Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 205-440-9 | CAS number: 140-90-9
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1996
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for type of information:
- Ethanol/ Ethyl Alcohol is both reagents used in the manufacture of sodium O-ethyl dithiocarbonate e. Therefore, Ethanol/ Ethyl Alcohol need to be considered in the assessment of sodium O-ethyl dithiocarbonate
Data source
Reference
- Reference Type:
- publication
- Title:
- NTP Technical Report on Toxicity Studies on Urethane in Drinking water and Urethane in 5% Ethanol Administered to F344 Rats and B6C3F1 Mice.
- Author:
- National Toxicology Program (1996)
- Year:
- 1 996
- Bibliographic source:
- NTP, Research Triangle Park, NC, USA
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OPPTS 870.3100 (90-Day Oral Toxicity in Rodents)
- Deviations:
- yes
- Remarks:
- single dose only used, no opthalmology, clinical chemistry or haematology.
- Principles of method if other than guideline:
- The study was primarily to assess the toxicity of urethane with ethanol as the vehicle. From the perspective of ethanol, the study involved a test of ethanol and a set of unexposed controls
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Sodium O-ethyl dithiocarbonate
- EC Number:
- 205-440-9
- EC Name:
- Sodium O-ethyl dithiocarbonate
- Cas Number:
- 140-90-9
- Molecular formula:
- C3H6OS2.Na
- IUPAC Name:
- sodium (ethoxymethanethioyl)sulfanide
- Test material form:
- solid: bulk
- Details on test material:
- SEX /sodium O-ethyl dithiocarbonate is produced by the reaction of an ethyl alcohol with sodium hydroxide to form alcoholate and subsequently adding carbon disulfide to form SEX/ sodium O-ethyl dithiocarbonate.
SEX /sodium O-ethyl dithiocarbonate contains Ethanol/ethyl alcohol (CAS number 64-17-5) and sodium hydroxide (CAS number 1310-73-2) which are an integral part of the substance.
Ethanol/ethyl alcohol (CAS number 64-17-5) and sodium hydroxide (CAS number 1310-73-2) are both reagents used in the manufacture of SEX /sodium O-ethyl dithiocarbonate. Therefore, Ethanol/ethyl alcohol (CAS number 64-17-5) and sodium hydroxide (CAS number 1310-73-2) need to be considered in the assessment of SEX /sodium O-ethyl dithiocarbonate.
CAS name: ethyl alcohol
EC / List name: Ethanol
IUPAC name: ethanol
EC / List no.: 200-578-6
CAS no.: 64-17-5
CAS name: sodium hydroxide
EC / List name: Sodium hydroxide
IUPAC name: sodium hydroxide
EC / List no.: 215-185-5
CAS no.: 1310-73-2
1
Test animals
- Species:
- mouse
- Strain:
- B6C3F1
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 43 - 46 days.
- Source: Taconic Farms, Germantown, NY
- Quarantine: 18-21 days.
- Animals checked for rodent virus antibodies before and after study (and found to be negative.)
- Housing: singley
- Food ad libitum: NIH-07 open formula diet (Zeigler Brothers Inc, Gardeners, PA)
- Water ad libitum
- temperature: 69-75F
- humidity: 35-65%
- Light cycle: 12 hours dark/12 hours light
- air changes: 10 per hour minimum
IN-LIFE DATES: From: Males: 10/12th December 1990 to: 12/14th March 1991. Females: 11/13th December 1990 to: 13/15th March 1991
Administration / exposure
- Route of administration:
- oral: drinking water
- Vehicle:
- water
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS: Ethanol was diluted in deionized water. Storage at 4C +/-3 for max of 3 weeks before renewal.
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Stability of dosing solutions checked throughout study and found to be within 10% of nominal concentration at all times.
- Duration of treatment / exposure:
- 90 days
- Frequency of treatment:
- 7 days/week ad libitum
Doses / concentrations
- Remarks:
- Doses / Concentrations:
5% w/v in deionized water
Basis:
nominal in water
- No. of animals per sex per dose:
- 10
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Rationale for selecting satellite groups: Satellite animals were included for haematological and clinical chemistry examination at 3 and 23 days.
- Doses were based on literature reports
Examinations
- Observations and examinations performed and frequency:
- DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: Weekly
BODY WEIGHT: Yes
- Time schedule for examinations: Weekly
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): Yes
- Time schedule for examinations: Weekly - Sacrifice and pathology:
- Complete necropsies performed on all animals
GROSS PATHOLOGY: Yes (see below)
HISTOPATHOLOGY: Yes (see below)
Organs wieghed: heart, right kidney, liver, lungs, right testis, and thymus.
