Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 226-002-3 | CAS number: 5205-93-6
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Toxicological Summary
- Administrative data
- Workers - Hazard via inhalation route
- Workers - Hazard via dermal route
- Workers - Hazard for the eyes
- Additional information - workers
- General Population - Hazard via inhalation route
- General Population - Hazard via dermal route
- General Population - Hazard via oral route
- General Population - Hazard for the eyes
- Additional information - General Population
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 26.45 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 10
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 264.5 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Oral to inhalation route-to-route extrapolation (ECHA, 2008). Correction for rat standard breathing volume (ECHA R8
guidance p. 63, ECHA 2008) -Correction for activity driven differences of respiratory volumes in workers compared to workers in rest (10 m³/6.7 m³) is required (ECHA 2008).
- AF for dose response relationship:
- 1
- Justification:
- The NOAEC is reliable. No adjustment is required. (see also discussion below).
- AF for differences in duration of exposure:
- 2
- Justification:
- The NOAEC is based on a 13-week study. AF for extrapolation from sub-chronic to chronic (ECHA 2008).
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- No allometric scalling rat to humans as inhalation (ECHA 2008). 2.5 for remaining differences not justified (ECETOC, 2010) There is no good reason for an additional factor of 2.5. ECETOC has shown that, as a default mechanism, this is not justified. Taking differences in toxicokinetic into account a normal intraspecies factor is justified but beyond that there is no scientific basis for additional safety factors.
- AF for other interspecies differences:
- 1
- Justification:
- No other factor required, ubiquitous metabolic pathways, equally present in rodents and humans.
- AF for intraspecies differences:
- 5
- Justification:
- Default AF for Worker (ECHA R.8, 2012)
- AF for the quality of the whole database:
- 1
- Justification:
- The key study (being rated K1) as well as the database in general are comprehensive and high quality. No adjustment is required.
- AF for remaining uncertainties:
- 1
- Justification:
- No further adjustment necessary.
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 7.5 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 40
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 300 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- No adjustment is necessary (oral to dermal).
- AF for dose response relationship:
- 1
- Justification:
- The starting point is fully reliable. No adjustment required.
- AF for differences in duration of exposure:
- 2
- Justification:
- The NOAEL is based on a subchronic study, default AF.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Allometric scaling rat to humans AF 4 (ECHA 2008). 2.5 for remaining differences not justified (ECETOC, 2010), see comment below.
- AF for other interspecies differences:
- 1
- Justification:
- No other factor required, ubiquitous metabolic pathways, equally present in rodents and humans.
- AF for intraspecies differences:
- 5
- Justification:
- Default AF for Worker (ECHA R.8, 2012)
- AF for the quality of the whole database:
- 1
- Justification:
- The key study (being rated K1) as well as the database in general are comprehensive and of high quality. No adjustment is required.
- AF for remaining uncertainties:
- 1
- Justification:
- No further adjustment necessary.
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - workers
Acute, short-term exposure
Acute systemic effects
Since the acute toxicity of N-[3-Dimethylamino)propyl]methacrylamide is low and the vapour pressure is only 0.4 Pa at 20 °C an acutely toxic exposure is not expected.
Acute local effects
N-[3-Dimethylamino)propyl]methacrylamide is strongly irritating to the eyes and irritating and sensitising to skin. DNELs for eye irritation cannot be derived. Also for sensitisation, where all EC3 values in the LLNA are above 3, a DNEL cannot be derived. For both end points only a qualitative risk assessment is required.
The substance is a skin sensitiser, hence, use of dermal protection is indicated whenever a chance for direct dermal contact exists.
Long-term exposure (dermal) - systemic effects
In an OECD 422 Combined repeated dose toxicity study with reproduction/developmental toxicity by oral dosage up to 400 mg/kg bw/d absolute and relative increase in spleen weight were noted in females and a dose related increase of relative kidneys and liver weights in males. Also at 400 mg/kg bw unilateral, slight to moderate tubular atrophy was observed in the testes of 3/5 male animals. All these findings were not seen in a 90 d oral sub-chronic repeated dose toxicity study, OECD 408, where the animals were tested up to 300 mg/kg bw/d with no observed adverse effects. Under the results of the 90 day study the overall NOAEL male/female will be 300 mg/kg bw/d.
