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EC number: 610-472-5 | CAS number: 49707-23-5
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well performed study according to OECD technical guidelines.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Version / remarks:
- 92/69/EEC
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: 93/21/EEC
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Certificate attached to the study report.
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- N-(2,2-dimethoxyethyl)prop-2-enamide
- EC Number:
- 610-472-5
- Cas Number:
- 49707-23-5
- Molecular formula:
- C7 H13 N1 O3
- IUPAC Name:
- N-(2,2-dimethoxyethyl)prop-2-enamide
- Details on test material:
- - Name of test material (as cited in study report): N-(2,2-Dimethoxyethyl)acrylamide
- Chemical name: N-Acryloylaminoacetaldehyddimetylacetal, NAAADA
- Batch number: Z 3165-04
- Description: yellowish liquid
- Water solubility: completely mixable at 25°C
- Density: 1.065 g/cm3 at room temperature (determined in the testing facility)
- Storage: the test article was stored in a closed vessel at =<10°C in a refrigerator in the dark
- The test article was made to the room temperature prior using
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Wiga GmbH, D-97320 Sulzfeld
- Age at study initiation (start of acclimatisation): 35 - 42 days
- Weight 2days after arriving: Males: 191.5g +/- 6.9g (3.6%), n = 15
Females: 163.1g +/- 4.0g (2.5%), n = 15
- Fasting period before study: over night before administration
- Hygiene status upon supply: SPF
- Diet (e.g. ad libitum): Altromin 1326, pelleted standard diet, ad libitum, Batch: 140998/1206
- Water (e.g. ad libitum): tap water, ad libitum (municipal supply), Makrolon bottles, changed daily
- Acclimation period: 8/14/19 days before administration according to the different dose groups
- Identification: Ear notches and cage labelling showing the animal number, study number, dose, sex, time of dosing and end of observation period
- Randomisation: Animals were assigned according to random numbers one day prior to administration
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.5 - 25°C
- Humidity (%): 30 - 60%
- Air changes (per hr): Air conditioned, no further details given
- Photoperiod (hrs dark / hrs light): 12hrs / 12hrs
IN-LIFE DATES: From: To:
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- - single dose
- in each case after an overnight fasting
- by oral gavage using a metal catheter and disposable plastic syringes
- individual doses were adjusted via the administered volume of the original test article according to the body weight on the day of administration - Doses:
- Males [mg/kg body weight]: 2000 (0.188mL per 100g b.w.), 1500 (0141mL per 100g b.w.), 1000 (0.094mL per 100g b.w.)
Females [mg/kg body weight]: 1300 (0.122mL per 100g b.w.), 1150 (0.108mL per 100g b.w.), 1000 (0.094mL per 100g b.w.) - No. of animals per sex per dose:
- 5 animals per sex and dose
- Control animals:
- no
- Details on study design:
- See "Any other information on materials and methods incl. tables"
- Statistics:
- Body weights: Calculation of group mean values and standard deviations.
LD50 values: Probit analysis (Weber, E.: Grundriß der bilogischen Statistik, G. Fischer Verlag, Jena 1972)
Results and discussion
Effect levelsopen allclose all
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- ca. 1 199 mg/kg bw
- Remarks on result:
- other: See remarks on reults
- Sex:
- male
- Dose descriptor:
- approximate LD50
- Effect level:
- ca. 1 600 mg/kg bw
- Remarks on result:
- other: See remarks on reults
- Mortality:
- See tables 1 and 2
Comment on LD50, see "Remarks ond results including table and figures" - Clinical signs:
- other: Please see attached tabels 3 and 5 for further details on individual animals. The animals of all dose groups showed apathy at least at one day of administration. The most clear symptoms in the animals of the two higher dose grous were decreasing of body w
- Gross pathology:
- Please refer to the attached tables 4 and 7 for further details.
In the surviving animals macroscopic pathological findings were not observed except for a slight haemorrhagic lung in the male animal No5 of the middle dose group. There were no gross lesions in the animals of the low dose group except for one of the died female animals with a slight lung emphysema. In the two higher dose groups the lungs of all died animals showed emphysema, in many cases with haemorrhagic regions. The mouth was agglutinated with saliva in all died animals of these dose groups. The contents of the stomach and small intestine showed that the animals did not ingest feed until death.
