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EC number: 258-420-7 | CAS number: 53185-52-7
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 09 October 2006 - 24 October 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- 24 April 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 3-methoxy-N,N-dimethylpropionamide
- EC Number:
- 258-420-7
- EC Name:
- 3-methoxy-N,N-dimethylpropionamide
- Cas Number:
- 53185-52-7
- Molecular formula:
- C6H13NO2
- IUPAC Name:
- 3-methoxy-N,N-dimethylpropanamide
- Test material form:
- liquid
- Details on test material:
- - Appearance: Extremely pale yellow liquid
- Storage condition of test material: Approximately 4°C in the dark under nitrogen
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/Ca (CBA/CaBkl)
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: B & K Universal Ltd, Hull, UK.
- Females nulliparous and non-pregnant: yes
- Age at study initiation: Young adult animals (eight to twelve weeks old)
- Weight at study initiation: 15 - 23 g
- Housing: Animals were individually housed in suspended solid-floor polypropylene cages.
- Diet: Free access to Certified Rat and Mouse Diet (Code 5LF2, supplied by BCM IPS Limited, London, UK)
- Water: Free access to mains tap water.
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS (set conditions)
- Temperature (°C): 19 – 25
- Humidity (%): 30 - 70
- Air changes (per hr): approx. 15
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 0, 25, 50 and 100%
- No. of animals per dose:
- 4
- Details on study design:
- RANGE FINDING TESTS:
As no toxicological information was available regarding the systemic toxicity/irritancy potential of the test material, a preliminary screening test was performed using one mouse. The mouse was treated by daily application of 25 µL of the undiluted test material, to the dorsal surface of each ear for three consecutive days (Days 1, 2, 3). The mouse was observed twice daily on Days 1, 2 and 3 and once daily on Days 4, 5 and 6. Any signs of toxicity or excessive local irritation noted during this period were recorded. The bodyweight was recorded on Day 1 (prior to dosing) and on Day 6).
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: Local Lymph Node Assay
- Criteria used to consider a positive response: The test material will be regarded as a sensitiser if at least one concentration of the test material results in a threefold or greater increase in 3HTdR incorporation compared to control values. Any test material failing to produce a threefold or greater increase in 3HTdR incorporation will be classified as a "non-sensitiser".
ANIMAL ASSIGNMENT
Three groups of four animals were treated with one test substance concentration per group. One group of four animals was treated with vehicle.
TREATMENT PREPARATION AND ADMINISTRATION:
Test substance preparation: For the purpose of the study, the test material was used undiluted and freshly prepared in acetone/olive oil 4:1 by using a vortex mixer.
Rationale for vehicle: This vehicle was chosen as it produced the most suitable formulation at the required concentration.
Induction - Days 1, 2 and 3; Excision of nodes - Day 6; Tissue processing for radioacitivity - Day 6; Radioactivity measurements - Day 7; Performed according to test guidelines.
Observations:
Body weights: On Day 1 (pre-dose) and Day 6 (prior to necropsy).
Clinical signs: All animals were observed twice daily on Days 1, 2 and 3 and on a daily basis on Days 4, 5 and 6. Any signs of toxicity or signs of ill health during the test were recorded. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- Not performed.
Results and discussion
- Positive control results:
- The latest reliability check with Alpha-hexylcinnamicaldehyde indicates that the Local Lymph Node Assay as performed at SafePharm Laboratories is an appropriate model for testing for contact hypersensitivity (SI value of 4.03 and 9.13 at 10% and 25%, respectively).
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- 1.66
- Test group / Remarks:
- 25%
- Key result
- Parameter:
- SI
- Value:
- 1.8
- Test group / Remarks:
- 50%
- Key result
- Parameter:
- SI
- Value:
- 1.84
- Test group / Remarks:
- 100%
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: The radioactive disintegrations per minute per lymph node for the substance concentrations 25, 50 and 100% were 1146, 1238 and 1264, respectively. And for the vehicle the radioactive disintegrations per minute per lymph node was 688.
- Cellular proliferation data / Observations:
- DETAILS ON STIMULATION INDEX CALCULATION:
A stimulation index of less than 3 was recorded for the undiluted test material and the test material at concentrations of 50% and 25% v/v.
CLINICAL OBSERVATIONS:
There were no deaths. No signs of systemic toxicity were noted in the test or control animals during the test.
BODY WEIGHTS:
Bodyweight changes of the test animals between Day 1 and Day 6 were comparable to those observed in the corresponding control group animals over the same period.
Any other information on results incl. tables
Results Pre-screen test:
No signs of systemic toxicity were noted. Based on this information the undiluted test material and the test material at dose levels of 50% and 25% v/v were selected for the main test.
Applicant's summary and conclusion
- Interpretation of results:
- other: Not sensitising.
- Remarks:
- According to Regulation (EC) No. 1272/2008.
- Conclusions:
- In an LLNA skin sensitisation study, performed according to OECD 429 test guideline and GLP principles, 3-methoxy-N,N-dimethylpropanamide was considered not to be a skin sensitiser, as the SI appeared not to be ≥ 3 when tested up to 100% v/v.
- Executive summary:
An LLNA skin sensitisation study was performed according to OECD 429 test guideline and GLP principles. Based on the results of a pre-screen test, the test concentrations were selected at 25%, 50% and 100% v/v. There were no deaths. No signs of systemic toxicity were noted in the test or control animals during the test. Bodyweight changes of the test animals between Day 1 and Day 6 were comparable to those observed in the corresponding control group animals over the same period.
Mean DPM/animal values for the experimental groups treated with test item concentrations 25, 50 and 100% were 1146, 1238 and 1264 DPM, respectively. The mean DPM/animal value for the vehicle control group was 688 DPM. The SI values calculated for the test item concentrations 25, 50 and 100% were 1.66, 1.80 and 1.84, respectively. As the SI appeared not to be ≥ 3 when tested up to 100% v/v, 3-methoxy-N,N-dimethylpropanamide was considered not to be a skin sensitiser according to Regulation (EC) No. 1272/2008.
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