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Diss Factsheets
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EC number: 203-704-8 | CAS number: 109-78-4
- 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:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions . High mortality in lowest dose group.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: "Appraisal of the safety of chemicals in foods , drugs and cosmetics, FDA"
- Principles of method if other than guideline:
- Method: in accordance with "Appraisal of the safety of chemicals in foods, drugs and cosmetics, FDA"
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- 3-hydroxypropiononitrile
- EC Number:
- 203-704-8
- EC Name:
- 3-hydroxypropiononitrile
- Cas Number:
- 109-78-4
- Molecular formula:
- C3H5NO
- IUPAC Name:
- 3-hydroxypropanenitrile
- Details on test material:
- - Name of test material (as cited in study report): Ethylencyanhydrin
- Substance type: aliphatic nitrile
- Physical state: liquid
-Density : 1.050 g/ml (20°C)
- Analytical purity: as supplied by producer: purity in the test report not mentioned, but probably > 98,5% ; colourless liquid
- pH 5.5
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: SPF Wistar rats, Zucht Winkelmann, Paderborn, Germany
- Age at study initiation: no data
- Weight at study initiation: 160 - 205 g
- Fasting period before study: 16 hours
- Housing: single housing
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C
- Humidity (%): 45 - 55 %
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- - Maximum dose volume applied: 15.9 ml/kg
- Rationale for the selection of the starting dose: preliminary study for range finding - Doses:
- 6.3, 7.94, 10.0, 12.6, 15,9 ml/kg bw equals 6.615, 8.337, 10.50, 13.23 and 16.7 mg/kg bw (calculated with a density of 1.050 g/ml)
- No. of animals per sex per dose:
- 5f/5m per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighting: 20 min, 1h, 3h, 24h, 48h, 7d, 14d
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights, histopathology, other: reflexes, emotions, consciousness, central
symptoms, autonomous functions, tone - Statistics:
- Probit analysis
Results and discussion
- Preliminary study:
- No further information mentioned in the study report.
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- ca. 6 000 mg/kg bw
- Remarks on result:
- other: 14 days LD50
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 229 - < 6 960 mg/kg bw
- Remarks on result:
- other: 14 days LD50
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- ca. 9 335 mg/kg bw
- Remarks on result:
- other: 24 hours LD50
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 9 345 - 10 164 mg/kg bw
- Remarks on result:
- other: 24 hours LD50
- Mortality:
- In the first an second dose group mortalities occurred within 3 days (6/10 and 7/10), in the third and the fourth dose group mortalities occurred
within 48h (9/10 and 10/10), in the highest dose group all rats died within 24h (10/10). - Clinical signs:
- Hemorrhages of the intestinal and gastric mucosa
- Body weight:
- In the first and second dose group, rats gained ~21% of weight during 14 days of postexposure time (37,50g/175.00g =>21.4% ;
38.67g/183.00g=>21.1%), in the third dose group, gain weight in the same time was determined to only 5.4% (for the only surviving rat), for the
highest dose groupes no data were obtained.
Remark: At the end oft the post exposure period of 14 days all surviving animals showed again normal body weight gain. - Gross pathology:
- Decrease in activity, reduction of pain reflexes, decreased tonus of extremities, disturbance in coordination, slight hyperemia, ptosis, piloreaction
Any other information on results incl. tables
Table (I) Mortality (mortalities occurred within 7 days p.a.) |
|
Table(II) Weight development |
|
Remark: At the end of the post exposure period of 14 days all surviving animals showed normal body weight gain.
After application of the test substance, animals exhibited dose-dependent decrease in activity, decreased tonus of extremities, marked disturbance in coordination, slight hyperemia and piloerection; in high dose groups ptosis was observed; symptoms occured 20 min after application of TS; 24 h after treatment the surviving rats showed usual habit again.
Survival after 14 days: 6.3 ml/kg: 4 out of 10; 7.94 ml/kg: 3 out of 10; 10.0 ml/kg: 1 out of 10; in higher dose groups, all rats died within 48 h. Acute and delayed mortalities showed by dissection intense hemorrhages of the intestinal and gastric mucosa.Those animals, which were killed humanly at the end of the study, showed by dissection no macroscopic changes in organs.
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Remarks:
- Migrated information
- Conclusions:
- According to the test result: LD50(14days) ca. 6000 mg/kg bw the test substance ethylene cyanohydrin has to be classified as nontoxic in respect of its acute oral toxicity.
- Executive summary:
In an acute oral toxicity study, groups of fasted male and female SPF Wistar rats were given a single oral dose of Ethylene cyanohydrin > 98.5 % at doses of 6.615, 8.337, 10.50, 13.23 and 16.7 mg/kg bw and observed for 14 days.
Oral LD50 Combined = 5.71 ml/kg bw equals ca. 6000 mg/kg bw (95% C.I. not available)
GHS Category 5 ranges from 2000 -5000 mg/kg bw and represents the lowest hazard category for classifying the acute oral toxicity of a chemical substance. ("Criteria for hazard Category 5 are intended to enable the identification of the test substancese which are of relatively low acute toxicity hazard but which, under certain circumstances may present a danger to vulnerable populations". (OECD guideline 425 annex 4)).
Ethylene cyanohydrin is of very low oral toxicity based on this LD50 test in males and females.
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