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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2008
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report Date:
2008

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
- Name of test material (as cited in study report): Sepisol fast Blue 85219
- Substance type: organic salt - UVCB
- Appearance/Physical state: dark blue powder
- Stability under test conditions: stable
- Storage condition of test material:room temperature
Specific details on test material used for the study:
- Batch N° 310551

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Elevage GRIMAUD (49450 Roussay, France)
- Age at study initiation:
- Weight at study initiation:more than 2kg the day before the study initiation
- Housing: individually housed in an "inox" cage ( 60 cm x 45 cm x 32 cm)
- Diet: granules Starlap Unic Robe
- Water (e.g. ad libitum):
- 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 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: 2876
Time point:
24/48/72 h
Score:
ca. 1.7
Max. score:
2
Reversibility:
fully reversible within: 8 days
Irritation parameter:
edema score
Basis:
animal: 2876
Time point:
24/48/72 h
Score:
ca. 0
Reversibility:
fully reversible within: 8 days
Irritation parameter:
erythema score
Basis:
animal: 2877
Time point:
24/48/72 h
Score:
ca. 2
Max. score:
2
Reversibility:
fully reversible within: 8 days
Irritation parameter:
edema score
Basis:
animal: 2877
Time point:
24/48/72 h
Score:
ca. 0
Reversibility:
fully reversible within: 8 days
Irritation parameter:
erythema score
Basis:
animal: 2878
Time point:
24/48/72 h
Score:
ca. 1.7
Max. score:
2
Reversibility:
fully reversible within: 8 days
Irritation parameter:
edema score
Basis:
animal: 2878
Time point:
24/48/72 h
Score:
ca. 0
Reversibility:
fully reversible within: 8 days
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:

Oedema:

    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
 2876  0  0  0  0  0  0  0  0  0  -  -  -  -  -  -
 2877  0  0  0  0  0  0  0  0  0  -  -  -  -  -
 2878 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
 2876  1  2  2  1  1.7  1  1  1  0  -  -  -  -  -  -
 2877  1  2  2  2  2  2  2  1  0  -  -  -  -  -
 2878  2  2  1  1.7  1  1  0  -  -  -  -  -  -  -

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the experimental conditions adopted, and according to the criteria defined in the directive 67/548/EEC, Sepisol Fast Blue 85219 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 0.5g of test element moistened with olive oil, under semi-occlusive dressing for 4 hours, in 3 rabbits.

The assay was performed according to the OECD guideline 404.

The skin reactions (erythema and oedema) were scored 1h and then 24, 48 and 72 hours after patch removal and until complete reversibility of the effects (D8).

The test element was classified in accordance with the criteria defined in the decree of 20/04/1994 taken in enforcement from the basic Directive 67/548/EEC of the Official Journal of European Communities of June 27, and its successive amendments.

The study was performed from 2008/03/17 to 2008/03/25.

The mean score 24h, 48h and 72h after application for oedema was 0 for all animals (3/3).

The mean score 24h, 48h and 72h after application for erythema was of 1.7 for 2/3 animals and of 2.0 for 1/3 animal.

The test element was unclassified among the chemicals irritating to skin.