Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
8 June 2010 - 26 June 2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material : J-37
- Substance type: red powder
- Physical state: powder
- Analytical purity: 99.3%
- Lot/batch No.: 91116
- Expiration date of the lot/batch: 16th April 2011
- Storage condition of test material: at room temperature in the dark in desiccators
- Stability under test conditions: stable

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan, Belton, Leics, England.
- Age at study initiation: 6 weeks old
- Weight at study initiation: at least 1.0 kg
- Housing: animals were indvidually housed in labeled cages with perforated floors (Ebeco, Germany, dimensions 67 x 62x 55 cm) and shelters (Ebeco, Germany, dimensions 40 x 32x 23 cm).
- Diet : pelleted diet for rabbits (Global Diet 2030 from Harlan Teklad, Mucedola, Milanese, Italy) approximately 100 grams per day. Hay (TecniLab- BMI BV, Someren, The Netherlands) was provided at least three times a week.
- Water : free access to tap water.
- Acclimation period: at least 5 days before start of treatment under laboratory conditions.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.0 ± 3.0 (Actual range: 19.0 - 23.4)
- Humidity (%): 40-70 (Actual range: 38-81)
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 hours artifical fluorescent light and 12 hours darkness per day.

IN-LIFE DATES: From: 8th June 2010 To: 26th June 2010

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

VEHICLE
- Amount(s) applied (volume or weight with unit): the test substance was moistened with 1 mL of the vehicle (water).
Duration of treatment / exposure:
4 hours
Observation period:
The skin reactions were assessed at approximately 1, 24, 48 and 72 hours after the removal of the dressing.
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2 x 3 cm
- Type of wrap if used: the patch was mounted on Micropore tape, which was wrapped around the abdomen and secured with Coban elastic bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the dressing was removed and the skin cleaned of residual test substance using tap water and watery ethanol (50% v/v) and watery acetone (50% v/v).
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48 & 72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24,48 & 72 h
Score:
0
Max. score:
4

Any other information on results incl. tables

No skin irritation was observed by 4 hours exposure to the test substance.

Red staining of the treated skin by the test substance was observed throughout the observation period which hampered the scoring of erythema on Day 1. No test substance remnants were seen.

No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.

Table 1. Individual skin irritation scores

Animal

4321

437

439

Time after exposure

Erythema (0-4)

Oedema (0-4)

Comments

Erythema (0-4)

Oedema (0-4)

Comments

Erythema (0-4)

Oedema (0-4)

Comments

1 Hour

-

0

a

-

0

a

-

 

a

24 Hour

0

0

a

0

0

a

0

0

a

48 Hour

0

0

a

0

0

a

0

0

a

72 Hour

0

0

a

0

0

a

0

0

a

 1Sentinel

Comments: - : No scoring possible due to red staining of the skin by the test substance

                    a : Red staining of the skin by the test substance.

Table 2. Mean values irritation scores.

Animal

Mean 24, 48 and 72 hrs

 

Erythema

Oedema

432

0.0

0.0

437

0.0

0.0

439

0.0

0.0

 

Table 3. Animal specifications

Animal

Sex

Age at start

(weeks)

Body weight (grams)

Prior to application

At termination

432

M

11

2210

2310

437

M

7-9

1596

1703

439

M

7-9

1798

1875

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU