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EC number: 219-371-7 | CAS number: 2425-79-8
- 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:
- 1988
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Well documented, according to accepted guidelines.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- 1987 followed, reliability scoring based on OECD Guideline 423.
- Deviations:
- yes
- Remarks:
- -Source of test substance not reported; animals not observed at least once during the first 30 minutes; no individual data for signs and symptoms
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Version / remarks:
- 1984
- Deviations:
- yes
- Remarks:
- -Source of test substance not reported; animals not observed at least once during the first 30 minutes; no individual data for signs and symptoms
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- 1,4-bis(2,3-epoxypropoxy)butane
- EC Number:
- 219-371-7
- EC Name:
- 1,4-bis(2,3-epoxypropoxy)butane
- Cas Number:
- 2425-79-8
- Molecular formula:
- not applicable, UVCB
- IUPAC Name:
- N,N-dimethylacetamide
- Test material form:
- liquid
- Details on test material:
- - Name of test material (as cited in study report): GRILONIT RV 1806.
- Physical state: Liquid.
- Analytical purity: Technical commercial quality (excluded from Statement of Compliance).
- Lot/batch No.: DC 2106.2.
- Stability under test conditions: Test article is stable for at least 1 year; test article in dilution is stable for at least 2 hours.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: KFM-Han. Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH 4414 Fuellinsdorf / Switzerland.
- Age at study initiation: 9 weeks (males); 11 weeks (females).
- Weight at study initiation: 198 to 238 g (males); 167 to 199 g (females).
- Fasting period before study: 12 to 18 hours.
- Housing: Groups of 5 in Makrolon type-3 cages with standard softwood bedding ("Lignocel", Schill AG, 4132 Muttenz, Switzerland).
- Diet (e.g. ad libitum): Pelleted standard Kliba 343, Batch 25/88 rat maintenance diet ("Kliba", Klingentalmuehle AG, 4303 Kaiseraugst, Switzerland), available ad libitum.
- Water (e.g. ad libitum): Community tap water from Itingen, available ad libitum.
- Acclimation period: At least 1 week under laboratory conditions, after veterinary examination.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3.
- Humidity (%): 40 to 70.
- Air changes (per hr): 10 to 15.
- Photoperiod (hrs dark / hrs light): 12 / 12.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 4% solution of carboxymethylcellulose sodium salt purum in distilled water.
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 4% solution of carboxymethylcellulose sodium salt purum in distilled water.
MAXIMUM DOSE VOLUME APPLIED: 20 mL./kg body weight
DOSAGE PREPARATION (if unusual): The test article was placed into a glass beaker on a tared Mettler PK 300 balance, and the vehicle, was added. A weight by volume dilution was prepared using a homogenizer. - Doses:
- 600, 2000, and 5000 mg/kg body weight.
- No. of animals per sex per dose:
- 5 per sex per dose.
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days.
- Frequency of observations and weighing:
Mortality/Viability: 4 times during test Day 1, and daily during Days 2 to 15.
Body weights: Test Days 1 (pre-administration), 8, and 15.
- Necropsy of survivors performed: Yes.
- Other examinations performed: clinical signs, body weight, organ weights, histopathology, other: The animals were checked for the symptoms such as general behavior, respiration, eye, nose, motility, body posture, motor susceptibility, skin, etc. - Statistics:
- The LOGIT-Model (COX, Analysis of Binary Data, London 1977) was applied to estimate the toxicity value. Additionally, the 90, 95, and 99% confidence limits for the toxicity for each sex and the slope of the dose response line were estimated.
Results and discussion
- Preliminary study:
- Not applicable.
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 1 163 mg/kg bw
- 95% CL:
- 646.7 - 1 757
- Remarks on result:
- other: None
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 1 118 mg/kg bw
- 95% CL:
- 165 - 2 345
- Remarks on result:
- other: None
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 1 293 mg/kg bw
- 95% CL:
- 427 - 2 341
- Remarks on result:
- other: None
- Mortality:
- 600 mg/kg body weight group: In males, 1 death on Day 2; no death in females.
2000 mg/kg body weight group: In males, 2 deaths at Hour 2, 1 death at Hour 3, and 1 death on Day 2; In females, 2 deaths at Hour 2, 2 deaths at Hour 3, and 1 death on Day 2.
5000 mg/kg body weight group: In males, 1 death at Hour 1, 1 death at Hour 2, 1 death at Hour 3, and 2 deaths at Hour 5; In females, 4 deaths at Hour 1, 1 death at Hour 2. - Clinical signs:
- other: The following symptoms were observed: 600 mg/kg body weight: sedation, dyspnea, hunched posture, ruffled fur. 2000 mg/kg body weight: sedation, dyspnea, ataxia, ventral body position, hunched posture, spasms (males), diarrhea (males), ruffled fur. 5000 m
- Gross pathology:
- The following macroscopic organ changes were observed:
1) 600 mg/kg body weight group:
-Dead and sacrificed: no pathologic changes
2) 2000 mg/kg body weight group:
-Dead: lungs - not collapsed; no pathologic changes
-Sacrificed: no pathologic changes
3) 5000 mg/kg body weight group:
-Dead: lungs - not collapsed; no pathologic changes - Other findings:
- No other information reported.
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Remarks:
- Information Criteria used for interpretation of results: CLP (EC 1272/2008) --> Harmful if swallowed
- Conclusions:
- Based on the observations, the LOGIT-estimation applied for the acute oral toxicity of the substance in rats of both sexes observed for a period of 15 days is: LD50 (rat): 1163 mg/kg bw
- Executive summary:
The test article was administered to rats of both sexes by oral gavage, at doses from 600 to 5000 mg/kg bw.
The following death rate was observed: 10% at 600 mg/kg bw, 90% at 2000 mg/kg bw and 100% at 5000 mg/kg bw.
Based on these observations, the LOGIT-estimation applied for the acute oral toxicity of the substance in rats of both sexes observed for a period of 15 days is: LD50 (rat): 1163 mg/kg bw (for males: 1118 mg/kg bw and for females: 1293 mg/kg bw).
95 % Confidence Limits were: Males/females: 647 — 1757 mg/kg bw, males 165 — 2345 mg/kg bw and females 427 — 2341 mg/kg bw.
The following symptoms were observed:
At 600 mg/kg bw: sedation, dyspnea, hunched posture, ruffled for.
At 2000 mg/kg bw: sedation, dyspnea, ataxia, ventral body position, hunched posture, spasms (males), diarrhea (males), ruffled fur.
At 5000 mg/kg bw: sedation, coma, dyspnea, latero-abdominai position, hunched posture, spasms (males), ruffled for.
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