Sepisol Fast Violet 2B

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

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:

2008

Report date:

2008

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:

Mono and bis and tris{tris[4-(mono and dimethylamino)phenyl]methylium} [12,21,30,32-tetrahydro-29H,31Hphthalocyanine- mono, bis and trisulfonato-k4N29,N30,N31,N32]cuprate.

IUPAC Name:

Mono and bis and tris{tris[4-(mono and dimethylamino)phenyl]methylium} [12,21,30,32-tetrahydro-29H,31Hphthalocyanine- mono, bis and trisulfonato-k4N29,N30,N31,N32]cuprate.

Details on test material:

- Name of test material : Sepisol Fast Violet 2B
- Physical state/ appearance: dark violet powder
- Lot/batch No.: 423393
- Storage condition of test material: ambient temperature and in the dark

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Elevage GRIMAUD (49450 Roussay, France)
- Weight at study initiation:more than 2kg the day before the study initiation
- Housing: individually housed in a stainless steel cage ( 60 cm x 45 cm x 32 cm)
- Diet: granules Starlap Unic Robe
- Acclimation period: 5 days at least before study initiation

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C +/- 3
- Humidity (%): RH 50% +/-
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12hrs/12hrs

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

other: Olive oil

Controls:

yes, concurrent vehicle

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5g on a gaze


VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 mL

Duration of treatment / exposure:

4 hours

Observation period:

8 days

Number of animals:

3 rabbits

Details on study design:

TEST SITE
- Area of exposure: the treatment region (the back) of each rabbit was carefully clipped free of fur over an area of at least 14 cm x 5 cm. The test item was placed on a gauze square of approximately 6 cm2.
- Type of wrap if used: gauze moistened with the smallest quantity of olive oil. This gauze square
was protected by a pad consisting of a semi-occlusive micro-porous and non-allergenic dressing and
held in place with a supple and aerated fastening system consisting of elastic, adhesive, hypoallergenic
tape.


REMOVAL OF TEST SUBSTANCE
- Washing: with acetone
- Time after start of exposure: four 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: 2879

Time point:

other: 72h

Score:

1.7

Max. score:

2

Reversibility:

fully reversible within: 7 days

Results 2

Irritation parameter:

edema score

Basis:

animal: 2879

Time point:

other: 72h

Score:

0

Results 3

Irritation parameter:

erythema score

Basis:

animal: 2880

Time point:

other: 72 h

Score:

1.7

Max. score:

2

Reversibility:

fully reversible within: 7 days

Results 4

Irritation parameter:

edema score

Basis:

animal: 2880

Time point:

other: 72 h

Score:

0

Results 5

Irritation parameter:

erythema score

Basis:

animal: 2881

Time point:

other: 72 h

Score:

1.7

Max. score:

2

Reversibility:

fully reversible within: 7 days

Results 6

Irritation parameter:

edema score

Basis:

animal: 2881

Time point:

other: 72 h

Score:

0

Irritant / corrosive response data:

The test element is unclassified among the chemicals irritating to skin

Any other information on results incl. tables

Body weights following-up was normal.

Irritant/corrosive response data:

Animals with test material:

Edema:

Id of animals	Observation time period (after removal of the patch)
	1h	24h	48h	72h	Mean	D5	D6	D7	D8	D9	D10	D11	D12	D13	D14
2879	0	0	0	0	0	0	0	0	0	-	-	-	-	-	-
2880	0	0	0	0	0	0	0	0	0	-	-	-	-	-
2881	0	0	0	0	0	0	0	0	-	-	-	-	-	-	-

Erythema:

Id of animals	Observation time period (after removal of the patch)
	1h	24h	48h	72h	Mean	D5	D6	D7	D8	D9	D10	D11	D12	D13	D14
2879	1	2	2	1	1.7	1	1	0	-	-	-	-	-	-	-
2880	1	2	2	1	1.7	1	1	0	-	-	-	-	-	-
2881	1	2	2	1	1.7	1	1	0	-	-	-	-	-	-	-

CONTROLS: olive oil and cleaning with acetone

Edema:

Id of animals	Observation time period (after removal of the patch)
	1h	24h	48h	72h	Mean	D5	D6	D7	D8	D9	D10	D11	D12	D13	D14
2879	0	0	0	0	0	-	-	-	-	-	-	-	-	-	-
2880	0	0	0	0	0	-	-	-	-	-	-	-	-	-
2881	0	0	0	0	0	-	-	-	-	-	-	-	-	-	-

Erythema:

Id of animals	Observation time period (after removal of the patch)
	1h	24h	48h	72h	Mean	D5	D6	D7	D8	D9	D10	D11	D12	D13	D14
2879	0	1	0	0	0.3	-	-	-	-	-	-	-	-	-	-
2880	0	1	0	0	0.3	-	-	-	-	-	-	-	-	-
2881	0	1	0	0	0.3	-	-	-	-	-	-	-	-	-	-

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, Sepisol Fast Violet 2B was found to be non-irritant for the skin of the rabbit.