthalene-2,7-disulfonate;tetrasodium 4-amino-5-hydroxy-6-[(E)-2-sulfonato-4-[2-(sulfonatooxy)ethylsulfonyl]phenylazo}-3-[(E)-4-(vinylsulfonyl)phenylazo]naphthalene-2,7-disulfonate;trisodium 4-amino-5-hydroxy-3-[(2-hydroxyethylsulfonyl)-phenylazo]-6-[(E)-2-sulfonato-4-(vinylsulfonyl)phenylazo]naphthalene-2,7-disulfonate;trisodium 4-amino-5-hydroxy-3-[(E)-4-(vinylsulfonyl)phenylazo]-6-[(E)-2-sulfonato-4-(vinylsulfonyl)phenylazo]naphthalene-2,7-disulfonate;trisodium 4-amino-5-hydroxy-3-[(E)-4-(vinylsulfonyl)phenylazo]-6-[-2-sulfonato-4-(2-hydroxyethylsulfonyl)phenylazo]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:

From February 02 to February 11, 1999

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

The reliability of the source study is 1

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

July 17, 1992

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Similar Substance

IUPAC Name:

Similar Substance

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Elevage Scientifique des Dombes F-01400 Chatillon sur Chalaronne
- Age at study initiation: 15 weeks
- Housing: Individually in stainless steel cages with an automatic cleaning system equipped with feed hoppers, drinking water bowls, with wood and haysticks for gnawing
- Diet (e.g. ad libitum): Pelleted standa¡d Provirni Kliba 3418 rabbit maintenance diet ad libitum
- Water (e.g. ad libitum): Community tap water from Itingen, ad libitum, in water bowls
- Acclimation period: Under laboratory conditions after health examination. Only animals without any visual signs of illness were used for the study

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3 °C
- Humidity (%): 40 - 70 %
- Air changes (per hr): 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): fluorescent light on a 12 hour lighldark cycle

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

water

Remarks:

bidistilled water

Amount / concentration applied:

0.5 g test item per animal

Duration of treatment / exposure:

4 hours

Number of animals:

1 male and 2 females

Details on study design:

TEST SITE
- Area of exposure: 6 cm2 of the intact skin of the clipped area
- Type of wrap if used: the skin was covered with a 2.5 cm x 2.5 cm patch of surgical gauze and the gauze was covered with a semi-occlusive dressing. The dressing was wrapped around the
abdomen and anchored with tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the skin was flushed with lukewarm tap water
- Time after start of exposure: immediately after exposure

OBSERVATION TIME POINTS
Viability/mortality: Daily
Clinical signs: Daily during the observation period
Body weights: At start of acclimatization, on the first day of application and at termination of observation.

SCORING SYSTEM:
The skin reaction was assessed according to the numerical scoring system listed in the EEC
Commission Directive 92/69/EEC, July 31, 1992 at approximately 1, 24, 48 and 72 hours after the removal of the dressing, gauze patch and test aficle.
If evident, corrosive or staining properties of the test article were described and recorded.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

edema score

Basis:

animal: all

Time point:

24/48/72 h

Score:

0

Results 2

Irritation parameter:

erythema score

Basis:

animal: all

Time point:

24/48/72 h

Score:

0

Applicant's summary and conclusion

Interpretation of results:

other: CLP criteria not met

Conclusions:

Not skin irritant

Executive summary:

The primary skin irritation potential of the test article was investigated by topical application of 0.5 g to 6 cm2 intact dorsal skin of each of three young adult New Zealand White rabbits according to the OECD guideline 404.
The duration of treatment was four hours. The scoring of skin reactions was performed 1, 24, 48 and 72 hours after removal of the dressing. The scores of each animal at the following reading times (24, 48, 72 hours) were used in calculating the respective mean values for each type of lesion.
The primary irritation score was calculated by totalling the individual cumulative scores at 24, 48 and 72 hours and then dividing by the number of data points. The primary irritation score was 0.00 (max. 8.0).
Local signs (mean values from 24 to 72 hours) consisted of grade 0.00 erythema and grade 0.00 edema. No signs of irritation were observed.
The test article caused light blue staining of the treated skin.
No corrosive effects were noted on the treated skin of any animal at any measuring interval.