On the assumption, that in general, dermal absorption will not be higher than the absorption in the oral study no default factor (factor 1) should be used when performing oral to dermal exposure. Therefore no correction of the NOAEL oral for the dermal route will be necessary.
Calculation of the oral/dermal DNEL for DMAPMA - Workers
Description |
Value |
Remark |
Step 1) Relevant dose-descriptor |
NOAEL: |
NOAEL for rats in a subchronic study |
Step 2) Modification of starting point |
1 |
No adjustment is necessary (oral to dermal) |
Step 3) Assessment factors |
|
|
Interspecies |
4 |
Allometric scaling rat to humans AF 4 (ECHA 2008). 2.5 for remaining differences not justified (ECETOC, 2010), see comment below. |
Intraspecies |
5 |
Default AF for Worker (ECHA R.8, 2012) |
Exposure duration |
2 |
The NOAEL is based on a subchronic study, default AF |
Dose response |
1 |
The NOAEL is reliable. No adjustment is required. |
Quality of database |
1 |
The key study (being rated K1) as well as the database in general are comprehensive and of high quality. No adjustment is required. |
DNEL |
Value |
|
based on NOAELratof |
Using a total factor (Allometric scaling and AF) of 40 ( 4 x 5 x 2 x 1) a DNELlong-term,workerof 7.5 mg/kg bw/d is derived. |
Long-term exposure (inhalation) - systemic effects
Based on POD modifiers for route-to-route extrapolation, rat breathing volume and slight exercise, the corrected NOAECinhalbased on a systemic NOAEL of 300 mg/kg bw/d by oral route is 264.5 mg/m³ for inhalation.
Calculation of the inhalation DNEL for DMAPMA- Workers
Description |
Value |
Remark |
|
Step 1) Relevant dose-descriptor |
300 mg/kg bw/d |
NOAEL in a subchronic study in rats |
|
Step 2) Modification of starting point |
2
0.38 m³/kg bw
10 m3/6.7 m3 |
Oral to inhalation route-to-route extrapolation (ECHA, 2008) Correction for rat standard breathing volume (ECHA R8 guidance p. 63, ECHA 2008) -Correction for activity driven differences of respiratory volumes in workers compared to workers in rest (10 m3/6.7 m3) is required (ECHA 2008). |
|
Modified starting point |
264.5 mg/m³ |
|
|
Step 3) Assessment factors |
1 |
No allometric scaling rat to humans as intraspecies adjustment is accounted for in relative breathing volumes. 2.5 for remaining differences not justified (ECETOC, 2010). |
|
Interspecies |
1 |
No allometric scaling rat to humans as inhalation (ECHA 2008). 2.5 for remaining differences not justified (ECETOC, 2010, in press) * |
|
Intraspecies |
5 |
Default AF for Worker (ECHA R.8, 2012) |
|
Exposure duration |
2 |
The NOAEC is based on a 13-week study. AF for extrapolation from Sub-chronic to chronic (ECHA 2008). |
|
Dose response |
1 |
The NOAEC is reliable. No adjustment is required. (see also discussion below) |
|
Quality of database |
1 |
The key study (being rated K1) as well as the database in general are comprehensive and of high quality. No adjustment is required. |
|
DNEL |
Value |
||
Based on NOAEL of 300 mg/kg bw in a subchronic study in rats |
Using a POD modifier of 1.13 (2 x 0.38 x 10/6.7) and an AF of 10 (5 x 2) a DNELlong-term,workerof 26.45 mg/m3is derived. |
* There is no good reason for an additional factor of 2.5. ECETOC has shown that, as a default mechanism, this is not justified. Taking differences in toxicokinetics into account a normal intraspecies factor is justified but beyond that there is no scientific basis for additional safety factors.
