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EC number: 271-668-0 | CAS number: 68603-62-3
- 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:
- 06 March 2017 - 20 November 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Study was conducted in accordance with international guidelines and in accordance with GLP. All guideline validity criteria were met.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Amines, C12-14-branched alkyl, octylbenzenesulfonates (1:1)
- Molecular formula:
- Amines, C12-branched alkyl, octylbenzenesulfonates: C27H51NO3S Amines, C13-branched alkyl, octylbenzenesulfonates: C28H53NO3S Amines, C14-branched alkyl, octylbenzenesulfonates: C29H55NO3S
- IUPAC Name:
- Amines, C12-14-branched alkyl, octylbenzenesulfonates (1:1)
- Reference substance name:
- Amines, C12-14-branched alkyl, nonylbenzenesulfonates (1:1)
- Molecular formula:
- Amines, C12-branched alkyl, nonylbenzenesulfonates: C28H53NO3S Amines, C13-branched alkyl, nonylbenzenesulfonates: C29H55NO3S Amines, C14-branched alkyl, nonylbenzenesulfonates: C30H57NO3S
- IUPAC Name:
- Amines, C12-14-branched alkyl, nonylbenzenesulfonates (1:1)
- Reference substance name:
- Amines, C12-14-branched alkyl, decylbenzenesulfonates (1:1)
- Molecular formula:
- Amines, C12-branched alkyl, decylbenzenesulfonates: C29H55NO3S Amines, C13-branched alkyl, decylbenzenesulfonates: C30H57NO3S Amines, C14-branched alkyl, decylbenzenesulfonates: C31H59NO3S
- IUPAC Name:
- Amines, C12-14-branched alkyl, decylbenzenesulfonates (1:1)
- Reference substance name:
- Amines, C12-C14-branched alkyl, benzenesulfonates C12-C15 (1:1)
- Molecular formula:
- Amines, C12-branched alkyl, benzenesulfonates C12 (1:1) C31H59NO3S Amines, C12-branched alkyl, benzenesulfonates C13 (1:1) C32H61NO3S Amines, C12-branched alkyl, benzenesulfonates C14 (1:1) C33H63NO3S Amines, C12-branched alkyl, benzenesulfonates C15 (1:1) C34H65NO3S Amines, C13-branched alkyl, benzenesulfonates C12 (1:1) C32H61NO3S Amines, C13-branched alkyl, benzenesulfonates C13 (1:1) C33H63NO3S Amines, C13-branched alkyl, benzenesulfonates C14 (1:1) C34H65NO3S Amines, C13-branched alkyl, benzenesulfonates C15 (1:1) C35H67NO3S Amines, C14-branched alkyl, benzenesulfonates C12 (1:1) C33H63NO3S Amines, C14-branched alkyl, benzenesulfonates C13 (1:1) C34H65NO3S Amines, C14-branched alkyl, benzenesulfonates C14 (1:1) C35H67NO3S Amines, C14-branched alkyl, benzenesulfonates C15 (1:1) C36H69NO3S
- IUPAC Name:
- Amines, C12-C14-branched alkyl, benzenesulfonates C12-C15 (1:1)
- Reference substance name:
- Amines, C12-14-branched alkyl, hexadecylbenzenesulfonates (1:1)
- Molecular formula:
- Amines, C12-branched alkyl, hexadecylbenzenesulfonates (1:1): C35H67NO3S Amines, C13-branched alkyl, hexadecylbenzenesulfonates (1:1): C36H69NO3S Amines, C14-branched alkyl, hexadecylbenzenesulfonates (1:1): C37H71NO3S
- IUPAC Name:
- Amines, C12-14-branched alkyl, hexadecylbenzenesulfonates (1:1)
- Reference substance name:
- Residual Amines, C12-14-tert-alkyl
- IUPAC Name:
- Residual Amines, C12-14-tert-alkyl
- Test material form:
- liquid: viscous
- Details on test material:
- Storage: Room Temperature
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Constituent 5
Constituent 6
Test animals
- Species:
- rat
- Strain:
- other: Crl:WI(Han)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Margate, UK
- Females (if applicable) nulliparous and non-pregnant: Yes
- Age at study initiation: 8-9 weeks
- Weight at study initiation: The weight variation did not exceed ± 20 %of the mean weight.
- Fasting period before study: Yes, evening before dosing (Day -1)
- Housing: The animals were housed in groups of up to five during the acclimatisation period in suspended, solid floor cages with wire lids. From the day prior to dosing (Day-1), the rats were housed in groups of three in similar cages.
