trisodium 3-amino-4-[4-[4-(2-(2-ethenylsulfonylethoxy)ethylamino)-6-fluoro-1,3,5-triazine-2-ylamino]-2-sulfophenylazo]-5-hydroxynaphthalene-2,7-disulfonate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Experiment start date - 30 March 1999; Experiment end date - 15 April 15 1999; Study completion date - 18 May 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:

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

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

429-240-8

EC Name:

-

Cas Number:

212652-59-0

Molecular formula:

Hill formula: C25 H22 F N8 Na3 O13 S4 CAS formula: C25 H25 F N8 O13 S4 · 3 Na

IUPAC Name:

trisodium 3-amino-4-[2-(4-{[4-({2-[2-(ethenesulfonyl)ethoxy]ethyl}amino)-6-fluoro-1,3,5-triazin-2-yl]amino}-2-sulfonatophenyl)diazen-1-yl]-5-hydroxynaphthalene-2,7-disulfonate

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): FAT 40575/B
- Physical state: Solid
- Analytical purity: Approx 75%
- Lot/batch No.: WP 23/99

Specific details on test material used for the study:

Identity: FAT 40'574/B
Batch: WP 23/99
Purity: Approx 75%
Appearance: Solid, dark-red powder
Storage: At room temperature at about 20 °C
Expiration Date: 08 February 2006

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Age when treated: Females: 14 weeks; Males: 16 weeks
Identification: By unique cage number and corresponding ear number.
Acclimatization: Under laboratory conditions, after health examination. Only animals without any visible signs of illness were used for the study.
Conditions: Standard Laboratory Conditions. Air-conditioned with 10-15 air changes per hour, with target ranges for room temperature 22 ± 3°C and relative humidity 40-70% (values above 70% during cleaning process possible).
Room environment was monitored continuously with hourly recordings. The room was illuminated by fluorescent light on a 12 hour light/dark cycle. Recorded music was played for approximately 8 hours during the light period.
Accommodation: Individually in stainless steel cages equipped with feed hoppers, drinking water bowls, with wood and haysticks for gnawing.
Diet: Pelleted standard Provimi Kliba 3418 rabbit maintenance diet ad libitum
Water: Community tap water from Itingen, available ad libitum.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

other: The test substance was moistened with bidistilled water

Controls:

yes, concurrent no treatment

Amount / concentration applied:

500 mg

Duration of treatment / exposure:

4 h

Observation period:

1, 24, 48 and 72 hours

Number of animals:

3

Details on study design:

Grading of Skin Reactions
ERYTHEMA AND ESCHAR FORMATION
No erythema................................................................................................................................ 0
Very slight erythema..................................................................................................................... 1
Well-defined erythema................................................................................................................... 2
Moderate to severe erythema......................................................................................................... 3
Severe erythema (beet redness) or eschar formation (injuries in depth preventing erythema reading...... 4

EDEMA FORMATION
No edema..................................................................................................................................... 0
Very slight edema (barely perceptible).............................................................................................. 1
Slight edema (edges of area well-defined by definite raising)............................................................... 2
Moderate edema (edges raised approximately 1 mm)......................................................................... 3
Severe edema (raised more than 1 mm and extending beyond the area of exposure)............................. 4

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

3 animals

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

Remarks:

3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

Application of the test article to healthy intact rabbit skin resulted in a primary irritation score of 0.00
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.

Other effects:

COLORATION: Violet staining by the test article of the treated skin area was observed until study termination.

MORTALITY/CLINICAL SIGNS: No clinical signs of systemic toxicity were observed in the animals during the test and observation period, and no mortality occurred.

CORROSION: No irreversible alterations of the treated skin were observed nor were corrosive effects evident on the skin.

BODY WEIGHTS: The body weight of all rabbits were considered to be within the normal range of variability.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

FAT 40574/B is not a skin irritant.

Executive summary:

The primary skin irritation potential of the test article was investigated by topical application of 0.5 g to 6 sq.cm intact dorsal skin of each of three young adult New Zealand White rabbits. This study was conducted according to OECD test guideline 404 in a GLP certified laboratory.

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 mean 24/48/72h erythema and edema scores was 0.00. 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 violet staining of the treated skin until the end of the observation period.

No corrosive effects were noted on the treated skin of any animal at any measuring interval.

Based upon the referred classification criteria (EEC Commission Directive 93/21/EEC of April 27, 1993), the test article is considered to be "not irritating" to rabbit skin.