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EC number: 216-343-6 | CAS number: 1562-00-1
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2008-05-20 till 2008-06-11
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: guideline-conform study under GLP without deviations
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Sodium 2-hydroxyethanesulphonate
- EC Number:
- 216-343-6
- EC Name:
- Sodium 2-hydroxyethanesulphonate
- Cas Number:
- 1562-00-1
- Molecular formula:
- C2H6O4S.Na
- IUPAC Name:
- sodium 1,4-bis[(2-ethylhexyl)oxy]-1,4-dioxobutane-2-sulfonate
- Details on test material:
- - Name of test material (as cited in study report): SODIUM 2-HYDROXYETHANESULPHONATE
- Physical state: solid, white crystalline
- Analytical purity: => 99%
- Impurities (identity and concentrations): water (0.07%)
- Purity test date: 2008-04-30
- Lot/batch No.: EK 08/116
- Expiration date of the lot/batch: 2010-12-31
- Stability under test conditions: Stable for 730 days in water at room temperature
- Storage condition of test material: At room temperature, moisture protected
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Netherlands
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 19.3 +/- 0.7 (Group 1), 20.2 +/- 0.3 (Group 2), 19.5 +/- 0.3 (Group 3), 18.9 +/- 1.2 (Group 4)
- Housing: Single caging. Cage type: Makrolon Type I, with wire mesh top
- Diet (e.g. ad libitum): pelleted standard diet, ad libitum
- Water (e.g. ad libitum): tap water from Rossdorf, ad libitum
- Acclimation period: At least 5 days prior to the start of dosing
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 30 - 70%
- Photoperiod (hrs dark / hrs light): 12 / 12
Study design: in vivo (LLNA)
- Vehicle:
- other: ethanol: deionised water (30:70)
- Concentration:
- 10%, 25%, 50%
- No. of animals per dose:
- 5 females per dose
- Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: The highest test item concentration, which can be technically used was a 50 % solution in ethanol:deionised water (30:70).
With other vehicles used, equivalent concentrations could not be achieved.
- Irritation: performed on two female mice, by topical application of concentrations of 5, 10, 25, and 50 % on one ear each on three consecutive days.
The animals did not show any signs of irritation or systemic toxicity.
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: Local Lymph Node Assay (LLNA)
- Criteria used to consider a positive response: The sensitivity and reliability of the experimental technique employed was assessed by use of a
substance which is known to have skin sensitisation properties in CBA/CaOlaHsd mice (¿-Hexylcinnamaldehyde in acetone:olive oil, 4:1 )
TREATMENT PREPARATION AND ADMINISTRATION:
25 µl was spread to the entire dorsal surface of each ear of each mouse once daily for three consecutive days. On day 6 an injection of 250 µl phosphate buffered saline (PBS) containing 78.9 µCi of 3H-methyl thymidine (3H-TdR) was made into the tail vein of each experimental mouse. Five hours
later, the draining Auricular lymph node of each ear was excised into PBS. A single cell suspension of lymph node cells was prepared from each
mouse. After washing two times with phosphate buffered saline the lymph node cells were resuspended in 5 % trichloroacetic acid and incubated at approximately +4 °C for at least 18 hours for precipitation of macromolecules. The precipitates were then resuspended in 5 % trichloroacetic acid
and transferred to plastic scintillation vials. The level of 3HTdR incorporation was then measured on a ¿-scintillation counter. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- No data.
Results and discussion
- Positive control results:
- The sensitivity and reliability of the experimental technique employed was assessed by use of a substance which is known to have skin sensitisation properties in CBA/CaOlaHsd mice.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: see Remark
- Remarks:
- Stimulation Indices (S.I.) of 0.46, 0.48, and 0.56 were determined with the test item at concentrations of 10, 25, 50 % in ethanol:deionised water (30+70), respectively. The EC3 value could not be calculated, since none of the tested concentrations induced an S.I. greater than 3.
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: See table 1
- Key result
- Parameter:
- SI
- Remarks:
- 10 % test item
- Value:
- >= 0.46
- Test group / Remarks:
- 10 %
- Remarks on result:
- other:
- Remarks:
- not sensitising
- Key result
- Parameter:
- SI
- Remarks:
- 25 % tets item
- Value:
- >= 0.48
- Test group / Remarks:
- 25 % test item
- Remarks on result:
- other:
- Remarks:
- not sensitising
- Key result
- Parameter:
- SI
- Remarks:
- 50 % test item
- Value:
- >= 0.56
- Test group / Remarks:
- 50 tets item
- Remarks on result:
- other:
- Remarks:
- not sensitising
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Conclusions:
- The test item Sodium 2-hydroxyethanesulphonate was found to be not a skin sensitiser under the described conditions.
- Executive summary:
The sensitization potential was investigated according to OECD Guideline 429.
The test item concentrations choosen for the LLNA test were 10, 25, 50 %.
No deaths occurred during the study period. No symptoms of local toxicity at the ears of the animals and no systemic findings were observed during the study period. The body weight of the animals was within the range commonly recorded for animals of this strain and age.
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