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EC number: 208-142-7 | CAS number: 512-42-5
- 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
- Study period:
- Jan - Feb 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- December 17, 2001
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Sodium methyl sulphate
- EC Number:
- 208-142-7
- EC Name:
- Sodium methyl sulphate
- Cas Number:
- 512-42-5
- Molecular formula:
- CH4O4S.Na
- IUPAC Name:
- sodium methyl sulphate
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Lot/batch No.of test material: KIRSCHAZ2-00182
- Content: 99.1 g/100 g
- Expiration date of the lot/batch: July 07, 2018
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
- Stability under test conditions: The stability of the test item under storage conditions over the study period was guaranteed by the sponsor, and the sponsor holds this responsibility.
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: dissolved in deionized water; The test item preparation for each test group was produced shortly before administration by stirring with a magnetic stirrer. The homogeneity of the test item preparation during administration was ensured by stirring with a magnetic stirrer.
FORM AS APPLIED IN THE TEST (if different from that of starting material): dissolved in deionized water
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- SPF
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga GmbH, Germany
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: approx. 8 weeks
- Weight at study initiation: Animals of comparable weight (± 20% of the mean weight (182.8 g))
- Fasting period before administration: Feed was withdrawn from the animals at least 16 hours before administration, but water was available ad libitum.
- Housing: single
- Diet: ad libitum
- Water: tap water ad libitum
- Acclimation period: at least 5 days before administration
ENVIRONMENTAL CONDITIONS
- Temperature: 22°C ± 3°C
- Humidity: 30 – 70%
- Air changes (per hr): approx. 10
- Photoperiod (hrs dark / hrs light): 12 / 12 (6.00 a.m. – 6.00 p.m. / 6.00 p.m. – 6.00 a.m.)
IN-LIFE DATES: From: 23.01.2017 To: 14.02.2017
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- deionized
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 20 g/100 mL
- Amount of vehicle (if gavage): 10 mL/kg bw
- Justification for choice of vehicle: Aqueous preparation corresponds to the physiological medium.
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: limit test; Because no mortality occurred, 2000 mg/kg bw were administered to 3 further female rats in the second step. - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 6 (3 first step + 3 second step)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Body weight determination: Individual body weights shortly before administration (day 0), weekly thereafter and on the last day of observation.
Clinical observations: Clinical signs for each animal were recorded several times on the day of administration and at least once during each workday thereafter.
Mortality: A check for any dead or moribund animals was made at least once each workday.
Pathology: Necropsy with gross-pathology examination was performed on the last day of the observation period after sacrifice by CO2-inhalation in a chamber with gradually increasing concentrations.
Histology: No histological examinations were performed.
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- No mortality occurred in both 2000 mg/kg bw test groups.
- Clinical signs:
- other: In both test groups no clinical signs were observed during clinical examination.
- Gross pathology:
- There were no macroscopic pathological findings in the animals sacrificed at the end of the observation period (6 females).
Any other information on results incl. tables
Tab. 1: Mortality
Dose (mg/kg bw): |
2000 |
2000 |
Sex: |
female |
female |
Administration: |
1 |
2 |
No. of animals: |
3 |
3 |
Mortality (animals): |
No mortality |
No mortality |
Tab. 2: Body weights
Individual body weight changes |
||||||||||
Dose (mg/kg bw): |
2000 |
2000 |
||||||||
Administration: |
1 |
2 |
||||||||
Animal No.: |
R |
R |
R |
Mean weight |
Standard- deviation |
R |
R |
R |
Mean weight |
Standard- deviation |
52 |
53 |
54 |
68 |
69 |
70 |
|||||
Body weight at study day (g): |
|
|
|
|
|
|
|
|
|
|
0 |
189 |
182 |
182 |
184.3 |
4.04 |
178 |
178 |
188 |
181.3 |
5.77 |
7 |
206 |
207 |
208 |
207.0 |
1.00 |
198 |
194 |
213 |
201.7 |
10.02 |
14 |
211 |
213 |
213 |
212.3 |
1.15 |
230 |
205 |
230 |
221.7 |
14.43 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this study the median lethal dose of the test substance after oral administration was found to be greater than 2000 mg/kg bw in female rats.
- Executive summary:
In an acute oral toxicity study performed according to the Acute Toxic Class Method, 2000 mg/kg bw of the undiluted test item were administered by gavage to two test groups of three fasted Wistar rats each (6 females).
Neither clinical signs nor mortality were observed in both test groups dosed with 2000 mg/kg bw.
The body weights of all animals increased within the normal range throughout the study period. There were no macroscopic pathological findings in the animals sacrificed at the end of the observation period.
The acute oral LD50 was calculated to be LD50, oral, rat > 2000 mg/kg bw.
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