Long-term exposure (dermal) - local effects
As indicated in the acute section, the substance is a skin sensitiser, hence, use of dermal protection is indicated whenever a chance for direct dermal contact exists.
ECHA, 2008/2012, Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health
ECETOC, 2010 Guidance on Assessment Factors to Derive a DNEL, Technical Report No. 110, ISSN-0773-8072-110.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 6.5 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 20
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 130.4 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Oral to inhalation route-to-route extrapolation (ECHA, 2008). Correction for rat standard breathing volume vs. humans,
24 h exposure (ECHA R8 guidance p. 63, ECHA 2008) -No correction for activity driven differences of respiratory volumes required for general population (ECHA 2008).
- AF for dose response relationship:
- 1
- Justification:
- The NOAEC is reliable. No adjustment is required. (see also discussion below).
- AF for differences in duration of exposure:
- 2
- Justification:
- The NOAEC is based on a 13-week study. AF for extrapolation from Sub-chronic to chronic (ECHA 2008).
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- No allometric scaling rat to humans as inhalation (ECHA 2008). 2.5 for remaining differences not justified (ECETOC, 2010). ECHA, 2008, Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health.
- AF for other interspecies differences:
- 1
- Justification:
- No other factor required, ubiquitous metabolic pathways, equally present in rodents and humans.
- AF for intraspecies differences:
- 10
- Justification:
- Default AF for General Population (ECHA R.8, 2012)
- AF for the quality of the whole database:
- 1
- Justification:
- The key study (being rated K1) as well as the database in general are comprehensive and of high quality. No adjustment is required.
- AF for remaining uncertainties:
- 1
- Justification:
- No further adjustment necessary.
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3.75 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 80
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 300 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- No adjustment is necessary (oral to dermal).
- AF for dose response relationship:
- 1
- Justification:
- The NOAEL is reliable. No adjustment is required.
- AF for differences in duration of exposure:
- 2
- Justification:
- The NOAEL is based on a subchronic study, default AF.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Allometric scaling rat to humans AF 4 (ECHA 2008). 2.5 for remaining differences not justified (ECETOC, 2010).
- AF for other interspecies differences:
- 1
- Justification:
- No other factor required, ubiquitous metabolic pathways, equally present in rodents and humans.
- AF for intraspecies differences:
- 10
- Justification:
- Default AF for General Population (ECHA R.8, 2012)
- AF for the quality of the whole database:
- 1
- Justification:
- The key study (being rated K1) as well as the database in general are comprehensive and of high quality. No adjustment is required.
- AF for remaining uncertainties:
- 1
- Justification:
- No further adjustment necessary.
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3.75 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 80
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 300 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- The starting point is fully reliable. No adjustment required.
- AF for differences in duration of exposure:
- 2
- Justification:
- The NOAEL is based on a subchronic study, default AF.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Allometric scaling rat to humans AF 4 (ECHA 2008). 2.5 for remaining differences not justified (ECETOC, 2010), see comment below.
- AF for other interspecies differences:
- 1
- Justification:
- No other factor required, ubiquitous metabolic pathways, equally present in rodents and humans.
- AF for intraspecies differences:
- 10
- Justification:
- Default AF for General Population (ECHA R.8, 2012)
- AF for the quality of the whole database:
- 1
- Justification:
- The key study (being rated K1) as well as the database in general are comprehensive and of high quality. No adjustment is required.
- AF for remaining uncertainties:
- 1
- Justification:
- No further adjustment necessary.
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - General Population
Acute, short-term exposure
Acute systemic effects
Since the acute toxicity of N-[3-Dimethylamino)propyl]methacrylamide is low and the vapour pressure is only 0.4 Pa at 20 °C an acutely toxic exposure is not expected for the general population.
