2-Naphthalenecarboxylic acid, 4-[2-[5-substituted-2-methoxyphenyl]diazenyl]-3-hydroxy-, calcium salt (2:1)

Skin irritation / corrosion

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 guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

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 or test system 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

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24, 48 & 72 h

Score:

0

Max. score:

4

Results 2

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	432^1			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