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

Eye irritation

Administrative data

Endpoint:

eye 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 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

Version April 24, 2002

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2400 (Acute Eye Irritation)

Version / remarks:

Version August 1998

Deviations:

no

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 405

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 / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues 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: 3.57 kg – 3.68 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

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated left eye

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.1 mL bulk volume (about 17 mg of the comminuted test substance)

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

Readings were performed approx. 1, 24, 48, and 72 h after application and weekly thereafter (max. up to day 28).

Number of animals or in vitro replicates:

2 female and 1 male rabbits

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: the treated eye of each animal was rinsed with 3 to 6 mL of hand warm tap water for 1 - 2 minutes using a syringe with a blunt probe.
- Time after start of exposure: about 24 hours after application of the test substance

SCORING SYSTEM: according to the OECD Guideline 405

TOOL USED TO ASSESS SCORE: hand-slit lamp

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

all tested animals

Time point:

24/48 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

all tested animals

Time point:

24/48 h

Score:

0

Max. score:

2

Results 3

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

all tested animals

Time point:

24/48 h

Score:

0

Max. score:

4

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48 h

Score:

0

Max. score:

3

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48 h

Score:

0.5

Max. score:

3

Reversibility:

fully reversible within: 48 h

Results 6

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48 h

Score:

0

Max. score:

3

Irritant / corrosive response data:

- Slight conjunctival redness (grade 1) was observed in all animals 1 hour after application and persisted in one animal up to the 24-hour reading.
- Slight discharge (grade 1) was noted in all animals only 1 hour after application.
- The ocular reactions were reversible in two animals within 24 hours and in one animal within 48 hours after application.

Other effects:

In addition injected scleral vessels in a circumscribed area or circular were noted in the animals during the observation period.

Any other information on results incl. tables

Table 1: Individual ocular observations (only values until reversibility shown)

Readingperiods	Animal	Cornea		Iris	Conjunctivae
		Opacity	Area involved		Redness	Chemosis	Discharge
After 1 hour	1	0	0	0	1	0	1
	2	0	0	0	1	0	1
	3	0	0	0	1	0	1
After 24 hours	1	0	0	0	0	0	0
	2	0	0	0	1	0	0
	3	0	0	0	0	0	0
After 48 hours	1	0	0	0	0	0	0
	2	0	0	0	0	0	0
	3	0	0	0	0	0	0

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met