Acute local effects
N-[3-Dimethylamino)propyl]methacrylamide is strongly irritating to the eyes and sensitising to skin. DNELs for eye irritation cannot be derived. Also for sensitisation, where all EC3 values in the LLNA are above 3, a DNEL cannot be derived. For both end points only a qualitative risk assessment is required.
The substance is a skin sensitiser, hence, use of dermal protection is indicated whenever a chance for direct dermal contact exists and the potential for irreversible eye damage has to be taken into account devising handling recommendations for the general public.
Long-term exposure (dermal) - systemic effects
As in the case of workers the NOAEL of 300 mg/kg bw/d for systemic effects in a 90 d oral sub-chronic repeated dose toxicity study, OECD 408, was chosen as the point of departure for the derivation of the DNEL.
Calculation of the oral/dermal DNEL for DMAPMA – General population
Description |
Value |
Remark |
Step 1) Relevant dose-descriptor |
NOAEL: |
NOAEL for rats in a subchronic study |
Step 2) Modification of starting point |
1 |
No adjustment is necessary (oral to dermal) |
Step 3) Assessment factors |
|
|
Interspecies |
4 |
Allometric scaling rat to humans AF 4 (ECHA 2008). 2.5 for remaining differences not justified (ECETOC, 2010), see comment above. |
Intraspecies |
10 |
Default AF for General Population (ECHA R.8, 2012) |
Exposure duration |
2 |
The NOAEL is based on a subchronic study, default AF |
Dose response |
1 |
The NOAEL is reliable. No adjustment is required. (see also discussion above) |
Quality of database |
1 |
The key study (being rated K1) as well as the database in general are comprehensive and of high quality. No adjustment is required. |
DNEL |
Value |
|
based on NOAELratof |
Using a total factor (Allometric scaling and AF) of 80 ( 4 x 10 x 2 x 1) a DNELlong-term,general pop.of 3.75 mg/kg bw/d is derived. |
Long-term exposure (inhalation) - systemic effects
As in the case of workers the NOAEL of 300 mg/kg bw/d in a 90 d oral sub-chronic repeated dose toxicity study, OECD 408, was chosen as the point of departure for the derivation of the DNEL
Based on POD modifiers for route-to-route extrapolation and rat breathing volume the corrected NOAECinhalbased on a systemic NOAEL of 300 mg/kg bw/d by oral route is 130.4 mg/m³ for inhalation.
Calculation of the inhalation DNEL for DMAPMA- General Population
Description |
Value |
Remark |
Step 1) Relevant dose-descriptor |
300 mg/kg bw/d |
NOAEL in a subchronic study in rats |
Step 2) Modification of starting point |
2
1.15 m³/kg bw
- |
Oral to inhalation route-to-route extrapolation (ECHA, 2008) Correction for rat standard breathing volume vs. humans, 24 h exposure (ECHA R8 guidance p. 63, ECHA 2008) -No correction for activity driven differences of respiratory volumes required for general population (ECHA 2008). |
Modified starting point |
130.4 mg/m³ |
|
Step 3) Assessment factors |
|
|
Interspecies |
1 |
No allometric scaling rat to humans as inhalation (ECHA 2008). 2.5 for remaining differences not justified (ECETOC, 2010, in press) * |
Intraspecies |
10 |
Default AF for General Population (ECHA R.8, 2012) |
Exposure duration |
2 |
The NOAEC is based on a 13-week study. AF for extrapolation from Sub-chronic to chronic (ECHA 2008). |
Dose response |
1 |
The NOAEC is reliable. No adjustment is required. (see also discussion below) |
Quality of database |
1 |
The key study (being rated K1) as well as the database in general are comprehensive and of high quality. No adjustment is required. |
DNEL |
Value |
|
Based on NOAEL of 300 mg/kg bw in a subchronic study in rats |
Using a total factor (POD modifier and AF) of 46 (2 x 1.15 x 10 x 2) a DNELlong-term,general pop.of 6.5 mg/m3is derived. |
* ECHA, 2008/2012, Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration] response for human health
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.