3-methoxy-N,N-dimethylpropionamide

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

05 December 2006 - 25 December 2006

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

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)

Test material

Test material information

Constituent 1

Reference substance name:

3-methoxy-N,N-dimethylpropionamide

EC Number:

258-420-7

EC Name:

3-methoxy-N,N-dimethylpropionamide

Cas Number:

53185-52-7

Molecular formula:

C6H13NO2

IUPAC Name:

3-methoxy-N,N-dimethylpropanamide

Test material form:

liquid

Details on test material:

- Appearance: Extremely pale yellow liquid
- Storage condition of test material: Approximately 4°C in the dark under nitrogen

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Accredited supplier (not specified).
- Age at study initiation: Animals were twelve to twenty weeks old.
- Weight at study initiation: Body weights were 2.0 to 3.5 kg.
- Housing: Individually housed in suspended cages.
- Diet: Free access to Certified Rabbit diet (not specified).
- Water: Free access to mains drinking water.
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS (set to maintain)
- Temperature (°C): 17 – 23
- Humidity (%): 30 - 70
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: One eye of each animal remained untreated and served as the reference control.

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.1 mL

Duration of treatment / exposure:

Single instillation on Day 1.

Observation period (in vivo):

The eyes of each animal were examined approximately 1, 24, 48 and 72 hours and 7 days after instillation of the test substance.

Number of animals or in vitro replicates:

3 males

Details on study design:

STUDY DESIGN
Initially, a single rabbit was treated. After consideration of the ocular responses produced in the first treated animal, two additional animals were treated.

TREATMENT
A volume of 0.1 mL of the test material was placed into the conjunctival sac of the right eye, formed by gently pulling the lower lid away from the eyeball. The upper and lower eyelids were held together for about one second immediately after treatment, to prevent loss of the test material, and then released. The left eye remained untreated and was used for control purposes. Immediately after administration of the test material, an assessment of the initial pain reaction was made.

REMOVAL OF TEST SUBSTANCE
-Washing (if done): No

OBSERVATIONS
- Irritation:
The eyes of each animal were examined approximately 1, 24, 48 and 72 hours and 7 days after instillation of the test substance.
The irritation scores and a description of all other (local) effects were recorded. The irritation was assessed according to OECD 405.
Examination of the eye was facilitated by the use of the light source from a standard ophthalmoscope.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Remarks:

(opacity)

Basis:

animal #1

Remarks:

(mean)

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 2

Irritation parameter:

cornea opacity score

Remarks:

(opacity)

Basis:

mean

Remarks:

animal #2 and #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

iris score

Basis:

animal #1

Remarks:

(mean)

Time point:

24/48/72 h

Score:

0.67

Max. score:

2

Reversibility:

fully reversible within: 72 hours

Results 4

Irritation parameter:

iris score

Basis:

mean

Remarks:

animal #2 and #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Results 5

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

mean

Remarks:

animal #1 and #3

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

fully reversible within: 7 days

Results 6

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #2

Remarks:

(mean)

Time point:

24/48/72 h

Score:

1.67

Max. score:

3

Reversibility:

fully reversible within: 7 days

Results 7

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

animal #1 and #2

Time point:

24/48/72 h

Score:

1.33

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 8

Irritation parameter:

chemosis score

Basis:

animal #3

Remarks:

(mean)

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Irritant / corrosive response data:

Scattered or diffuse corneal opacity was noted in one treated eye at the 24, 48 and 72-hour observations. Iridial inflammation was noted in one treated eye one hour after treatment and at the 24 and 48-hour observations.
Moderate conjunctival irritation was noted in all treated eyes one hour after treatment and at the 24 and 48-hour observations with minimal to moderate conjunctival irritation noted in all treated eyes at the 72-hour observation.
All treated eyes appeared normal at the 7-day observation.

Applicant's summary and conclusion

Interpretation of results:

other: Irritating.

Remarks:

According to Regulation (EC) No. 1272/2008.

Conclusions:

In an eye irritation study with male rabbits, performed according to OECD 405 test guideline and GLP principles, limited irritation was observed.

Executive summary:

3-methoxy-N,N-dimethylpropanamide was tested in an eye irritation study with three male rabbits, performed according to OECD 405 test guideline and GLP principles, irritation was observed.

Scattered or diffuse corneal opacity was noted in one treated eye at the 24, 48 and 72-hour observations. Iridial inflammation was noted in one treated eye one hour after treatment and at the 24 and 48-hour observations. Moderate conjunctival irritation was noted in all treated eyes one hour after treatment and at the 24 and 48-hour observations with minimal to moderate conjunctival irritation noted in all treated eyes at the 72-hour observation. All treated eyes appeared normal at the 7-day observation.

Based on the results, 3-methoxy-N,Ndimethylpropanamide shall be classified as irritating to eyes, category 2, and labelled with H319: Causes serious eye irritation according to Regulation (EC) No. 1272/2008.