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EC number: 273-105-4 | CAS number: 68937-98-4 This substance is identified by SDA Substance Name: C14-C18 and C12-C20 unsaturated alkyl alkene and C14-C18 and C12-C20 unsaturated alkyl hydroxy sulfonic acid sodium salt and SDA Reporting Number: 03-059-04.
- 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
Acute toxicity, oral (rat): 300 mg/kg bodyweight < LD50 < 2000 mg/kg bodyweight
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
- Study period:
- 06 September 2017 - 02 Ocober 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Envigo RMS
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 140-169 g
- Fasting period before study: Overnight fasting immediately before dosing and for approximately 3 to 4 hours after dosing
- Housing: groups of 4
- Diet: ad libitum
- Water: ad libtum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25°C
- Humidity (%): 30-70%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 30-200 mg/mL
- Amount of vehicle : 10mL
MAXIMUM DOSE VOLUME APPLIED: 10mL/kg
- Doses:
- 300mg/kg, 2000mg/kg
- No. of animals per sex per dose:
- 5 females were treated at a dose level of 300 mg/kg
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 30mins, 1,2,4 hours, and then daily up to 14 days
- Frequency of weighing: day 0, 7 and 14
- Necropsy of survivors performed: yes - Statistics:
- not specified
- Preliminary study:
- dose level of 2000mg/kg - the animal was found dead on day 1
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- ca. 300 - ca. 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- 1 aminal found dead at a dose level of 2000 mg/kg
No mortality at dose level of 300 mg/kg - Clinical signs:
- other: Hunched posture was noted at the 4 hours after dosing at dose level of 2000 mg/kg No signs of systemic toxicity at the dose level of 300 mg/kg
- Gross pathology:
- Dark liver and dark kidneys at dose level of 2000 mg/kg
No abnormalities were noted at the dose level of 300mg/kg - Other findings:
- not specified
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The acute oral median lethal dose (LD50) of the test item was estimated to be in the range or 300-2000mg/kg body weight (GHS- category 4)
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
An acute oral toxicity study was conducted (Envigo Research Limited, 2017, Study KM39QF) to assess the toxicity of Sulfonic acids, C14-18-alkane hydroxy and C12-20-alkapolyene and C14-18-alkene and C12-20-alkene hydroxy, sodium salts following a single oral administration. The study was conducted in accordance with OECD and EC test guidelines, and in compliance with GLP.
In accordance with the acute toxic class method, one fasted female rat was administered a single dose of 2000 mg/kg and one fasted female rat was administered a single dose of 300 mg/kg Sulfonic acids, C14-18-alkane hydroxy and C12-20-alkapolyene and C14-18-alkene and C12-20-alkene hydroxy, sodium salts by oral gavage.
As the rats at the 2000 mg/kg dose level died, a further four female rats were dosed at 300 mg/kg. No rats in the group died at 300 mg/kg.
It was concluded that the acute median lethal dose in rats following oral administration of Sulfonic acids, C14-18-alkane hydroxy and C12-20-alkapolyene and C14-18-alkene and C12-20-alkene hydroxy, sodium salts was between 300 mg/kg and 2000 mg/kg.
No acute dermal toxicity and acute inhalation toxicity study was conducted.
Justification for classification or non-classification
The oral LD50 was found to fall in the range 300 mg/kg to 2000 mg/kg. In accordance with the Regulation (EC) 1272/2008 Appendix 1 (table 3.1.1) the substance will be classified as acute toxicity category 4 by the oral route. The applicable hazard phrase is "H302: Harmful if swallowed".
No data are available for the acute toxicity hazard by the dermal or inhaled routes.
No sub-lethal effects were observed in the organs of Rats receiving the 300 mg/kg dose in the above Acute Oral Toxicity study. It is considered that there is no basis to apply a classification for Specific Target Organ Toxicity following a Single Exposure (STOT-SE).
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