N-methyl-N-vinylacetamide

Endpoint summary

Description of key information

In an acute oral toxicity study in rats a LD50 value of 1760 mg/kg bw was obtained. No mortality occurred in an acute inhalation toxicity study when rats were exposed with the test item in concentrations of 4000 ppm (16207 mg/m³). The LD50 value determined was 1.41 mL/kg bw (corresponding to 1354 mg/kg bw) in an acute dermal toxicity study in rabbits.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Qualifier:

no guideline followed

Principles of method if other than guideline:

Female rats (10/dose) were fasted before dosing for 12 hours.
Animals were treated in concentrations of 800-5000 mg/kg bw/day via gavage.
Observation period was at least 48 hours.

GLP compliance:

no

Remarks:

study performed prior to implementation of GLP

Test type:

other: please refer to principles of method if other than guideline

Limit test:

no

Species:

rat

Strain:

other: SPF Wistar K

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS

- Weight at study initiation: 80-106 g
- Fasting period before study: 12 hours before administration
- Diet: Standard-ALTROMIN R
- Water: tap water

Route of administration:

oral: gavage

Vehicle:

water

Remarks:

10% aqueous solution

Doses:

800 mg/kg bw
1250 mg/kg bw
2000 mg/kg bw
3200 mg/kg bw
5000 mg/kg bw

No. of animals per sex per dose:

10 per dose (only females)

Details on study design:

- Duration of observation period following administration: 7 days

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

1 760 mg/kg bw

Based on:

test mat.

Mortality:

Death occured within 100 min - 48 hours:
1250 mg/kg bw: 1/10
2000 mg/kg bw: 8/10
3200 mg/kg bw: 10/10
5000 mg/kg bw: 10/10

Clinical signs:

Ataxia, lateral/prone position and hyporeflexia

Interpretation of results:

Category 4 based on GHS criteria

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

1 760 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Qualifier:

no guideline followed

Principles of method if other than guideline:

Five rats were exposed to an vapour-air mixture for 4h, 14 days observation period following administration.

GLP compliance:

no

Remarks:

study performed prior to implementation of GLP

Test type:

other: Please refer to principles of method if other than guideline

Limit test:

yes

Species:

rat

Strain:

other: albino

Sex:

male

Details on test animals or test system and environmental conditions:

no data

Route of administration:

inhalation

Type of inhalation exposure:

not specified

Vehicle:

air

Details on inhalation exposure:

The vapour-air mixture is generated by passing 2.5 litres/minute of dried air at room temperature through a fritted glas disc immersed to a depth of at least one inch in approximately 50 mL if the test chemical contained in a gas-washing bottle.

Analytical verification of test atmosphere concentrations:

no

Duration of exposure:

4 h

Concentrations:

4000 ppm

No. of animals per sex per dose:

5

Details on study design:

- Duration of observation period following administration: 14 days

Key result

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 4 000 ppm

Based on:

test mat.

Remarks on result:

other: 4000 ppm corresponding to approximately 16207 mg/m³

Mortality:

0/5 animals died

Interpretation of results:

GHS criteria not met

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Value:

16 207 mg/m³

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Qualifier:

no guideline followed

Principles of method if other than guideline:

Four rabbits were exposed to the test item for 24 hours by an occlusive clip. The observation period was 14 days.

GLP compliance:

no

Remarks:

study performed prior to implementation of GLP

Test type:

other: Please refer to principles of method if other than guideline

Species:

rabbit

Strain:

other: New Zealand

Sex:

male

Details on test animals or test system and environmental conditions:

Weight: 2.5 to 3.5 kg

Type of coverage:

occlusive

Vehicle:

not specified

Details on dermal exposure:

- Fur is removed by clipping
- Dose is retained beneath an impervious plastic film
- The animals are immobilized during the 24-hour contact period

Duration of exposure:

24 hour followed by a 14-day observation period

Doses:

no data

No. of animals per sex per dose:

four

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

1.41 mL/kg bw

Based on:

test mat.

Remarks on result:

other: corresponding to 1354 mg/kg bw

Interpretation of results:

Category 4 based on GHS criteria

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

1 354 mg/kg bw

Additional information

Acute oral toxicity

Key study

A study (Hoechst AG, 1968) was performed to assess the acute oral toxicity of the test substance to the rat. A group of ten rats (females) was given a single dose by oral gavage of the test substance, formulated in 1 % aqueous solution, at a dose level of 800, 1250, 2000,3200 and 5000 mg/kg bw. After administration a 7 day observation period followed. One animal at 1250 mg/kg group, eight animals at the 2000 mg/kg bw group and all animals at the 3200 and 5000 mg/kg bw group died within 100 min – 48 hours and three males and all females at 5000 mg/kg died during the study. Death was accompandied by ataxia, lateral/prone position and hyporeflexia. The LD50 value was determined at 1760 mg/kg bw.

Acute toxicity inhalation

Key study

In an inhalation toxicity study (Smyth, 1962) five male rats were administered with the vapour-air mixture of the test substance in a concentration of 4000 ppm for 4 hours. The vapour-air mixture is generated by passing 2.5 litres/minute of dried air at room temperature through a fritted glas disc immersed to a depth of at least one inch in approximately 50 mL if the test chemical contained in a gas-washing bottle. The treated animals were observed for fourteen days. The acute lethal dermal dose of the test substance was found to be greater than 4000 ppm (corresponding to approximately 16207 mg/m³).

Acute dermal toxicity

Key study

A study (Smyth, 1962) was performed to assess the acute dermal toxicity of the test substance to five rabbits. Fur was removed by clipping and the test item was retained beneath an impervious plastic film. Animals were immobilized during the 24-hour contact period. The LD50 value was determined to be 1.41 mL/kg bw (corresponding to 1354 mg/kg bw).

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. The acute oral LD50 was determined to be 1760 mg/kg bw. As a result the substance is considered to be classified for acute oral toxicity Category 4 (H302: harmful if swallowed) under Regulation (EC) No 1272/2008, as amended for the ninth time in Regulation (EU) No 2016/1179.

The acute dermal LD50 was determined to be 1354 mg/kg bw. As a result the substance is considered to be classified for acute dermal toxicity Category 4 (H312: harmful in contact with skin) under Regulation (EC) No 1272/2008, as amended for the ninth time in Regulation (EU) No 2016/1179.

No mortality was observed at 16207 mg/m^3. As a result the substance is not considered to be classified for acute inhalation toxicity under Regulation (EC) No 1272/2008, as amended for the ninth time in Regulation (EU) No 2016/1179.