2-Propenamide, N-(2,2-dimethoxyethyl)-

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2009-10-12 to 2010-01-11

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Well performed study according to OECD Technical Guidelines.

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 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

24 April 2002

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Certificate attached to the report

Test material

Test material information

Constituent 1

Reference substance name:

N-(2,2-dimethoxyethyl)prop-2-enamide

EC Number:

610-472-5

Cas Number:

49707-23-5

Molecular formula:

C7 H13 N1 O3

IUPAC Name:

N-(2,2-dimethoxyethyl)prop-2-enamide

Details on test material:

- Sponsor's identification: NAAADA
- Container: plastic flask (n=1)
- Quantity: 51.80g (container and contents)
- Batch no: 700090909
- Production date: 09 September 2009
- CAS No of the main ingredients: 2226-96-2
- Date received: 16 September 2009
- Form: liquid
- Colour: yellow
- Storage: +4°C +/-4°C
- Expiry date: 09 January 2010
- Purity: >96%
- The item was used as supplied

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

- Supplied by: Elevage de Gérome (Quartier Labaste, F-40260 Linxe)
- Acclimitsation period: 5 days
- Weight at beginning of test: 2.99 - 3.37kg
- Age at beginning of test: 14 weeks

- Each animal was kept in an individual box installed in conventional air conditioned animal husbanding
- Temperature: 17-23°C
- Relative humidity: 30-70%
- Air exchange rate was approximately 15 timer per hour
- Housing was illuminated by aritificial light in a 12hrs lighting / 12hrs darkness cycle

- Drinking water: tap-water from public distribution system, ad libitum
- Foodstuff: SDS-C15, ad libitum
- Microbial and chemical analyses of the water were carried out once every six months by the IPL, Santé, Environment Durables - Atlantique

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: The untreated eye served as control

Amount / concentration applied:

0.1mL of the test item was instilled into the conjuncitival sac of one eye

Duration of treatment / exposure:

1d

Observation period (in vivo):

1, 24, 48, 72 hrs following treatment

Number of animals or in vitro replicates:

Three (initially, a single animal was treated. After consideration of the ocular responses produced in the first treated animal at day one, two additional animals were treated)

Details on study design:

- 0.1mL of the test item was instilled into the conjunctival sac of one eye
- The other eye remained untreated serving as control
- Intially, a single animal was treated
- After consideration of the ocular responses produced in the first treated animal at day 1, two additional animals were treated

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

all animals

Time point:

24/48/72 h

Score:

0.1

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

other: See Table 1

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #1

Remarks:

mean value

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: See Table 1

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #2

Remarks:

mean value

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

other: See Table 1

Results 4

Irritation parameter:

cornea opacity score

Basis:

animal #3

Remarks:

mean value

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: See Table 1

Results 5

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

all animals

Time point:

24/48/72 h

Score:

0.4

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

other: See Table 1

Results 6

Irritation parameter:

conjunctivae score

Remarks:

i.e. redness

Basis:

animal #1

Remarks:

mean value

Time point:

24/48/72 h

Score:

0.3

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

other: See Table 1

Results 7

Irritation parameter:

conjunctivae score

Remarks:

i.e. redness

Basis:

animal #2

Remarks:

mean value

Time point:

24/48/72 h

Score:

0.7

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

other: See Table 1

Results 8

Irritation parameter:

conjunctivae score

Remarks:

i.e. redness

Basis:

animal #3

Remarks:

mean value

Time point:

24/48/72 h

Score:

0.3

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

other: See Table 1

Results 9

Irritation parameter:

iris score

Basis:

mean

Remarks:

all animals

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

other: See Table 1

Results 10

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Reversibility:

not specified

Remarks on result:

other: See Table 1

Results 11

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Reversibility:

not specified

Remarks on result:

other: See Table 1

Results 12

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Reversibility:

not specified

Remarks on result:

other: See Table 1

Results 13

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

all animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: See Table 1

Results 14

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Reversibility:

not specified

Remarks on result:

other: See Table 1

Results 15

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Reversibility:

not specified

Remarks on result:

other: See Table 1

Results 16

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Reversibility:

not specified

Remarks on result:

other: See Table 1

Any other information on results incl. tables

Scoring according to OECD 405

Table 1: Individual and mean scores of conjunctivae, iris and cornea

Animal n°	Time after treatment	CONJUNCTIVAE		IRIS	CORNEA
		CHEMOSIS (A)	REDNESS (C)	LESION (D)	OPACITY (E)
A9821	24 hours	0	1	0	0
	48 hours	0	0	0	0
	72 hours	0	0	0	0
TOTAL		0	1	0	0
Mean		0.0	0.3	0.0	0.0
A9824	24 hours	0	1	0	1
	48 hours	0	1	0	0
	72 hours	0	0	0	0
TOTAL		0	2	0	1
Mean		0.0	0.7	0.0	0.3
A9830	24 hours	0	1	0	0
	48 hours	0	0	0	0
	72 hours	0	0	0	0
TOTAL		0	1	0	0
Mean		0.0	0.3	0.0	0.0
CLASSIFICATION in accordance with 67/548/EEC		According to the calculated means, the item is not be classified.
CLASSIFICATION in accordance with 1272/2008/EC		According to the calculated means, the item iss not be classified.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

In accordance with the Globally Harmonized System (Regulation (EC) No 1272/2008), the test item is not to be classified. No signal word and hazard statement are required.

Executive summary:

The test item NAAADA was instilled as supplied, into the eye of 3 New Zealand rabbits at the dose of 0.1 mL. The experimental protocol was established on the basis of the official method as defined in the OECD Guideline 405 dated April 24^th, 2002 and the test method B.5 of the council regulation no 440/2008.

The ocular conjunctivae reactions observed during the study have been slight and totally reversible in the three animals: a slight redness, noted 1 hour after the test item instillation and totally reversible between day 2 and day 3, associated with a slight chemosis, only noted 1 hour after the test item instillation.

A slight corneal opacity was noted in one animal on day 1 and was totally reversible on day 2.

In conclusion the results obtained under these experimental conditions enable to conclude that the test item NAAADA is not to be classified according to the criteria for the classification, packaging and labelling of dangerous substances in compliance with the EEC Directive no 67/548, 2001/59 and 99/45. No symbol and warning label are required.

In accordance with the Globally Harmonized System (Regulation (EC) No 1272/2008), the test item is not to be classified. No signal word and hazard statement are required.