N-alkylester N-aryl substituted aryl diazo aryl amine

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

03 to 06 Feb 2009

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Compliant to OECD 404 and GLP guideline

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Details on test material:

Name: DYNS 2246

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Species and strain: New Zealand White rabbit
- Source: Sándor Ferenc, 2173 Kartal, Császár út 135, HUNGARY
- Age at study initiation: 10 weeks
- Weight at study initiation: 3440 to 3493 g
- Housing: single
- Diet: PURINA Base – Lap gr. diet for rabbits ad libitum
- Water: tap water ad libitum
- Acclimation period: 20 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16.3-20.3°C
- Humidity (%): 20-41 %
- Air changes (per hr): 15-20
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 03 February 2009 to 06 February 2009

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

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

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 6 cm²
- Type of wrap if used: plastic wrap


REMOVAL OF TEST SUBSTANCE
- Washing (if done): body temperature water
- Time after start of exposure: 4 hours


SCORING SYSTEM:
Erythema and eschar formation
No erythema 0
Very slight erythema (barely perceptible) 1
Well defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth) 4

Oedema formation
No oedema 0
Very slight oedema (barely perceptible) 1
Slight oedema (edges of area well defined by definite raising) 2
Moderate oedema (raised approximately 1 mm) 3
Severe oedema (raised more than 1 mm and extending beyond area of exp.) 4

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: 1, 2, 3

Time point:

other: 1 hour

Score:

1

Max. score:

4

Reversibility:

fully reversible

Results 2

Irritation parameter:

erythema score

Basis:

animal: 1 and 2

Time point:

other: 24 hours

Score:

0

Max. score:

4

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: 24 hours

Score:

1

Max. score:

4

Reversibility:

fully reversible

Results 4

Irritation parameter:

erythema score

Basis:

animal: 1, 2, 3

Time point:

other: 48 and 72 hours

Score:

0

Max. score:

4

Results 5

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: 1 hour

Score:

1

Max. score:

4

Reversibility:

fully reversible

Results 6

Irritation parameter:

edema score

Basis:

animal: 1,2,3

Time point:

other: 24 to 72 hours

Score:

0

Max. score:

4

Any other information on results incl. tables

SCORING OF ERYTHEMA FORMATION

Animal No./ Sex	Body weight (g)		1 h	24 h	48 h	72 h	7 d	14 d
	at the beginning of the study	at the end of the study
7604/ M	3493	3594	1	0	0	0	-	-
7602/ M	3440	3491	1	0	0	0	-	-
7689/ M	3484	3545	1	1	0	0	-	-
TOTAL	-	-	3	1	0	0	-	-

SCORING OF OEDEMA FORMATION

Animal No./ Sex	Body weight (g)		1 h	24 h	48 h	72 h	7 d	14 d
	at the beginning of the study	at the end of the study
7604/ M	3493	3594	1	0	0	0	-	-
7602/ M	3440	3491	0	0	0	0	-	-
7689/ M	3484	3545	0	0	0	0	-	-
TOTAL	-	-	1	0	0	0	-	-

M = male; d = day; h = hour; - = no data

MEAN VALUES OF SKIN IRRITATION SCORES (24, 48, 72 hours reading)

Animal Number	Sex	Erythema	Oedema
7604	male	0.00	0.00
7602	male	0.00	0.00
7689	male	0.33	0.00

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

According to Regulation (EC) No 1272/2008, DYNS 2246 does not require classification as a skin irritant.
According to the UN Globally Harmonised System of Classification and Labelling of Chemicals, DYNS 2246 does not require classification as a skin irritant.

Executive summary:

An acute skin irritation study of the test item DYNS 2246 was performed in three New Zealand White rabbits. Parameters monitored during this study included mortality, body weight measurements and clinical observations. The irritation effects of the test item were evaluated according to the Draize method (OECD No.: 404, 2002).

The test item was administered undiluted, as a single dose of , to the hairless skin of all experimental rabbits with moistening by approximately 1 ml of water. The untreated skin of each animal served as control.

After 4 hours, the remaining test item was removed with water of body temperature.

To assess skin irritation, animals were examined at 1, 24, 48 and 72 hours after the patch removal. Additional general examinations were performed daily.

There was no mortality or systemic clinical changes related to DYNS 2246 administration.

There was no effect of treatment on body weight.

At observation one hour after patch removal, very slight erythema (score 1) was observed in all three animals and very slight oedema (score 1) was observed in one animal.

At 24 hours after patch removal, very slight erythema (score 1) was noted in one animal.

At 48 and 72 hours after patch removal, there were no signs observed on the skin of the treated animals.

As no clinical signs were observed up to 72 hours after patch removal, the study was terminated after the 72 hours observation.

The animals' individual mean scores (considering readings at 24, 48 and 72 hours after patch removal) for erythema were 0.00, 0.00 and 0.33 respectively.

The animals' individual mean scores (considering readings at 24, 48 and 72 hours after patch removal) for oedema were 0.00, 0.00 and 0.00 respectively.

According to Directive Regulation (EC) No 1272/2008, DYNS 2246 does not require classification as a skin irritant.

According to the UN Globally Harmonised System of Classification and Labelling of Chemicals, DYNS 2246 does not require classification as a skin irritant.