Any other information on results incl. tables
Table 1: Mortality
Dose group (mg/kg b.w.) |
Male animals |
Female animals |
||
Number of died animals of 5 |
Mortality in % |
Number of died animals of 5 |
Mortality in % |
|
2000 |
5 |
100 |
- |
- |
1500 |
2 |
40 |
- |
- |
1300 |
- |
- |
4 |
80 |
1150 |
- |
- |
1 |
20 |
1000 |
0 |
0 |
1 |
20 |
Results of probit analysis by E. Weber |
||||
Chiquadrat comparison: χ2(0.95; DF), table: χ2, calculated: Homogeneity |
|
0.4 1.3 heterogeneous |
||
Regression evaluation: |
Y = a + bX Y: data in probit; X: data in log dose |
|||
Slope*(b) Intercept(a) Degree of Freedom (DF) t-value(5% DF) Correction term g b is: |
|
14.8 -44.1 1 12.7 62.6 valid |
||
LD50(mg/kg b.w.) Confidence interval |
|
1199 not available |
*Slope = Regression coefficient
Because of the all-or-none mortality response in male animals of the high or low dose group, it was not possible to calculate a precise LD50 value according to the probit analysis by E. Weber. However, from these data the LD50 value can be reasonably estimated to be about 1600mg/kg b.w.
The regression calculation was not valid in the female animals because the results havea too great variation arount the regression straight line. The LD50 value was calculated to be about 1200mg/kg b.w. without valid slope and condifdence interval.
A test continuation with a further dose group is not justified for ethical reasons because the result is unambiguous for the classification in accordance with the German "Chemical Act" (in each case 200=<LD50<2000 mg/kg b.w.).
Table 2: Time of Death
|
Dose group [mg/kg b.w.] |
Animal No |
Time of Death Hours after administration |
Males |
2000 |
1, 5 |
> 5 hours < 22 hours |
|
2 |
approximately 29 hours |
|
|
4 |
approximately 30 hours |
|
|
3 |
> 30 hours < 46 hours |
|
1500 |
4 |
approximately 27 hours |
|
|
3 |
> 32 hours < 48 hours |
|
Females |
1300 |
5 |
> 8 hours < 24 hours |
|
2, 4 |
> 32 hours < 48 hours |
|
|
3 |
55 hours, moribundly killed |
|
1150 |
4 |
> 30 hours < 46 hours |
|
1000 |
4 |
> 30 hours < 46 hours |
Applicant's summary and conclusion
- Interpretation of results:
- harmful
- Remarks:
- if swallowed Criteria used for interpretation of results: EU
- Conclusions:
- See "Overall remarks" for conclusion and interpretation of results.
- Executive summary:
Acute oral toxicity of N-(2,2 -Dimethoxyethyl)acrylamide was tested in male and female Charles River Wistar rats. The test article was administered at the single doses of 2000, 1500 and 1000 mg/kg body weight (b.w.) in male animals and of 1300, 1150 and 1000 mg/kg b.w. in female animals by gavage (five male animals and five female animals per group).
All animals were examined for mortality, clinical signs and body weight gain. The pathological alterations of organs were examined in the died animals shortly after the death or in the surviving animals at the end of a 14-day observation period.
The LD50 values were estimated to about 1600 mg/kg b.w. in male animals and to about 1200 mg/kg b.w. in female animals.
Mortalities occurred in the night after administration until the second night after administration.
The most clear clinical symptoms were apathy, decreasing of body weight in animals which died during the course of investigation, tremor, bloody rhinorrhea and increased salivation. All these symptoms were dose dependently increased.
The body weight gain was not affected in the animals of the low dose groups, but it was slightly delayed in the surviving animals of the two higher dose groups.
The most clear macroscopic pathological findings in all died animals were pulmonary emphysema, in many cases with hemorrhagic regions and the mouths were agglutinated with saliva.
The pulmonary emphysema could be seen as cause of death. The tremor is a sign of the central action of the test substance.
In accordance with the results of this test and in compliance with the criteria of Annex IV of Council Directive 93/21/EEC of 27th April 1993 N-(2,2 -Dimethoxyethyl)acrylamide must be classified as harmful (symbol of danger:Xn) and must be labelled with R22 “Harmful if swallowed”.
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