Butanamide, 2-[2-(2-methoxy-5-nitrophenyl)diazenyl]-N-(2-methoxyphenyl)-3-oxo-

Skin irritation / corrosion

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:

guideline study

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)

Version / remarks:

Version April 24, 2002

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

Version / remarks:

Version August 1998

Test guideline 3

Qualifier:

according to guideline

Guideline:

other: Japan MAFF Testing Guideline of 12 Nousan No. 8147, November 24, 2000 as this is in line with the OECD Guideline 404

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

2-[(1E)-2-(2-methoxy-5-nitrophenyl)diazen-1-yl]-N-(2-methoxyphenyl)-3-oxobutanamide

EC Number:

617-143-5

Cas Number:

80675-49-6

Molecular formula:

C18H18N4O6

IUPAC Name:

2-[(1E)-2-(2-methoxy-5-nitrophenyl)diazen-1-yl]-N-(2-methoxyphenyl)-3-oxobutanamide

Test material form:

solid: particulate/powder

Details on test material:

- Identifier: CAS 80675-49-6
- Lot/batch No.: L-7015-20
- Yellow powder
- Storage conditions: Ambient temperature, no protection from light necessary

Specific details on test material used for the study:

- Identifier: CAS 80675-49-6
- Lot/batch No.: L-7015-20
- Analytical purity: 95%
- Yellow powder
- Storage conditions: Ambient temperature, no protection from light necessary

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: New Zealand white A 1077 INRA (SPF) rabbits from Centre Lago S. A., 01540 Vonnas, France.
- Age at study initiation: 5 – 6 months
- Weight at study initiation: 3.69 kg – 3.88 kg
- Housing: single housing in stainless steel wire mesh cages with grating, floor area 3000 cm²
- Diet: ~ 130 g/animal per day, Kliba-Labordiaet (Kaninchen & Meerschweinchenhaltung “GLP”), Provimi Kliba SA, Kaiseraugst, Basel, Switzerland.
- Water: ad libitum, tap water
- Acclimation period: at least 5 days before application

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

water

Remarks:

because of the natural moisture of the skin highly de-ioinized water was used for moistening, so that the test was carried out under conditions as physiological as possible.

Controls:

other: untreated skin sites of the same animal

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.5 g
- Concentration: the solid test substance was minimally moistened with a suitable amount of highly de-ioinized water to guarantee skin contact immediately before test-substance application.

VEHICLE
- Amount applied: the test patch (2.5 cm x 2.5 cm) was covered with an amount of minimally moistened solid preparation corresponding to a dose of 0.5 g of undiluted test substance.

Duration of treatment / exposure:

4 h

Observation period:

Immediately after removal of the patch, ~ 1, 24, 48, and 72 h after removal of the patch and then in weekly intervals, max. up to day 14.

Number of animals:

2 female and 1 male rabbits

Details on study design:

TEST SITE
- Area of exposure: flank; the test substance was applied in a single dose to the intact untreated skin
- % coverage: 2.5 cm x 2.5 cm
- Type of wrap if used: the test patch was secured in position with a semiocclusive dressing.

REMOVAL OF TEST SUBSTANCE
- Washing: the test substance was removed at the end of the exposure period with Lutrol®** and Lutrol® / water (1 : 1).
- Time after start of exposure: 4 hours

SCORING SYSTEM: according to the OECD Guideline

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

edema score

Basis:

mean

Remarks:

all tested animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 h

Results 3

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 h

Irritant / corrosive response data:

Slight erythema (grade 1) was observed in two animals immediately after removal of the patch and persisted up to the 24-hour reading, but was reversible in one animal within 24 hours or within 48 hours, respectively. Moderate erythema (grade 2) was noted in one animal immediately after removal of the patch and decreased to slight after 1 hour.

Other effects:

A slight yellow discoloration of the skin was observed in all animals immediately after removal, but was reversible in all animals after 72 hours.

Any other information on results incl. tables

Table 1: Individual erythema and edema scores

Readingperiod	Animal	Erythema	Edema
After 0 hour	1	1	0
	2	2	0
	3	1	0
After 1 hour	1	1	0
	2	1	0
	3	1	0
After 24 hours	1	1	0
	2	0	0
	3	1	0
After 48 hours	1	0	0
	2	0	0
	3	0	0
After 72 hours	1	0	0
	2	0	0
	3	0	0

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met