N-[3-(dimethylamino)propyl]methacrylamide

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Range-finding study, test procedure in accordance with national standard methods with acceptable restrictions.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1973

Report date:

1973

Materials and methods

Test guideline

Guideline:

other: Range-finding-study

Principles of method if other than guideline:

Range-finding-study

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

N-[3-(dimethylamino)propyl]methacrylamide

EC Number:

226-002-3

EC Name:

N-[3-(dimethylamino)propyl]methacrylamide

Cas Number:

5205-93-6

Molecular formula:

C9H18N2O

IUPAC Name:

N-[3-(dimethylamino)propyl]-2-methylacrylamide

Test material form:

liquid

Specific details on test material used for the study:

- Name of test material (as cited in study report): Dimethylaminopropyl Methacrylamide
- Molecular weight (if other than submission substance): 170.25 g/mol

Test animals

Species:

rabbit

Strain:

not specified

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: 2166 - 2322 grams
- Fasting period before study: no data
- Housing: no data
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data
- Acclimation period: no data


ENVIRONMENTAL CONDITIONS
- Temperature (°C): room temperature
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: clipped skin of trunk
- % coverage: no data
- Type of wrap if used: no data


REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
- Time after start of exposure: no data


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1.25, 2.5, 5.0, 10.0 ml/kg bw
- Concentration (if solution): undiluted
- Constant volume or concentration used: no

Doses:

1.25, 2.5, 5.0, 10.0 ml/kg

No. of animals per sex per dose:

5

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

2 355 mg/kg bw

Remarks on result:

other: LD50= 2.50 ml/kg (1.19 to 5.24 ml/kg, dermal, rabbit, original value) Density = 0.94 g/cm³

Effect levels 2

Sex:

male

Dose descriptor:

LD0

Effect level:

1 175 mg/kg bw

Remarks on result:

other: 0/5 animals died

Mortality:

Dosage (ml/kg) died
10.0 3/5 animals
5.0 3/5 animals
2.5 3/5 animals
1.25 0/5 animals

Clinical signs:

other: Signs of intoxication: sluggish

Gross pathology:

Lungs, livers, spleens and kidneys congested; livers mottled.

Any other information on results incl. tables

Skin irritation: erythema and spotty areas of edema and/or necrosis.

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Remarks:

Migrated information: no Category according REGULATION (EC) No 1272/2008

Conclusions:

Dimethylaminopropyl methacrylamide is not listed in annex VI of REGULATION (EC) No 1272/2008. It is of low toxicity and not classified in the
current EU system. Under UN/OECD GHS the substance is Cat. 5 for acute dermal toxicity.
Oral LD50 male rabbits = 2355 mg/kg bw
GHS interpretation of the results yield in no Category for Dimethylaminopropyl methacrylamide.

Executive summary:

In an acute dermal toxicity study (Range-finding test), groups of 5 male Albino rabbits (source: no data, age: no data, weight: 2166 to 2294 grams), were given a single dermal dose of undiluted Dimethylaminopropyl methacrylamide (purity: >=98%) at doses of 1.25, 2.5, 5.0 and 10.0 ml/kg bw.  Animals were then observed for 14 days.

 

Dermal LD₅₀Males = 2.50 (1.19 - 5.24 ml/kg bw) ml/kg bw (original value) equals 2355 mg/kg bw

 

Dimethylaminopropyl methacrylamide is of lowToxicity based on the dermal LD₅₀in male rabbits. The substance has no toxicity category according to REGULATION (EC) No 1272/2008 but according to OECD GHS criteria Dimethylaminopropyl methacrylamide has toxicity category V.

There were no treatment related clincal signs, necropsy findings or changes in body weight in surviving animals.

Dermal LDL0 Males = 1.25 ml/kg bw

Dermal LD₁₀₀Males = > 10.0 ml/kg bw

This acute dermal range-finding study is classified as acceptable. It does satisfy the requirements for an acute dermal study in the male rabbit.