Histopathologic Examination: adrenal glands, brain (three sections), clitoral glands, esophagus, eyes (if grossly abnormal), femur and marrow, gallbladder (mice only), gross lesions and tissue masses, heart, kidneys, large intestine (cecum, colon, rectum), liver (two sections), lungs, lymph nodes (mandibular and mesenteric), mammary gland, nasal cavity and turbinates (three sections), ovaries, pancreas, parathyroid glands, pituitary gland, preputial glands, prostate gland, salivary gland, seminal vesicle, small intestine (duodenum, jejunum, ileum), spinal cord and sciatic nerve (if neurologic signs were present), spleen, stomach (forestomach and glandular stomach), testes (with epididymis), thigh muscle (if neuromuscular signs were present), thymus, thyroid gland, trachea, urinary bladde,r uterus, and vagina (females in vaginal cytology studies only). - Other examinations:
- Sperm motility was assessed at termination. Source used left epididymis. Parameters examined: sperm motility, density and spermatid head count.
Vaginal cytology was assessed for all females of each group by daily (final 12 days) from vaginal smear and cell staining. Relative number of leukocytes, mucleated epithelial cells and large squamous epithelial cells uded to identify estrous stage. - Statistics:
- Statistical tests were t-tests and F-tests.
Organ and body weight: parametric multiple comparisons procedures of Williams or Dunnett. Sperm analysis: Non parametric analysis method of Shirley or Dunn.
Jonckheere's test to assess significance of dose response trends and whether a trend sensitive test (William's or Shirley's test was more appropriate for pairwise comparisons than a test that does not assume a monotonic dose response (Dunnett's or Dunn's test).
Significance tested at p<0.05 and p<0.01.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Gross pathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- not examined
- Details on results:
- ORGAN WEIGHTS
Males: relative and absolute liver weight was increased and there were increases in absoluted heart, liver, kidney and lung weight. No effects in females.
HISTOPATHOLOGY
Males: Minimal nephropathy occurred in 30% of treated animals and in 10% controls which may be biologically but is not statistically significant. Females: Minimal nephropathy occurred in 1 treated animals but not in controls which may be biologically but is not statistically significant. However, this finding is not regarded as conclusive
OTHER: Sperm count in the cauda epididymis was decreased (~30%). No effects on estrous cycle length. The only treatment-related change in female mice was a small change to the time spent in dioestrus and pro-oestrus but it was unclear whether this was significant. Cycle length was not significantly changed.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- < 9 700 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: organ weight changes, decreased sperm count, marginal nephropathy
- Dose descriptor:
- NOAEL
- Effect level:
- > 9 400 mg/kg bw (total dose)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: no clear significant biological changes seen
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- In a well conducted study that closely followed guidelines, mice were dosed exposed to ethanol in drinking water at a level of 5% for a period of 90 days. Only a single dose level was used as the study was primarily looking at the toxicology of urethane. To establish the effect of ethanol on urethane disposition, two parallel studies were run, one using distilled water as the vehicle for the urethane, the second using 5% ethanol solution as the vehicle. The study allowed a comparison of the two vehicles used. In male mice, relative and absolute liver weight was increased and there were increases in absoluted heart, liver, kidney and lung weight. There was some evidence for a marginal increase in nephropathy in male mice, but the increase was not statistically clear. Sperm count in the cauda epididymis was also decreased (~30%). Female mice showed no effects apart from a small change to the time spent in dioestrus and pro-oestrus but it was unclear whether this was either statisticall or biologically significant. Cycle length was not significantly changed. A marginal NOAEL of >5% (>9400mg/kg) is selected for females and a LOAEL of 9700mg/kg for males.
Ethanol/ Ethyl Alcohol is both reagents used in the manufacture of sodium O-ethyl dithiocarbonate . Therefore, Ethanol/ Ethyl Alcohol need to be considered in the assessment of sodium O-ethyl dithiocarbonate - Executive summary:
In a well conducted study that closely followed guidelines, mice were dosed exposed to ethanol in drinking water at a level of 5% for a period of 90 days. Only a single dose level was used as the study was primarily looking at the toxicology of urethane. To establish the effect of ethanol on urethane disposition, two parallel studies were run, one using distilled water as the vehicle for the urethane, the second using 5% ethanol solution as the vehicle. The study allowed a comparison of the two vehicles used. In male mice, relative and absolute liver weight was increased and there were increases in absoluted heart, liver, kidney and lung weight. There was some evidence for a marginal increase in nephropathy in male mice, but the increase was not statistically clear. Sperm count in the cauda epididymis was also decreased (~30%). Female mice showed no effects apart from a small change to the time spent in dioestrus and pro-oestrus but it was unclear whether this was either statisticall or biologically significant. Cycle length was not significantly changed. A marginal NOAEL of >5% (>9400mg/kg) is selected for females and a LOAEL of 9700mg/kg for males.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.