N-[3-(dimethylamino)propyl]methacrylamide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

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 test

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

Test animals

Species:

rat

Strain:

Wistar

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: 90 to 120 gram.
- Fasting period before study: nonfasted
- 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

Route of administration:

oral: unspecified

Vehicle:

other: undiluted

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 5.0 ml/kg bw

Doses:

1.25, 2.5 and 5.0 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

Results and discussion

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

3 334 mg/kg bw

Remarks on result:

other: LD50= 3.54 ml/kg (2.57 to 4.87 ml/kg, oral, rat, original value) Density = 0.94 g/cm³

Effect levels 2

Sex:

male

Dose descriptor:

LD100

Effect level:

4 700 mg/kg bw

Remarks on result:

other: 5/5 animals died within 2 days

Effect levels 3

Sex:

male

Dose descriptor:

LD0

Effect level:

2 350 mg/kg bw

Remarks on result:

other: 0/5 animals died

Mortality:

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

Clinical signs:

other: Signs of intoxication at 5.0 ml/kg: sluggish, pilo-erection, heavy breathing - 10 min.

Gross pathology:

Dead animals: congestion in the lungs, livers, spleens and kidneys mottled,; kidneys congested; adrenals slightly congested; stomachs distended,
liquid and gas filled pylorus hemorrhaged; intestines distended, gas filled, slightly yellow.
Survivors: no abnormal findings

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 oral toxicity.
Oral LD50 Males = 3334 mg/kg bw
GHS interpretation of the results yield in no Category for Dimethylaminopropyl methacrylamide.

Executive summary:

In an acute oral toxicity study (Range-finding test), groups of 5 male Harlan-Wistar Albino rats (source: no data, age: no data, weight: 90 to 120 gram), were given a single oral dose of undiluted Dimethylaminopropyl methacrylamide (purity: >=98%) at doses of 1.25, 2.5 and 5.0 ml/kg bw.  Animals were then observed for 14 days.

 

Oral LD₅₀ Males = 3.54 (2.57 - 4.87 ml/kg bw) ml/kg bw (original value) equals 3334 mg/kg bw

 

Dimethylaminopropyl methacrylamide is of low Toxicity based on the oral LD₅₀ in male rats. 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.

Oral LDL0 Males = 2.5 ml/kg bw

Oral LD₁₀₀ Males = 5.0 ml/kg bw

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

(NOTE: Any of the data in this dataset are disseminated by the European Union on a right-to-know basis and this is not a publication in the sense of a book or an article in a journal. The right of ownership in any part of this information is reserved by the data owner(s). The use of this information for any other, e.g. commercial purpose is strictly reserved to the data owners and those persons or legal entities, who have paid the respective access fee for the intended purpose.)