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EC number: 207-330-6 | CAS number: 462-95-3
- 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
Endpoint summary
Administrative data
Description of key information
Not classified for Acute toxicity
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- 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: Lab not following OECD guidelines or GLP
- Qualifier:
- according to guideline
- Guideline:
- other: Internal SOP: TA300, TA120
- Deviations:
- not specified
- Principles of method if other than guideline:
- dose level tested: 5000, 2500 and 1250 mg/kg. Administrated as received. method of calculation: Weil method
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- other: CRL: CD (SD) BR
- Sex:
- male/female
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Doses:
- 5000, 2500 and 1250 mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- not specified
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 3 536 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 2 400 - 5 209
- Mortality:
- 4/5 individuals (male and females) at 5000 mg/kg.
None at the other dose levels - Clinical signs:
- other: Ataxia: at all doses, immediate to 1 hour Weaknes slight to severe: at all doses, immediate to 4 hours Prostration: at 5000 mg/kg, 1hour to 4 hours Normal state: at all doses, day 1 to day 14
- Gross pathology:
- none
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The Gavage LD50 of Ethylal on rats is 3536 mg/kg which is superior to the CLP cut off values of 2000 mg/kg
- Executive summary:
The Gavage LD50 of Ethylal on rats is 3536 mg/kg which is superior to the CLP cut off values of 2000 mg/kg
Reference
CLINICAL SIGNS |
|||
SIGN |
DOSE(mg/kg) |
TIME |
SEX |
Ataxia |
5000, 2500, 1250 |
Immediate to1 Hour
|
M,F |
Weakness-Slightto Severe |
5000, 2500, 1250 |
Immediate to 4 Hours
|
M,F |
Prostration |
5000 |
1 Hour to 4 Hours |
M,F |
Normal |
5000, 2500, 1250 |
Day 1 to Day14
|
M,F |
The test material was, at most, slightly toxic by the oral route. Abnormal clinical signs included slight to severe weakness at all dose levels, ataxia at the first hour after dosing, and prostration up to four hours after dosing at the high dose level. Eight of ten animals administered the high (5000 mg/kg) dose died within 24 hours, but all survivors appeared clinically normal from Day 1 through the observation period. The cause of death in animals dying after exposure to the test material was not determined. Treatment-related changes in those animals dying within one day of dosing included congestion, edema, and hemorrhage of the glandular gastric mucosa and reddish blue urine in the urinary bladder. No abnormalities related to administration of the test material were noted in animals surviving the observation period.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 3 536 mg/kg bw
- Quality of whole database:
- The 5 LD50 values are in the same range (all ones > the CLP cut-off value of 2000 mg/kg), which shows the high quality of the database.
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- February 17-November 11, 1986
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to OECD guideline 403 and following GLP principles
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Species:
- rat
- Strain:
- other: CRL:CD(SD)BR
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, MA
- Age at study initiation:
- Weight at study initiation: 212-250 g (males) and 192-224 g (females)
- Fasting period before study:
- Housing: Animals were singly housed in multicompartmented stainless steel mesh cages
- Diet (e.g. ad libitum): Certified feed (Agway Prolab Animal Diet (RMH 3000, pellets)) available ad lib
- Water (e.g. ad libitum): Water (Monroe County Water Authority) ad lib
- Acclimation period:
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 36-43
- Air changes (per hr): 15-20
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: To: - Route of administration:
- inhalation: vapour
- Type of inhalation exposure:
- whole body
- Vehicle:
- clean air
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
Exposures were conducted in 20 L glass bell jar inhalation chambers contained in a hood. Chambers were maintained under slight positive pressure and at 15-20 air changes per hour. Atmospheres were produced by passing metered dried oil-free compressed air over the surface of the test material contained in a 500 ml round bottom flask. Controls were treated identically to the test groups, except that exposure was to filtered air only. Temperature was determined hourly and nominal chamber concentration for the exposure was calculated.
TEST ATMOSPHERE
- Brief description of analytical method used: Chamber vapor concentrations were determined at least once per hour by a Miran IA infrared analyser equipped for automated sampling and analysis. On the morning and afternoon of the exposure, concentration of background nongaseous material was measured in the high concentration (20000 ppm) chamber relative to the control chamber in order to insure that exposure were to vapor and not aerosol.
