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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
Neurotoxicity
Administrative data
Description of key information
Subchronic (90 d) oral study in rats (OECD 408); NOAEC in FOB: 300 mg/kg bw/d (RTC, 2007).
Key value for chemical safety assessment
Effect on neurotoxicity: via oral route
Link to relevant study records
- Endpoint:
- neurotoxicity: sub-chronic oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- FOB segment in full oral guideline study
- Guideline:
- other: FOB in subchronic oral study
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): N-3-Dimethylaminopropyl methacrylamide
- Supplier: Evonik Röhm GmbH, D-64293 Darmstadt, Germany
- Substance type: organic
- Physical state at room temperature: liquid
- Stability under test conditions: Stability in water: > 160 hours in water; pure: stable for 3 month
- Storage condition of test material: +2-8 °C, light protected - Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Italy S.r.l., San Pietro al Natisone (UD), Italy
- Age at study initiation: (P) Males/females: approximately 47-49 days old
- Weight at study acclimatisation: (P) 96 - 110 g (male and female), therefore slightly outside the range indicated in the study protocol
- Fasting period before study:
- Housing: No more than 5 per cage of one sex in clear polycarbonate cages measuring 59X38.5X20 cm with a stainless steel
mesh lid and floor (Code 1354 G, Techniplast - Gazzada S.a.r.l., Buguggiate, Varese). Each cage tray held absorbent material which was
inspected and changed at least 3 times a week.
- Diet: ad libitum, commercially available laboratory rodent diet (4 RF 21, Mucedola S.r.l., Via G. Galilei, 4, 20019, Settimo Milanese (MI), Italy), except as indicated during week 13 of treatment, samples of blood were taken under conditions of food deprivation.
- Water: ad libitum, supplied via water bottles, except as indicated during week 13 of treatment, samples of blood were taken under conditions of
water deprivation.
- Acclimation period: 20 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ±2 °C
- Humidity (%): 55 ±15 %
- Air changes (per hr): 15 - 20 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hrs dark/ 12 hrs light - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: The test item was dissolved in distilled water to give the required concentrations of 7.5, 15.0 and 30.0 mg/ml.
The test item was administered orally by gavage at a dose volume of 10 ml/kg body weight.
Control animals received the vehicle alone at the same dose volume.
The dose was administered to each animal on the basis of the most recently recorded body weight and the volume administered was recorded for
each animal. - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Prior to commencement of treatment the proposed formulation procedure was checked by chemical analysis to confirm that the method was
acceptable. Stability over a 24 hour period at room temperature was assessed for content check prior to the start of treatment. Samples of the
formulations prepared at weeks 1 and 13 were analysed to check the concentration. Results of all the analyses were within the limits of acceptance
(95-105%). - Duration of treatment / exposure:
- for a minimum of 13 consecutive weeks
All animals were dosed up until the day before necropsy. - Frequency of treatment:
- daily, 7 days/week
- Remarks:
- Doses / Concentrations:
0 (vehicle alone), 75, 150 and 300 mg/kg/day
Basis:
nominal in water - No. of animals per sex per dose:
- 10/sex/dose
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- Ten male and ten female Sprague Dawley rats per test group were whole body exposed to a vapor of the test substance on 6 hours per working day for 90 days (65 exposures). The target concentrations were 20, 40, 100 and 350 ppm (corresponding to 70, 141, 352 and 1232 mg/m3). A concurrent control group was exposed to conditioned air.
- Observations and clinical examinations performed and frequency:
- Functional observation battery (FOB) was carried out on the assigned animals once before the exposure period and once against the end of the exposure period. Motor activity was measured on the same day and with the same animals as FOB was performed.
- Behaviour (functional findings):
- no effects observed
- Details on results:
- Up to the highest dose tested (300 mg/kg bw/d) there were no effects in the functional observational battery and no effects on motor activity.
- Dose descriptor:
- NOAEL
- Effect level:
- 300 mg/kg bw (total dose)
- Sex:
- male/female
- Basis for effect level:
- other: No neurotoxicity up to the highest investigated dose
- Remarks on result:
- other:
- Conclusions:
- Up to the highest dose tested (300 mg/kg bw/d) there were no effects in the functional observational battery and no effects on motor activity.
- Executive summary:
N-3-Dimethylaminopropylmethacrylamide was tested for subchronic oral toxicity. Up to the highest dose tested (300 mg/kg bw/d) there were no effects in the functional observational battery and no effects on motor activity.
(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.)
Reference
Up to the highest dose tested (300 mg/kg bw/d) there were no effects in the functional observational battery and no effects on motor activity.
Endpoint conclusion
- Dose descriptor:
- NOAEL
- 300 mg/kg bw/day
Effect on neurotoxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Effect on neurotoxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
An FOB segment was performed during a subchronic (90 d) oral study in rats with DMAPMA. In the gavage study there was no indication of neurotoxicity up to the highest dose of 300 mg/kg bw/d (RTC, 2007).
Justification for classification or non-classification
In the absence of any specific neurotoxicity up to subchronic exposure, classification for neurotoxicity is not justified.
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