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EC number: 224-116-8 | CAS number: 4203-89-8
- 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:
- Initiation date Oct.-30-1986 (dose range finding) and Nov.-19-1986 Completion date Nov:-06-1986 (dose range finding) and May:-14-1986 (microscopic examination)
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 2-(1-oxa-4-azaspiro[4.5]dec-4-yl)ethyl methacrylate
- EC Number:
- 224-116-8
- EC Name:
- 2-(1-oxa-4-azaspiro[4.5]dec-4-yl)ethyl methacrylate
- Cas Number:
- 4203-89-8
- Molecular formula:
- C14H23NO3
- IUPAC Name:
- 2-{1-oxa-4-azaspiro[4.5]decan-4-yl}ethyl 2-methylprop-2-enoate
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- Purity: > 99%; major impurity p-methoxyphenol (100 ppm)
Batch no: 860930-DT4
Solubility: Soluble in ethanol and toluene, decomposes in water
Storage: At ambient temperature in the dark in the presence of silica gel
Stability: Stable in the absence of moisture
Appearance: Clear slightly yellow liquid
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Fourty young adult rats of the Wistar strain (approximately 7 weeks old upon arrival, SPF-quality, randomly bred) were obtained from Charles River Wiga GmbH, Sulzfeld, FRG (instead from Iffa-Credo, Brussels, Belgium as mentioned in the study protocol). Date of arrival at the animal house : October 21, 1986 . The animals were identified by means of ear tags. The quarantine period was 7 days. At least five days prior to dosing the animals were individually housed in polycarbonate cages (acclimation period). The body weights of the males on day 0 ranged from 327 to 424 g and those of the female s from 218 to 269 g: The bedding material, purified sawdust (Woody Clean), was received from The Broekman Institute, Someren, The Netherlands. The animals had free access to tap-water and standard laboratory animal diet (RMH-B, pellet diameter 10 mm), which was obtained from Hope Farms, Woerden, The Netherlands. The animal room temperature was maintained at 18-21°C (on several occasions the temperature ranged between 18-19°C for a period ranging from 6 -40 hours which was below 22 ± 3 °C as mentioned in the study protocol) and the relative humidity at 49-70 percent: The artificial light sequence was 12 hours light, 12 hours dark: Feed was withheld overnight prior to dosing until approximately 3.5-4.5 hours after administration of the test substance.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- On the day of dosing undiluted test substance was administered as a single dose using a stainless steel stomach cannula. The dose volume (ml/kg body weight) was calculate d as follows: dose (g/kg body weight)/specific gravity (g/ml). The specific gravity used was 1.04 g/ml. The day of dosing was considered as day 0.
- Doses:
- 3200, 4200, 5600 and 7400 mg/kg body weight
- No. of animals per sex per dose:
- Dose range-finding investigation: 1 male and 1 female per dose
Limit study: 5 males and 5 females per dose
Full study: 5 males and 5 females per dose - Control animals:
- no
- Details on study design:
- Dose range finding investigation:
Each dose group, comprising one male and one female, receives a single dose of the test substance. The dose levels are determined based on the availability of toxicity data. Generally, the study duration is 7 days; however, this may be changed if considered necessary.
Limit study:
One dose group, comprising five males and five females, receives a dose of 5000 mg/kg body weight. The study duration is 14 days; however, this period may be extended when considered necessary (determined by the toxic reaction, rate of onset and length of recovery period).
Full study:
At least three dose levels are selected in such a manner that a range of responses to treatment will be elicited and that the generated data will be sufficient to permit adequate assessment of the LD50 value. Each dose group comprises five males and five females. The study duration is 14 days; however, this period may be extended when considered necessary (determined by the toxic reactions, rate of onset and length of recovery period).
PERIODICAL AND TERMINAL DETERMINATIONS (OBSERVATIONS):
During cage-side observations particular attention is paid to changes in the skin, fur, eyes and mucous membranes, as well as to behavioural pattern, tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma. For the main study cage-side observations are performed once every two hours on the day of dosing and once every day thereafter. For the dose range finding investigation cage-side observations are performed frequently on the day of dosing and once every day thereafter. If any animal dies during the study the time of death is recorded as precisely as possible. With exception of weekends and holidays a daily mortality check is performed (usually in the evening).
Individual body weights of the animals are determined on the day of dosing, weekly thereafter and at death (if found dead 24 hours or more following dosing). At the end of the study all surviving animals are sacrificed by C02- asphyxiation and subjected to autopsy. Gross morphological changes are recorded. Abnormal organs and tissues of animals surviving more than 24 hours will be subjected to histopathological examination if it is considered that such examination will yield additional useful information.
