N-methyl-N-vinylacetamide

Endpoint summary

Description of key information

No skin irritation was observed in rabbits. In an eye irritation study the test substance revealed an irritating potential in the rabbit eye. 

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1992-04-07 to 1992-04-17

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Well documented and reliable guideline study

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Specific details on test material used for the study:

- Lot/batch No.: HOE CG 0405 0A ZD00 0001
- Expiration date of the lot/batch: until November 1992

Species:

rabbit

Strain:

other: Chbb:NZW (SPF)

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Dr. Karl Thomae GmbH, 7950 Biberach, Germany
- Age at study initiation: 3-5 month
- Weight at study initiation: 3.0 - 3.3 kg
- Housing: individual housing
- Diet: Altromin 2123, ad libitum and hay (15 g/day)
- Water: deionisiesed, chlorinated water, ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/- 3°C
- Humidity (%): 55 +/- 20%
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.5 mL (treated area: 2.5 x 2.5 cm)

Duration of treatment / exposure:

4 hours

Observation period:

30-60 min and 24,48 and 72 h and 7 days after removal of the test item.

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: cellulose wrap

REMOVAL OF TEST SUBSTANCE
- Washing (if done): tepid water
- Time after start of exposure: after 4 hours

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.7

Max. score:

4

Reversibility:

fully reversible within: 3-7 days

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 3-7 days

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 3-7 days

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 3-7 days

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 3-7 days

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.7

Max. score:

4

Reversibility:

fully reversible within: 3-7 days

Interpretation of results:

GHS criteria not met

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1992-04-28 to 1992-05-26

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Well documented and reliable guideline study

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Specific details on test material used for the study:

- Lot/batch No.: HOE CG 0405 0A ZD00 0001
- Expiration date of the lot/batch: until November 1992

Species:

rabbit

Strain:

other: Chbb: NZW (SPF)

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Dr. Karl Thomas GmbH, 7960 Biberach
- Age at study initiation: 3-5 month
- Weight at study initiation: 3.1-3.5 kg
- Housing: individual housing
- Diet: Altromin 2123 ad libitum and hay (15 g/day)
- Water: deionisiesed, chlorinated water

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/- 3
- Humidity (%): 55 +/-20
- Photoperiod: 12 hours dark/12 hours light

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.1 mL

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

1,24, 48, 72 hours, 7 days and 14 days after instillation

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: physiological saline solution
- Time after start of exposure: 24 hours

TOOL USED TO ASSESS SCORE: fluorescein
Treated eye was examined with Fluorecein-sodium solution (0.01%) under UV light 24 hours before application and 24/72 hours after application.

Untreated eye served as control.

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

fully reversible within: 7-14 days

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 7-14 days

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 7-14 days

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 7-14 days

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 7-14 days

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 7-14 days

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #1

Time point:

24/48/72 h

Score:

2.7

Max. score:

3

Reversibility:

fully reversible within: 7-14 days

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #2

Time point:

24/48/72 h

Score:

2.7

Max. score:

3

Reversibility:

fully reversible within: 7-14 days

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #3

Time point:

24/48/72 h

Score:

2.7

Max. score:

3

Reversibility:

fully reversible within: 7-14 days

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

fully reversible within: 7-14 days

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2.3

Max. score:

4

Reversibility:

fully reversible within: 7-14 days

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 7-14 days

Other effects:

Alopecia surrounding treated eye, eye discharge mucous

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin

Key study

In a study (Hoechst AG, 1992) performed to assess the skin irritation potential of the test substance to rabbits three animals were administered a single dermal dose of 0.5 mL in a semi-occlusive application for 4 hours and observed for seven days. The skin of the rabbits revealed very slight edema scores (0, 0, 0.7) and slight erythema scores (0.7, 0.3, 2) by the mean of 24, 48, 72 h. The reactions had fully resolved by day 3-7. In conclusion, the test item is slightly irritating to the rabbit skin.

Eye

Key study

In an eye irritation study (Hoechst AG, 1992) three rabbits were administered a single ocular dose of 0.1 mL of the test substance for 24 hours and observed for 14 days after instillation. After the exposure time the eyes were washed with physiological saline solution whereby the untreated eye of each animal served as control. The treated eye was examined with Fluorecein-sodium solution (0.01%) under UV light 24 hours before application and 24/72 hours after application. The mean (24, 48, 72 h) cornea (3,2,2), iris (1,1,1), conjunctivae (2.7, 2.7, 2.7) and chemosis (3, 2.3, 2) scores for each animal showed mild to moderate eye irritating effects accompanied by alopecia surrounding treated eye and eye discharge mucous. All effects were fully reversible within 7-14 days. In conclusion, the test item is irritating to the rabbit eye.

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008

The available data are reliable and suitable for classification purposes under Regulation 1272/2008. Reversible eye irritation potential was determined. As a result the substance is considered to be classified as eye irritating Category 2 (H319: causes serious eye irritation) under Regulation (EC) No 1272/2008, as amended for the ninth time in Regulation (EU) No 2016/1179.

No skin irritation potential was determined. As a result the substance is not considered to be classified for skin irritation under Regulation (EC) No 1272/2008, as amended for the ninth time in Regulation (EU) No 2016/1179.