3-methoxy-N,N-dimethylpropionamide

Endpoint summary

Description of key information

Skin irritation (OECD404): not irritating

Eye irritation (OECD405): irritating

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Reference 1

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

21 November 2006 - 02 December 2006

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

24 April 2002

Deviations:

no

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Accredited supplier (not specified).
- Age at study initiation: twelve to twenty weeks old
- Weight at study initiation: 2.0 to 3.5 kg
- Housing: Animals were housed individually 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

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: Adjacent areas of the untreated skin of each animal served as controls.

Amount / concentration applied:

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

Duration of treatment / exposure:

First animal a single application for 3 minutes, 1 hour and 4 hours.
Two animals a single application for 4 hours.

Observation period:

14 days.

Number of animals:

3 males.

Details on study design:

STUDY DESIGN
One rabbit was initially treated. After considerationof the skin reactions produced in the first animal, two additional animals were treated.

TEST SITE
On the day before the test each rabbit was clipped free of fur from the dorsal/flank area using veterinary clippers. Only animals with a healthy intact epidermis by gross observation were selected for the study.

Three suitable sites were selected on the back of the rabbit. At each site a quantity of 0.5 mL of the test material was introduced under a 2.5 cm x 2.5 cm cotton gauze patch and placed in position on the shorn skin. Each patch was secured in position with a strip of surgical adhesive tape. To prevent the animal interfering with the patches, the trunk of the rabbit was wrapped in an elasticated corset and the animal was returned to its cage for the duration of the 1 and 4 hour exposure periods.

REMOVAL OF TEST SUBSTANCE
3 minutes, 1 hour and 4 hours after the application, the patch was removed and the skin cleaned of residual test substance by gentle swabbing with cotton wool soaked in distilled water.

After consideration of the skin reactions produced in the first animal, two additional animals were treated.
One patch was applied to the back of each rabbit, and was allowed to remain in contact with the skin for a period of four hours.

OBSERVATIONS
The skin reactions were assessed at approximately 1, 24, 48 and 72 hours after the removal of the dressings and test substance. The irritation scores and a description of all other (local) effects were recorded.

SCORING SYSTEM:
The irritation was assessed according to the numerical scoring system according to OECD 404.

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal #1, #2 and #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal #1, #2 and #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

No evidence of skin irritation was noted during the study.

Interpretation of results:

other: Not irritating.

Remarks:

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

Conclusions:

In a skin irritation study with three male rabbits, performed according to OECD 404 test guideline and GLP principles, no irritation was observed.

Executive summary:

3-methoxy-N,N-dimethylpropanamide was tested in a skin irritation study with three male rabbits, performed according to OECD 404 test guideline and GLP principles.

No evidence of skin irritation was noted during the study.

Based on the results, 3-methoxy-N,Ndimethylpropanamide does not have to be classified for skin irritation according to Regulation (EC) No. 1272/2008.

Reference 2

Endpoint:

skin irritation: in vitro / ex vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Reference 1

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

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

24 April 2002

Deviations:

no

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

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

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.

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

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

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

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

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

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

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

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.

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.

Reference 2

Endpoint:

eye irritation: in vitro / ex vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation:

3-methoxy-N,N-dimethylpropanamide was tested in a skin irritation study with three male rabbits, performed according to OECD 404 test guideline and GLP principles.

No evidence of skin irritation was noted during the study.

Eye irritation:

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.

Justification for classification or non-classification

Based on the results, 3-methoxy-N,N-dimethylpropanamide does not have to be classified for skin irritation and the substance shall be classified as irritating to eyes, category 2, and labelled with H319: Causes serious eye irritation according to Regulation (EC) No. 1272/2008.