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EC number: 217-442-7 | CAS number: 1852-16-0
- 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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 26 June 2006 to 13 October 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- N-(butoxymethyl)acrylamide
- EC Number:
- 217-442-7
- EC Name:
- N-(butoxymethyl)acrylamide
- Cas Number:
- 1852-16-0
- Molecular formula:
- C8H15NO2
- IUPAC Name:
- N-(butoxymethyl)prop-2-enamide
- Test material form:
- liquid
- Details on test material:
- - Physical state: Clear liquid
- Storage conditions of test material: Room temperature and humidity. Avoid prolonged storage above 100 °F.
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: The pre-test body weight range was 2.1 - 2.9 kg
- Housing: 1 per cage in suspended wire cages. Bedding was placed beneath the cages and changed at least three times/week.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: At least three days
ENVIRONMENTAL CONDITIONS
- Temperature: Not reported, the room was temperature controlled
- Photoperiod: 12 hour light / dark cycle
IN-LIFE DATES:
- From: Animals were received 21 June, 05 July, 26 July and 23 August 2006
- To: Not reported; date of last data collection was 04 September 2006
Administration / exposure
- Type of coverage:
- other: occlusive at the lower dose levels, semi-occlusive at the highest dose
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
Prior to application of the test article, the back and sides of each animal were clipped free of hair and remained intact.
- Area of exposure: Approximately 10 %
- Type of wrap if used: Test material was applied under a 4 ply porous gauze dressing measuring 10 x 15 cm at the lower dose levels. The top dose was applied to the prepared site on top of the gauze dressing. The torso was wrapped with plastic sheeting in an occlusive manner for animals dosed at 500, 1000 and 1500 mg/kg. Animals dosed at 2000 mg/kg were wrapped in a semi-occlusive manner. Plastic sheeting was secured with non-irritating tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The test sites were wiped, not washed
- Time after start of exposure: After 24 hours
TEST MATERIAL
Doses were based on the sample weight as calculated from the specific gravity.
- Amount applied:
1.3 to 1.5 cc at 500 mg/kg bw
2.5 to 2.8 cc at 1000 mg/kg bw
3.3 to 3.6 cc at 1500 mg/kg bw.
4.6 to 6.0 cc at 2000 mg/kg bw
VEHICLE
The test material was used as received - Duration of exposure:
- 24 hours
- Doses:
- 500, 1000, 1500 and 2000 mg/kg
- No. of animals per sex per dose:
- Initially, five healthy males were dosed at 500 mg/kg of body weight.
At the sponsor's request and to further characterise the test material, three additional groups of five males were dosed at 1000, 1500 and 2000 mg/kg. - Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 7 days
- Frequency of observations and weighing: Animals dosed at 500 mg/kg were observed at 1, 4 and 24 hours post-dose and animals dosed at 1000, 1500 and 2000 mg/kg were observed at 1, 4 and 24 hours post-dose for mortality, toxicity and pharmacological effects. Animals were observed once daily thereafter for six days for mortality only. Body weights were recorded pre-test and at termination.
- Necropsy of survivors performed: No.
- Other examinations performed: The test sites were scored for dermal irritation at 24 hours post-dose and on day 7 using the Numerical Draize scoring code. The skin was also evaluated for ulceration and necrosis or any evidence of tissue destruction. Additional signs were described.
Erythema and eschar formation:
0: No erythema
1: Very slight erythema (barely perceptible)
2: Well-defined erythema
3: Moderate to severe erythema
4: Severe erythema (beet redness) to slight eschar formation (injuries in depth)
Oedema formation:
0: No oedema
1: Very slight oedema (barely perceptible)
2: Slight oedema (edges of area well-defined by definite raising)
3: Moderate oedema (edges raised approximately 1 millimetre)
4: Severe oedema (raised more than 1 millimetre and extending beyond the area of exposure)
Results and discussion
Effect levels
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- None, all animals survived
- Clinical signs:
- other: All animals appeared normal at post-dose assessments up to 24 hours.
- Gross pathology:
- Not performed.
- Other findings:
- - At 500 mg/kg: Dermal effects ranged from very slight to slight on Day 1 and from absent to well-defined on Day 7.
- At 1000 mg/kg: Dermal effects ranged from absent to well-defined on Day 1 and from absent to very slight on Day 7.
- At 1500 mg/kg: Dermal effects ranged from absent to very slight on Days 1 and 7.
- At 2000 mg/kg: Dermal effects ranged from very slight to slight on Day 1 and from absent to very slight on Day 7.
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified in accordance with EU criteria
- Conclusions:
- The LD50 of the test material is greater than 2000 mg/kg body weight.
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.
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