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EC number: 237-331-7 | CAS number: 13749-61-6
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- The study was performed between 25 October 2007 and 21 November 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Study conducted to GLP and in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not effect the quality of the relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- no
Test material
- Reference substance name:
- N-isopropylmethacrylamide
- EC Number:
- 237-331-7
- EC Name:
- N-isopropylmethacrylamide
- Cas Number:
- 13749-61-6
- Molecular formula:
- C7H13NO
- IUPAC Name:
- N-isopropylmethacrylamide
- Test material form:
- other: solid
- Details on test material:
- Sponsor's identification: N-Isopropyl methacrylamide (CAS number 13749-61-6) technical grade
Description: white crystalline solid
Batch number: 58838
Date received: 01 October 2007
Storage conditions: approximately 4°C in the dark
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Female Sprague-Dawley CD (Crl : CD® (SD) IGS BR) strain rats were supplied by Charles River (UK) Ltd. The females were nulliparous and non-pregnant.
- Age at study initiation: At the start of the study the animals were eight to twelve weeks of age.
- Weight at study initiation: 206 - 241 g. The bodyweight variation did not exceed ± 29% of the initial/mean bodyweight of any previously dosed animals.
- Fasting period before study: Overnight fast immediately before dosing and for approximately three to four hours after dosing.
- Housing: The animals were housed in groups of up to four in suspended solid-floor polypropylene cages furnished with woodflakes.
- Diet (e.g. ad libitum): Free access to food (Certified Rate and Mouse Diet) was allowed throughout the study.
- Water (e.g. ad libitum): Free access to mains drinking water was allowed throughout the study.
- Acclimation period: At least five days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Set to achieve limits of 19 to 25°C.
- Humidity (%): Set to acheive limits of 30 to 70%.
- Air changes (per hr): At least fifteen air changes per hour.
- Photoperiod (hrs dark / hrs light): lighting was controlled by a time switch to give twelve hours continuous light (06:00 to 18:00) and twelve hours darkness.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- DMSO
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 30 mg/ml (for 300 mg/kg dose level) and 200 mg/ml (for 2000 mg/kg dose level).
- Justification for choice of vehicle: Dimethyl sulphoxide was used because the test material did not dissolve/suspend in distilled water or arachis oil BP.
MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg
DOSAGE PREPARATION: For the purpose of the study the test material was freshly prepared, as required, as a solution dimethyl sulphoxide.
All animals were dosed once only by gavage, using a metal cannula attached to a graduated syringe. The volume administered to each animal was calculated according to the fasted bodyweight at the time of dosing. Treatment of animals was sequential. Sufficient time was allowed between each dose level to confirm the survival of the previously dosed animals. - Doses:
- 300 mg/kg and 2000 mg/kg
- No. of animals per sex per dose:
- 1 female at 300 mg/kg.
5 females at 2000 mg/kg. - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations were made 1/2, 1, 2, and 4 hours after dosing and then daily for fourteen days. Morbidity and mortality checks were made twice daily. Individual bodyweights were recorded on Day 0 (the day of dosing) and on Days 7 and 14.
- Necropsy of survivors performed: yes - At the end of the observation period the animals were killed by cervical dislocation. All animals were subjected to gross necropsy. This consisted of an external examination and opening of the abdominal and thoracic cavities. The appearance of any macroscopic abnormalities was recorded.
No tissues were retained.
Results and discussion
- Preliminary study:
- Dose Level 300 mg/kg:
Individual clinical observations and mortality data are given in Table 1.
Mortality: There was no death
Clinical observations: No signs of systemic toxicity were noted during the observation period.
Bodyweight: Individual bodyweights and bodyweight changes are given in Table 2. The animal showed expected gains in bodyweight over the observation period.
Necropsy: Individual necropsy findings are given in Table 3. No abnormalities were noted at necropsy.
Based on this information, a dose level of 2000 mg/kg bodyweight was selected for the main test.
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Dose Level 2000 mg/kg: Individual clinical observations and mortality data are given in Table 4.
There were no deaths. - Clinical signs:
- other: Hunched posture, lethargy, ataxia and pilo-erection were noted in all animals treated at a dose level of 2000 mg/kg. One animal appeared normal one day after dosing and the remaining animals appeared normal two days after dosing.
- Gross pathology:
- Individual necropsy findings are given in Table 6.
No abnormalities were noted at necropsy.
Any other information on results incl. tables
See attached background material for Tables 1 -6.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral median lethal dose (LD50) of the test material in the female Sprague-Dawley CD strain rat was estimated to be greater than 2000 mg/kg bodyweight.
- Executive summary:
Introduction.
The study was performed to assess the acute oral toxicity of the test material in the Sprague-Dawley CD strain rat. The method was designed to meet the requirements of the following:
• OECD Guidelines for Testing of Chemicals No 420 "Acute Oral Toxicity - Fixed Dose
Method" (200 I)
• Method BI bis Acute Toxicity (Oral) of Commission Directive 2004/73/EC
Method.
Following a sighting test at dose levels of 300 mg/kg and 2000 mg/kg, a further group of four fasted females was given a single oral dose of test material, as a solution in dimethyl sulphoxide, at a dose level of 2000 mg/kg bodyweight. Clinical signs and bodyweight
development were monitored during the study. All animals were subjected to gross necropsy.
Mortality.
There were no deaths.
Clinical Observations.
Signs of systemic toxicity noted in animals treated at a dose level of 2000 mg/kg were hunched posture, lethargy, ataxia and pilo-erection. There were no signs of systemic toxicity noted in the animal treated at a dose level of 300 mg/kg.
Bodyweight.
All animals showed expected gains in bodyweight.
Necropsy.
No abnormalities were noted at necropsy.
Conclusion.
The acute oral median lethal dose (LD50) of the test material in the female Sprague-Dawley CD strain rat was estimated to be greater than 2000 mg/kg bodyweight.
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