- Samples taken from breathing zone: yes - Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 6 h
- Concentrations:
- 0, 5000, 10000 and 20000 ppm
- No. of animals per sex per dose:
- 5
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: before and after exposure and twice daily thereafter for observations; on days 0, 3, 7, 10, 14 and at necropsy for body weight
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, histopathology - Statistics:
- One-way analysis of variance (ANOVA), Bartlett's test and Duncan's multiple range test using a P value ≤ 0.05 to indicate statistical significance. LC50 and its 95% CL were estimated by probit analysis using SAS Institute Inc. Version 5, 1985 (Cary, NC)
- Preliminary study:
- Not relevant
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- 6 643 ppm
- Based on:
- test mat.
- 95% CL:
- 5 117 - 8 476
- Exp. duration:
- 6 h
- Mortality:
- Males: death of 5/5 at 20000 ppm (within 3 hours into exposure); death of 5/5 at 10000 ppm (during the 6-hour exposure); no death at 5000 ppm.
Females: death of 5/5 at 20000 ppm (within 5 hours into exposure); death of 4/5 at 10000 ppm (during the 6-hour exposure); death of 2/5 at 5000 ppm (shortly after exposure). - Clinical signs:
- other: During exposure: wobbly gait, lethargy and narcosis. Following exposure: For males: lethargy and gait disturbance at 5000 ppm. Corneal opacy for 1/5 on Day 7 to the end. For females: lethargy at 5000 ppm; narcosis following exposure at 10000 ppm All the
- Body weight:
- BW gain of all the surviving animals was comparable to control values.
- Gross pathology:
- Treatment-related changes were observed in the lungs and livers of all 3 exposure groups in females and the high- and middle-exposure groups of males. They were characterized as the incomplete collapse of lungs on thoratomy and enlarged livers. Failure of the lungs to collapse upon thoracotomy was probably caused by edema. The cause of the enlarged livers was not determined. Tissues were not collected for microscopic evaluation.
Inflammatory eye changes were observed in 4 female rats from the high dose group. Microscopic evaluation of the affected eyes revealed unilateral or bilateral congestion and edema of the ciliary body and hemorrhage of the choroid. - Other findings:
- Aerosol measurements:
Measurements obtained with the Roco Model 225 Aerosol Particle Conter (HIAC/Royco Instruments Division, Pacific Scientific, Menlo Park, CA) revealed that an aerosol was not present. - Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The 6-hour LC50 value for males and females rats combined is 6643 ppm with a 95% confidence interval of 5117 to 8476 ppm in the acute inhalation toxicity study of diethoxymethane.
- Executive summary:
An acute inhalation toxicity test was performed in the rat according to OECD guideline 401 and GLP compliance.
Groups of 5 male and 5 female rats were exposed to target vapor concentrations of 20000, 10000, 5000 or 0 ppm diethoxymethane (DEM) for 6 hours and then held for 14 days of observation. DEm caused lethargy, gait disturbance, narcosis and death in all rats, within 5 hours during exposure to 20000 ppm, and by 6 hours in all but one rat exposed to 10000 ppm. All the males and females survived exposure to 5000 ppm but 2 females died shorthly thereafter. Treatment-related gross changes in animals dying spontaneously were incomplete collapse of lungs and enlarged livers. No microscopic examinations were conducted. Other than transient narcosis, lethargy or gait disturbance following exposure, there were no compound-related clinical signs of toxicity or changes in bw gain in females which survived exposure to 5000 ppm. No treatment-related gross changes were seen in the surviving female exposed to 10000 ppm or in males exposed to 5000 ppm. Incomplete collapse of the lungs and enlarged livers were seen in females surviving exposure to 5000 ppm. Except for the microscopic examination of eyes which showed incidental inflammatory changes in 4 females exposed to 20000 ppm, no other microscopic examonations were performed. The lung and liver are sites of toxicity at these high concentrations. A no-effect level of toxicity was not determined.
The 6-hour LC50 value for males and females rats combined is 6643 ppm with a 95% confidence interval of 5117 to 8476 ppm in the acute inhalation toxicity study of DEM.
Reference
Nominal concentrations differed from the analytical ones:
Concentration | Low (ppm) | Intermediate (ppm) | High (ppm) |
Nominal | 5000 | 10000 | 20000 |
Analytical (males) | 5357 ± 413 | 9802 ± 814 | 20029 ± 219 |
Analytical (females) | 5060 ± 181 | 9393 ± 840 | 16802 ± 4054 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LC50
- Value:
- 0.032 mg/m³ air
- Quality of whole database:
- Acute inhalation toxicity was studied in an OECD 403 and GLP test.