Results and discussion
- Preliminary study:
- In order to establish an appropriate dose range four groups of animals, each comprising 1 male and 1 female, were dosed with an oral dose of the test substance at 1300, 2400, 4200 and 5600 mg/kg body weight, respectively. Mortalities occurred in the 5600 mg/kg body weight (both animals) dose group. Signs of toxicity were lethargy, teary eyes and haematuria. The observation period was 7 days.
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 3.5 other: g/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 2.6 - <= 4
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 3.6 other: g/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 1.3 - <= 4.5
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 3.4 other: g/kg bw
- Based on:
- test mat.
- Mortality:
- The incidence of mortalities for the sexes combined from low to high dose group was 4, 7, 10 and 10. There was no evident sex related effect: All deaths occurred within 4 days.
- Clinical signs:
- other: Signs of toxicity were body weight loss for animals found dead. Other signs of toxicity were lethargy, stagger, teary eyes, noisy respiration, laboured respiration, slow respiration, tremors, emaciation, comatose, rough coat, pale skin and blood (crusts)
- Gross pathology:
- Macroscopic examination of animals at necropsy revealed autolysis; yellow, watery or bloody stomach content, slimy covering of the stomach mucosa, enlarged stomach, hyperaemia, erosion or haemorrhage of the stomach, firm white/grey areas in the stomach; watery, slight green watery, bright slimy, yellow or bloody intestinal content, gas accumulation in the intestines, haemorrhage of the intestines; pink or dark red liver; small spleen; enlarged kidneys, grey/green discolouration of the kidneys; petechiae or haemorrhage of the thymus; swollen lungs, hyperaemia of the lungs and haemorrhage of the lungs. Microscopic examination of the stomach of one female of the 4200 mg/kg group revealed an ulcus.
Any other information on results incl. tables
Sex |
LD50 Value (mg/kg body weight) |
95% Confidence Intervalb.)(mg/kg body weight) |
Slope |
Ga.) |
Combined |
3495 |
2641-3997 |
9.545 |
0.4345 |
Males |
3586 |
1336-4490 |
8.905 |
0.8002 |
Females |
3415 |
NCc.) |
10.746 |
1.0244 |
a) G<1, 95 % confidence intervalvalid according to Finney.
b) Calculated with U-distribution.
c) Not calculated,G> 1.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- LD50 = 3500 mg/kg bw
- Conclusions:
- Four groups of Wistar rats, each comprising 5 males and 5 females, received a single oral dose of Nourycryl MA 128 at 3200, 4200, 5600 and 7400 mg/kg body weight, respectively. The incidence of mortalities for the sexes combined from low to high dose group was 4, 7, 10 and 10. There was no evident sex related effect. All deaths occurred within 4 days of dosing. Signs of toxicity were body weight loss for animals found dead. Group mean body weight for survivors were restored by the end of the study. For surviving a nimals these signs were reversible since as of day 8 no more abnormalities were observed during the 14-day observation period: Major test substance related gross abnormalities at necropsy were: haemorrhage of the stomach, intestines, thymus and lungs; abnormal stomach and/or intestinal content; enlarged or grey/green discolouration of the kidneys and a pink or dark red liver. Microscopic examination of the stomach of one female of the 4200 mg/kg group revealed an ulcus. The LD50 value for the sexes combined amounted to approximately 3.5 g/kg body weight (95 % confidence interval 2.6-4.0 g/kg body weight): The LD50 value for males alone amounted to approximately 3.6 g/kg body weight and for females alone was estimated at 3.4 g/kg body weight.
- Executive summary:
Four groups of Wistar rats, each comprising 5 males and 5 females, received a single oral dose of Nourycryl MA 128 at 3200, 4200, 5600 and 7400 mg/kg body weight, respectively. The incidence of mortalities for the sexes combined from low to high dose group was 4, 7, 10 and 10. There was no evident sex related effect. All deaths occurred within 4 days of dosing. Signs of toxicity were body weight loss for animals found dead. Group mean body weight for survivors were restored by the end of the study. For surviving animals these signs were reversible since as of day 8 no more abnormalities were observed during the 14-day observation period: Major test substance related gross abnormalities at necropsy were: haemorrhage of the stomach, intestines, thymus and lungs; abnormal stomach and/or intestinal content; enlarged or grey/green discolouration of the kidneys and a pink or dark red liver. Microscopic examination of the stomach of one female of the 4200 mg/kg group revealed an ulcus. The LD50 value for the sexes combined amounted to approximately 3.5 g/kg body weight (95 % confidence interval 2.6-4.0 g/kg body weight): The LD50 value for males alone amounted to approximately 3.6 g/kg body weight and for females alone was estimated at 3.4 g/kg body weight.
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