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EC number: 939-512-2 | CAS number: 85681-55-6
- 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:
- weight of evidence
- Study period:
- 1997-09-12 to 1997-09-29
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Acetic acid, 2-sulfo-, mono-C12-14(even numbered)-alkyl esters, sodium salt
- EC Number:
- 939-512-2
- Cas Number:
- 85681-55-6
- Molecular formula:
- Not applicable for UVCB
- IUPAC Name:
- Acetic acid, 2-sulfo-, mono-C12-14(even numbered)-alkyl esters, sodium salt
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): LATHANOL LAL
- Purity: 100 % (UVCB)
- Lot/batch No.: Lot #7-20041
- Substance type: white powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Sprague-Dawley, Indianapolis, Indiana
- Age at study initiation: 6 to 10 weeks
- Weight at study initiation: 202 - 220 g
- Fasting period before study: Yes, overnight
- Housing: Individually in stainless steel cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: 4 days
ENVIRONMENTAL CONDITIONS
Temperature, humidity and light controlled room (DHEW publication No. 86-23 (NIH))
IN-LIFE DATES: From: 1997-09-12 To: 1997-09-26
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 33%
- Dosage volume: 1.01 - 1.10 g
Metal dosing cannula - Doses:
- 5 g/kg bw (1650 mg active/kg bw)
- No. of animals per sex per dose:
- five males/five females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations - frequently on day of dosing (1, 2.5 and 4 hours) and once daily thereafter; bodyweights on study initiation, at 7 and 14 days post-administration and at death.
- Necropsy of survivors performed: yes - Statistics:
- Calculations of the LC50 and 95% confidence limits: Method of moving averages, Weil CC (1952) table for convenient calculations of median effective dose (LD50 and ED50) and instruction in their use. Biometrics, 8.
Results and discussion
- Preliminary study:
- Not performed
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- < 5 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- < 1 650 mg/kg bw
- Based on:
- act. ingr.
- Mortality:
- 8/10 rats died by Day 1 of the post-administration period. The remaining two rats (2 x male) dosed with the test material survived until Day 14 of the post-administration period.
- Clinical signs:
- other: salivation and hypoactivity were observed by the 2.5 and 4 hour observation periods for the three males that died. There were no clinical signs of toxicty observed in any of the females.
- Gross pathology:
- Occurred only in animals that died during the course of the study:
External observations: bloody muzzle and wet tail
Internal observations: confined to the gastrointestinal tract, stomach and small intestine distended with gas and fluid, small intestine appeared red with haemorrhagic sites.
Applicant's summary and conclusion
- Interpretation of results:
- harmful
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute oral administration of a 33% solution of the test material (5 g/kg bw) resulted in an LD50 <1650 mg active/kg bw.
- Executive summary:
The acute oral toxicity of the test material as a 33% solution in water was assessed in male and female rats in accordance to OECD Guideline No. 401. Five male and five female rats were dosed by oral gavage with 5000 mg/kg bw (1650 mg active/kg) . After a 14 day observation period there were 8/10 mortalities. There were no treatment related effects observed on bodyweight or at gross necropsy of the remaining two male rats. The LD50 was < 1650 mg active/kg bw.
In accordance with Regulation (EC) No. 1272/2008 the substance is classified for acute toxicity by the oral route. In the absence of a derived LD50 value the substance is labelled as Category 4.
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