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Phenol, paraalkylation products with C12-rich branched olefins derived from propene oligomerisation, reaction products with sulphur monochloride and decene, reaction products with Benzoic acid, 2-hydroxy-,C14-18 alkyl dervis., polybutenyl benzenesulphonic acid, carbon dioxide and calcium hydroxide
EC number: 903-162-9 | CAS number: -
- 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 irritation / corrosion
Administrative data
- Endpoint:
- skin irritation / corrosion
- Remarks:
- other: In Vitro study conducted in accordance with OECD 439 guidance
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 18 January 2012 to 01 June 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in accordance with current guidelines and GLP compliant.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD (2010), In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method, OECD Guidelines for the Testing of Chemicals No. 439, OECD, Paris.
- GLP compliance:
- yes
Test material
- Reference substance name:
- Phenol, paraalkylation products with C12-rich branched olefins derived from propene oligomerisation, reaction products with sulphur monochloride and decene, reaction products with Benzoic acid, 2-hydroxy-,C14-18 alkyl dervis., polybutenyl benzenesulphonic acid, carbon dioxide and calcium hydroxide
- EC Number:
- 903-162-9
- IUPAC Name:
- Phenol, paraalkylation products with C12-rich branched olefins derived from propene oligomerisation, reaction products with sulphur monochloride and decene, reaction products with Benzoic acid, 2-hydroxy-,C14-18 alkyl dervis., polybutenyl benzenesulphonic acid, carbon dioxide and calcium hydroxide
- Details on test material:
- - Name of test material (as cited in study report): EC-903-162-9
- Physical state: liquid
- Expiration date of the lot/batch: 19 December 2013
- Storage condition of test material: Ambient
- Lot/batch No.: LN07006926
*EC 903-162-9 is exclusively synthesised and handled in solvent oil. Therefore testing was conducted on a sample that contained 40.8% Base oil and 59.2% EC 903-162-9.
Constituent 1
Results and discussion
In vivo
Results
- Remarks on result:
- other: EpiSkin viability of 103.09% ±13.43% (mean of triplicate values). EC 903-162-9 was demonstrated to be non-irritant when tested in the EpiSkin in vitro irritation assay.
- Irritant / corrosive response data:
- EpiSkin viability of 103.09% ±13.43% (mean of triplicate values)
Any other information on results incl. tables
MTT Direct Reduction Test (Preliminary Assay)
The test was scored by visual assessment of the formation of purple-coloured formazan. The negative control (PBS) did not reduce MTT to formazan. The positive control (eugenol) and EC 903-162-9 were reduced MTT to formazan.
EpiSkin®Irritation Test
Percentage Viability of EpiSkin® Tissues After ca 41h Recovery Time.
Treatment |
Mean viability per tissue (%) |
Mean viability per test item (%) |
SD (%) |
EC 903-162-9 (corrected) |
91.31 |
103.09 |
13.43 |
100.26 |
|||
117.71 |
|||
Aqueous SDS Solution (5%, w/v) (Positive Control) |
12.82 |
13.22 |
0.35 |
13.39 |
|||
13.44 |
|||
PBS Solution (Negative Control) |
105.31 |
100.00 |
7.75 |
91.10 |
|||
103.59 |
Negative Controls
The negative control results were similar for the three viable EpiSkin®units dosed with
Dulbecco’s PBS. Exposure to Dulbecco’s PBS resulted in a mean EpiSkin®viability of
100.00% ±7.75%.
Positive Controls
The positive control results were similar for the three viable EpiSkin® units dosed with
aqueous SDS solution (5%, w/v). Exposure to aqueous SDS solution (5%, w/v) resulted in amean EpiSkin® viability of 13.22% ±0.35%.
EC 903-162-9
Non-Viable Controls
The mean absorbance value of the three replicate non-viable tissues dosed with EC 903-162-9 was 0.148 ± 0.034. The mean absorbance value of the three replicate un-dosed non-viable tissues was 0.098±0.016. Therefore, the absorbance value for the effect of the un-removed test item was 0.050. This value was subtracted from the absorbance value of the viable tissues dosed with EC-903-162-9.
Viable Tissues
The results were similar for the three viable EpiSkin®units dosed with EC 903-162-9.
Exposure to EC 903-162-9 resulted in a mean EpiSkin®viability (corrected for effect of un-removed test item) of 103.09% ± 13.43% of the negative control value.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- In conclusion, EC 903-162-9 was demonstrated to be non-irritant when tested in the EpiSkin in vitro irritation assay.
- Executive summary:
Evaluation of skin irritation is part of the Human Health Hazard Assessment required for registration of a chemical. In this study, the irritation potential of EC 903-162-9 was evaluated using the SkinEthic EpiSkin in vitro irritation assay. Prior to the conduct of the irritation assay, a preliminary test was conducted to assess the intrinsic ability of the test item to reduce methylthiazoldiphenyl-tetrazolium bromide (MTT) to formazan. The test item was capable of MTT reduction. Therefore, non-viable control tissues were dosed in parallel with the irritation assay to quantify this effect and the results were corrected accordingly. The dermal irritation potential was assessed by applying an aliquot ca 10 µL of EC 903-162-9 to the exposed surface of three EpiSkin reconstructed human epidermis (RhE) units for 15 min. The surface area of the EpiSkin was 0.38 cm2, therefore the application rate was 26.3 µL/cm2. After the 15 min exposure period, the test item was washed from the surface of the EpiSkin using Dulbecco’s phosphate-buffered saline (PBS) and tissue swabs. The EpiSkin was then incubated for a recovery period of ca 41 h in a humidified incubator set to maintain temperature and CO2 levels of 37°C and 5%, respectively. Following incubation, the EpiSkin units were transferred to assay medium containing MTT (0.3 mg/mL) and returned to the incubator for 3 h. Biopsies of the EpiSkin membranes were then removed, added to acidified isopropanol, and refrigerated for ca 69 h in order to extract the formazan. The formazan production (cell viability) was assessed by measuring the optical density of the extracts at a wavelength of 550 nm. Three replicates of the positive control, aqueous sodium dodecyl sulphate (SDS) solution (5%, w/v) (10 µL), and the negative control, PBS (10 µL) were tested in parallel to demonstrate the efficacy of the assay. The viability of each individual EpiSkin tissue was calculated as a percentage of the mean negative control viability (defined as 100%). Exposure to EC-903-162-9 resulted in a mean EpiSkin viability of 103.09% ± 13.43% of the negative control value. Exposure to the positive control, aqueous SDS solution (5%, w/v), resulted in a mean EpiSkin viability of 13.22% ± 0.35% of the negative control value. In conclusion, EC 903-162-9 was demonstrated to be non-irritant when tested in the EpiSkin in vitro irritation assay.
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