Bis{tris[4-(mono and dimethylamino)phenyl]methylium} 2-(bis{4-[ethyl(3-sulfonatobenzyl)amino]phenyl}methyliumyl)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.

Cross-reference

Reason / purpose for cross-reference:

reference to other study

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 (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Bis{tris[4-(mono and dimethylamino)phenyl]methylium} 2-(bis{4-[ethyl(3- sulfonatobenzyl)amino]phenyl}methyliumyl)benzenesulfonate

IUPAC Name:

Bis{tris[4-(mono and dimethylamino)phenyl]methylium} 2-(bis{4-[ethyl(3- sulfonatobenzyl)amino]phenyl}methyliumyl)benzenesulfonate

Constituent 2

Reference substance name:

Bis{tris[4-(mono and dimethylamino)phenyl]methylium} 2-(bis{4-[ethyl(3-sulfonatobenzyl)amino]phenyl}methyliumyl)benzenesulfonate

EC Number:

700-610-3

Molecular formula:

UVCB substance - not applicable

IUPAC Name:

Bis{tris[4-(mono and dimethylamino)phenyl]methylium} 2-(bis{4-[ethyl(3-sulfonatobenzyl)amino]phenyl}methyliumyl)benzenesulfonate

Details on test material:

- Name of test material : Sepisol Fast Blue 2BR.
- Physical state/ appearance: dark blue powder.
- Lot/batch No.: 335001
- Storage condition of test material: ambient temperature and in the dark and protected from 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 of 2.4 kg.
- Housing: singly housed in a suspended stainless steel cage.
- Diet: Granules, Energie H326 COFNA (37000 Tours, France).
- Acclimation period: 5 days at least.

(Housing according the directive 86/609/CEE).

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 hours

Observation period:

72 hours

Number of animals:

3 rabbits

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 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: with dry cotton
- 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: 5828

Time point:

other: 1h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 24h

Results 2

Irritation parameter:

edema score

Basis:

animal: 5828

Time point:

other: 72h

Score:

0

Results 3

Irritation parameter:

erythema score

Basis:

animal: 5835

Time point:

other: 1 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 24 h

Results 4

Irritation parameter:

edema score

Basis:

animal: 5835

Time point:

other: 72 h

Score:

0

Results 5

Irritation parameter:

erythema score

Basis:

animal: 5836

Time point:

other: 72 h

Score:

0

Results 6

Irritation parameter:

edema score

Basis:

animal: 5836

Time point:

other: 72 h

Score:

0

Any other information on results incl. tables

Irritant/corrosive response data:

Erythema:

Id of animals	Observation time period (after removal of the patch)
	1h	24h	48h	72h	Mean*
5828	1	0	0	0	0.0
5835	1	0	0	0	0.0
5836	0	0	0	0	0.0

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

Edema:

Id of animals	Observation time period (after removal of the patch)
	1h	24h	48h	72h	Mean*
5828	0	0	0	0	0.0
5835	0	0	0	0	0.0
5836	0	0	0	0	0.0

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

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) and the regulation 1272/2008, Sepisol Fast Blue 2BR is found to be non-irritant for the skin of the rabbit.

Executive summary:

The aim of the study was to assess qualitatively and quatitatively irritancy or corrosion and the delay of appearance after single skin application of 0.5 g of test element, under semi-occlusive dressing for 4 hours, in rabbits.

The skin reactions (erythema and oedema) were scored 1h and then 24, 48 and 72 hours after patch removal.

The Sepisol Fast Blue 2BR was unclassified among the chemicals irritating to skin, in accordance of the directive 67/548/EEC and its successive amendments and the regulation 1272/2008.