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Diss Factsheets
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EC number: 258-004-5 | CAS number: 52556-42-0
- 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
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Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 30 May 2012 - 20 June 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories B.V., Postbus 6174, 5960 AD Horst / The Netherlands
- Age at study initiation: 8-9 weeks (pretest) 9-10 weeks (main study)
- Weight at study initiation: 19.65 (pretest) 21.0+-1.6 (main study)
- Housing: group; Makrolon Type II (pretest) /III (main study) cages
- Diet: 2018C Teklad Global 18% protein rodent diet, ad libitum
- Water: ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +- 2 °C
- Humidity (%): 45-65%
- Air changes (per hr): no date
- Photoperiod (hrs dark / hrs light): 12 - Vehicle:
- other: ethanol:water (3+7 v/v)
- Concentration:
- pretest: 25 %, 50 %
main study: 0 %, 5 %, 10 %, 25 % - No. of animals per dose:
- pretest: 1
main study: 4 - Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: up to 50 % in vehicle, higher concentrations were not reachable
- Irritation: at 50 % test item concentration, erythema and swelling of the ear was observed
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: determination of incorporated 3HTdR
- Criteria used to consider a positive response: 1) the test item causes an incorporation of 3HTdR at least 3-fold or greater compared to the control, as indicated by the stimulation index.
2) the data are compatible with a conventional dose response, although allowance must be made for either local toxicity or immunological suppression.
TREATMENT PREPARATION AND ADMINISTRATION:
The test item was placed into a volumetric flask on a tared balance and ethanol:water (3+7, v/v) was quantitatively added.
Each test group of mice was treated by topical application to the dorsal surface of each ear. The application volume, 25 µl/ear/day, was spread over the entire dorsal surface of each ear. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- mean values and standard deviations were calculated for the body weights
- Positive control results:
- Historical Data (Results of the GLP Positive Control, April 2012):
25% in acetone:olive oil (4+1 v/v): S.I.: 3.73 - Key result
- Parameter:
- SI
- Remarks on result:
- other: control: 1.0 5%: 0.69 10%: 0.87 25%: 0.56
- Key result
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: control: 1438 5%: 990 10%: 1254 25%: 805
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item Sodium 3-(allyloxy)-2-hydroxypropanesulphonate (HAPS) was not a skin sensitiser under the test conditions of this study.
- Executive summary:
In the study the test item Sodium 3-(allyloxy)-2-hydroxypropanesulphonate (HAPS) dissolved in ethanol:water (3+7, v/v) was assessed for its possible skin sensitising potential.
For this purpose a local lymph node assay was performed using test item concentrations of 5, 10 and 25% (w/v). The highest concentration tested was the highest concentration that could be achieved whilst avoiding systemic toxicity and excessive local skin irritation as confirmed by a pre-experiment.
The animals did not show any signs of systemic toxicity or local skin irritation during the course of the study and no cases of mortality were observed. In this study Stimulation Indices (S.I.) of 0.69, 0.87 and 0.56 were determined with the test item at concentrations of 5, 10 and 25% (w/v) in ethanol:water (3+7, v/v), respectively. A dose response was not observed.
The test item Sodium 3-(allyloxy)-2-hydroxypropanesulphonate (HAPS) wasnot a skin sensitiserunder the test conditions of this study.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
- Migrated from Short description of key information:
A LLNA in-vivo study has been performed and no effects were observed.
Justification for selection of skin sensitisation endpoint:
only one study available.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The presented substance has no indication for skin sensitisation and is therefore not a respiratory sensitiser either (REACH technical guidance document: scheme of R7A, Fig 7.3-2). In addition, the substance has a low volatility (<0.01 kPa).
Justification for selection of respiratory sensitisation endpoint:
no study available, conclusion is drawn from ECHA Guidance document (see Discussion)
Justification for classification or non-classification
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.
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