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Administrative data

Description of key information

N-[3-Dimethylamino)propyl]methacrylamide is of low acute toxicity in tests by oral or dermal administration (LD50: > 2000 mg/kg,

(Mellon Institute, Chemical Hygiene Fellowship (CHF), 1973) or by inhalation. The data requirements with regard to REACH legislation, annex VII – X, are fulfilled.

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:
other: Range-finding study, test procedure in accordance with national standard methods with acceptable restrictions.
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
Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals 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
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
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
Sex:
male
Dose descriptor:
LD100
Effect level:
4 700 mg/kg bw
Remarks on result:
other: 5/5 animals died within 2 days
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:
Signs of intoxication at 5.0 ml/kg: sluggish, pilo-erection, heavy breathing - 10 min.
Body weight:
Dosage (ml/kg) mean body weight (g)
I T
5.0 101 -
2.5 96 186
1.25 98 196
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
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.)

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
3 334 mg/kg bw
Quality of whole database:
There is one relevant, adequate and reliable (Klimisch score = 2) study for N-[3-(dimethylamino)propyl]methacrylamide available (Mellon Institute, Chemical Hygiene Fellowship (CHF), 1973). The test was performed in accordance with generally accepted scientific standards and described in
sufficient detail. Guideline study with acceptable restrictions. GLP (no data).

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:
other: Range-finding study, test procedure in accordance with national standard methods with acceptable restrictions.
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
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
Species:
rabbit
Strain:
not specified
Sex:
male
Details on test animals 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
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
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
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:
Signs of intoxication: sluggish
Body weight:
Dosage (ml/kg) mean body weight (g)
I T
10.0 2259 2320
5.0 2322 2704
2.5 2166 2196
1.25 2294 2562
Gross pathology:
Lungs, livers, spleens and kidneys congested; livers mottled.

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

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. 

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 355 mg/kg bw
Quality of whole database:
There is one relevant, adequate and reliable (Klimisch score = 2) study for N-[3-(dimethylamino)propyl]methacrylamide available (Mellon Institute, Chemical Hygiene Fellowship (CHF), 1973). The test was performed in accordance with generally accepted scientific standards and described in
sufficient detail. Guideline study with acceptable restrictions. GLP (no data).

Additional information

N-[3 -(Dimethylamino)propyl]methacrylamide is of low acute oral and dermal toxicity. LD50: 3334 mg/kg bw (oral rat, standard acute method) is higher than 2000 mg/kg bw in rats. In a recent acute standard study (Range-finding test), the dermal LD50 of DMAPMA was found to be higher than 2000 mg/kg bw in rabbits.


Justification for selection of acute toxicity – oral endpoint
Test was performed in accordance with generally accepted scientific standards and described in sufficient detail. Guideline study with acceptable restrictions.

Justification for selection of acute toxicity – dermal endpoint
Test was performed in accordance with generally accepted scientific standards and described in sufficient detail. Guideline study with acceptable restrictions.

Justification for classification or non-classification

Based on the results of the available studies, N-[3 -(dimethylamino)propyl)methacrylamide is not required to be classified for its acute toxicity potential according to 67/548/EEC and CLP/EU-GHS (1272/2008/EC).

Under UN-GHS (2009) requirements, DMAPMA has to be classified in cat. 5 in order to indicate that it may be harmful if swallowed or after contact with skin.