tetrakis[({bis[4-(dimethylamino)phenyl] and 4-(methylamino)phenyl} or {4-(dimethylamino)phenyl and bis[4-(methylamino)phenyl]} or {tris[4-(dimethylamino)phenyl]}methylium)]C12-(branched and/or linear)-alkyl-(4-sulfonatophenoxy)benzenesulfonate and oxybis[C12-(branched and/or linear)-alkyl-benzenesulfonate].

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 1997-01-06 to 1997-01-10

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

The reliability is rated 1 because the study followed the standard guideline of reference (OECD 404), which describes a procedure designed to evaluate this endpoint. The results were reviewed for reliability and assessed as valid, and the study was conducted under GLP condition.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1997

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

bis(bis[4-(dimethylamino)phenyl][4-(methylamino)phenyl]methylium) bis(tris[4-(dimethylamino)phenyl]methylium) 3-(dodecan-3-yl)-4-(2-dodecyl-4-sulfonatophenoxy)benzene-1-sulfonate 3-dodecyl-4-(4-sulfonatophenoxy)benzene-1-sulfonate

EC Number:

700-759-4

Molecular formula:

not applicable

IUPAC Name:

bis(bis[4-(dimethylamino)phenyl][4-(methylamino)phenyl]methylium) bis(tris[4-(dimethylamino)phenyl]methylium) 3-(dodecan-3-yl)-4-(2-dodecyl-4-sulfonatophenoxy)benzene-1-sulfonate 3-dodecyl-4-(4-sulfonatophenoxy)benzene-1-sulfonate

Details on test material:

- Name of test material (as cited in study report): Sepisol Fast Violet 88-1239
- Substance type: Organic salt - UVCB
- Physical state: dark violet powder with green flep colour
- Lot/batch No.: 412675
- Storage condition of test material: Room temperature, sheltered from light and heat

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Elevage BERTHO (22120 - Yffiniac, FRANCE).
- Weight at study initiation: mean weight = 2.56 kg.
- Housing: individually housed (according the directive CEE/86/609).
- Diet: granules Energy H326 (COFNA - 37000 - Tours, France).
- Acclimation period: 5 days at least before study initiation.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

water

Remarks:

distilled

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5g on shaved skin moistened with 0.25 ml of distilled water (Meram lot 43216)

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.25 mL

Duration of treatment / exposure:

4 hrs

Observation period:

72 hrs

Number of animals:

3 males

Details on study design:

TEST SITE
- Area of exposure: the fur of the treatment region (the dorsal area of the trunk) of each rabbit was carefully removed by shaving. The test item was applied on the shaved skin.
- Type of wrap if used: the area of exposure is covered by a 2.5 x 2.5 cm gauze. This gauze square is held in place with a "Micropore" tape of 5 x 5 cm. Then the trunk is covered by a stretchable band of 10 cm wide (type band varix) , fixed with a tape.

REMOVAL OF TEST SUBSTANCE
- Washing: dry wiping and then with a coton sightly wet with distilled water
- Time after start of exposure: 4 hours

SCORING SYSTEM: Grading of Skin Reactions displayed in the OECD 404 method

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: #1 and 2

Time point:

other: 1, 24 and 48 hrs

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 72 hrs

Results 2

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 72 hrs

Score:

0

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: 1 and 24 hrs

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 48 hrs

Results 4

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: 48 and 72 hrs

Score:

0

Results 5

Irritation parameter:

edema score

Basis:

animal: #1, 2 and 3

Time point:

other: 1, 24, 48 and 72 hrs

Score:

0

Max. score:

0

Any other information on results incl. tables

Erythema Score (intact skin)

Animal N°	1 hr	24 hrs	48 hrs	72 hrs	Mean*
5824	1°	1°	1°	0°	0.7
5826	1°	1°	1°	0°	0.7
5827	1°	1°	0°	0°	0.3

 * Mean score 24, 48 and 72 hrs after patch removal.

° purple coloration

Edema Score (intact skin)

Animal N°	1 hr	24 hrs	48 hrs	72 hrs	Mean*
5824	0	0	0	0	0
5826	0	0	0	0	0
5827	0	0	0	0	0

 * Mean score 24, 48 and 72 hrs after patch removal.

Body weights

Animal N°	24hrs before the beginning of the study	End of the study (72 hrs)
5824	2.660 kg	2.620 kg
5826	2.500 kg	2.540 kg
5827	2.520 kg	2.592 kg
MEAN	2.560 kg	2.584 kg

 

Clinical observations

Nothing to report

 

 

 

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the experimental conditions adopted, and according to the criteria defined in the directive 67/548/EEC (and its successive amendments) Sepisol Fast Violet 881239 was found to be non-irritant for the skin of the rabbit.

Executive summary:

The aim of the study was to assess qualitatively and quantitatively irritancy or corrosion and the delay of appearance after single skin

application of 0.5 g of test element (moistened with 25 mL of distilled water), under semi-occlusive dressing for 4 hours in 3 males rabbits. The experimental protocol was established according to the official method as defined in the OECD guideline No. 404 dated July 17th, 1992.

The skin reactions (erythema and edema) were scored at 1, 24, 48 and 72 hours after patch removal.

In all animals, a very slight erythema appeared at 1 and 24 hrs after patch removal, totally reversible with 48 to 72 hrs. No edema was recored in all aminals.

The Sepisol Fast violet 881239 was unclassified among the chemicals irritating to skin, in accordance with the directive 67/548/EEC and its successive amendments.