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Lab not following OECD guidelines or GLP
- Qualifier:
- according to guideline
- Guideline:
- other: Internal SOP: TA 310, TA 160, TA 120
- Deviations:
- not specified
- Principles of method if other than guideline:
- 20 ml/kg administrated as received/ Method of calculation: Weil method
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: CRL: CD (SD) BR
- Sex:
- male/female
- Type of coverage:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Doses:
- 20 ml/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 20 mL/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: 95% CL: no range calculable
- Mortality:
- none
- Clinical signs:
- other: all normal
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Not toxic by dermal route
Reference
Skin absorption: Not evident
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 20 000 mg/kg bw
- Quality of whole database:
- Study realized in Eastman Kodak Lab. They claimed their protocols as equivalent to GLP ones, even if older studies.
Additional information
Justification for selection of acute toxicity – oral endpoint
Informations are available from different studies:
in vivo studies: LD50 of 3536 mg/kg in a Klimisch code 2 study and LD50 of 2600 mg/kg in a Klimisch code 4 study.
in silico studies: LD50 of 4600 mg/kg in rat and 3100 mg/kg in mouse (Klimisch code 2)
Read-across: LD50> 4640.9 mg/kg (Klimisch code 2)
The result from the in vivo study with a Klimisch code 2 has been selected as supported by QSAR and read-across.
Justification for selection of acute toxicity – inhalation endpoint
Acute inhalation toxicity was studied in an OECD 403 and GLP test. The 6-hour LC50 value for males and females rats combined is 6643 ppm with a 95% confidence interval of 5117 to 8476 ppm in the acute inhalation toxicity study of ethylal.
This endpoint was converted from ppm to mg/L and then the duration was converted (6h --> 4h).
As animals were exposed to vapours (and not to aerosol), ppm was converted into mg/L with the formula presented under point 3.1.2.3.2 of Guidance on the Application of the CLP Regulation (ECHA, 2011): ppm = 0.0245 mg/L /MW
6h LC50 = 6643 ppm * 104.15/24500 = 28.24 mg/L
Then, as the duration of exposure of 6 hours in the experiment is different from the duration of 4 hours on which the CLP Regulation is based, a duration extrapolation is necessary. As presented under Point R.7.4.4.1 of Chapter R.7a of Guidance on information requirements and chemical safety assessment (ECHA, 2008), extrapolation from 6 to 4 hours was performed using the modified Haber's Law ( Cn*t=k) with n = 3 for extrapolation to shorter duration than the duration for which the LC50 was observed: 4h LC50 = ((6h LC50)3* 6/4)1/3 = 32.32 mg/L.
With a CL50>20 mg/L, ethylal is not classified for its acute inhalation toxicity.
Justification for selection of acute toxicity – dermal endpoint
GLP equivalent study. Results are in the same direction as the other routes.
Justification for classification or non-classification
Acute oral toxicity: no classification with a LD50> 2000 mg/kg.
Acute inhalation toxicity: the 6 hours inhalation test revealed a DL50 of 6643 ppm.
As animals were exposed to vapours (and not to aerosol), ppm was converted into mg/L with the formula presented under point 3.1.2.3.2 of Guidance on the Application of the CLP Regulation (ECHA, 2011): ppm = 0.0245 mg/L /MW
6h LC50 = 6643 ppm * 104.15/24500 = 28.24 mg/L
Then, as the duration of exposure of 6 hours in the experiment is different from the duration of 4 hours on which the CLP Regulation is based, a duration extrapolation is necessary. As presented under Point R.7.4.4.1 of Chapter R.7a of Guidance on information requirements and chemical safety assessment (ECHA, 2008), extrapolation from 6 to 4 hours was performed using the modified Haber's Law ( Cn*t=k) with n = 3 for extrapolation to shorter duration than the duration for which the LC50 was observed: 4h LC50 = ((6h LC50)3* 6/4)1/3 = 32.32 mg/L.
With a CL50>20 mg/L, ethylal is not classified for its acute inhalation toxicity.
Acute dermal toxicity: no classification with a LD50> 20000 mg/kg.
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