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Diss Factsheets

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

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

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: 2879
Time point:
other: 72h
Score:
1.7
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal: 2879
Time point:
other: 72h
Score:
0
Irritation parameter:
erythema score
Basis:
animal: 2880
Time point:
other: 72 h
Score:
1.7
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal: 2880
Time point:
other: 72 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal: 2881
Time point:
other: 72 h
Score:
1.7
Max. score:
2
Reversibility:
fully reversible within: 7 days
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  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  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.