Bedding was provided on a weekly basis to each cage by use of clean European soft wood bedding (Datesand Ltd., Manchester, UK).
Each batch of bedding was analysed for specific constituents and contaminants. No contaminants were present in bedding at levels which might have interfered with achieving the objective of the study. Results are retained on file at Covance.
- Diet (e.g. ad libitum): Throughout the study the animals had access to 5LF2 EU Rodent Diet 14%, which was freely available to the animals at all times, except for a period of fasting from the evening of the day prior to dosing (Day-1) until approximately 3 hours after dosing. Each batch of diet had been analysed for specific constituents and contaminants by the manufacturer. No contaminants were present in diet at levels which might have interfered with achieving the objective of the study. Results are retained on file at Covance.
- Water (e.g. ad libitum): Mains water was provided ad libitum via cage mounted water bottles. The water was periodically analysed for specific contaminants. No contaminants were present in water at levels which might have interfered with achieving the objective of the study. Results are retained on file at Covance.
- Acclimation period: The condition of the animals was assessed daily throughout the acclimatisation period of 8 to 10 days. A second inspection was performed prior to study commencement to ensure the animals were suitable for the study. Overtly healthy animals were arbitrarily allocated to the study groups at least one day prior to dosing.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24 ºC
- Humidity (%): 45-65 % RH
- Air changes (per hr): 15-20
- Photoperiod (hrs dark / hrs light): 12:12 light:dark
IN-LIFE DATES: From: 14 March 2017 To: 07 April 2017
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg
- Justification for choice of vehicle: Test item not soluble in water. Corn oil is a guideline accepted alternative vehicle.
- Lot/batch no. (if required): Not reported
- Purity: Not reported
MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg
DOSAGE PREPARATION (if unusual): The test article was dispersed in corn oil. The test article did not dissolve / suspend in purified water, but a visibly clear, yellow coloured solution was achieved in corn oil. The formulated concentrations were calculated from the selected dose level and the dose volume of 10 mL/kg. All formulations were used within two hours of preparation. The formulations were maintained on a magnetic stirrer for at least 30 minutes prior to administration to ensure homogeneity.
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: N/A - Doses:
- 2000 mg/kg (limit test)
- No. of animals per sex per dose:
- Females: 2 groups of 3 rats
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical signs were recorded immediately post-dose, at approximately 15 and 30 minutes post- dose, hourly between 1 and 4 hours post-dose (inclusive), twice daily on Days 2, 3 and 4 and once daily from the fifth to last day of the observation period. Individual body weights were recorded on Day-1 (day before dosing) and on Days 1, 4, 8 and 15.
- Necropsy of survivors performed: Yes
- Other examinations performed: clinical signs, body weight, necropsy (necropsy procedure included inspection of external surfaces and orifices, all viscera and tissue within the abdominal, thoracic and cranial cavities, free-hand sectioning of the liver and kidneys and examination of representative sections of mucosal surfaces of the stomach, small and large intestines). - Statistics:
- Not required
Results and discussion
Effect levels
- Key result
- 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:
- There were no deaths observed.
- Clinical signs:
- other: No clinical signs were observed.
- Gross pathology:
- No abnormalities were noted at necropsy of animals killed at the end of the study.
- Other findings:
- N/A
Any other information on results incl. tables
Table 2 Number of animals dead (and with evident toxicity)
Dose (mg/kg bw) |
Mortality (# dead / total) |
Time range of deaths (hours) |
Number with evident toxicity (# / total) |
||||
Male |
Female |
Combined |
Male |
Female |
Combined |
||
2000 |
- |
0 / 6 |
0 / 6 |
n/a |
- |
0 / 6 |
0 / 6 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this study, the test article, Amines, C12-14-branched alkyl, dodecylbenzenesulfonates (1:1), was considered to have no significant acute toxic risk in respect of its acute oral toxicity and did not meet the criteria for classification according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS).
- Executive summary:
OECD 423 (2017) - In an acute oral toxicity study, a group of fasted, 8-9 week old female, nulliparous Wistar rats were given a single oral dose of Amines, C12-14-branched alkyl, dodecylbenzenesulfonates (1:1) at a single dose rate of 2000 mg/kg bw (limit test) and observed for 14 days.
In the absence of mortality during the observation period, the oral LD50was estimated to be greater than 2000 mg/kg bw.
In addition, there were no treatment related clinical signs, necropsy findings or changes in body weight observed in any of the individuals.
Amines, C12-14-branched alkyl, dodecylbenzenesulfonates (1:1) did not meet the criteria for classification according to Regulation (EC) No. 1272/2008 on the Classification, Labelling and Packaging of Substances and Mixture.
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