Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 943-286-0 | CAS number: 955359-35-0
- 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
Endpoint summary
Administrative data
Description of key information
The irritating potential of the substance for skin and eye irritation has been investigated in several in vitro studies, performed according to current OECD guidelines and under GLP regulation.
Based on an in vitro test for skin irritation using a reconstructed human epidermis model (RHE, SkinEthic), the test material is considered to be irritating to the skin (mean viability: 2.53%).
The eye irritating potential of the substance was investigated in a BCOP (IVIS: 18.2; no prediction can be made) and an in vitro test with reconstructed human Cornea-like Epithelium (EpiOcular; viability: 3.3%). Based on the results of these 2 in vitro tests, the substance is considered to be irritating to the eyes.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2011-04-19 to 2011-08-31
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- Adopted: 22 July 2010
- Qualifier:
- according to guideline
- Guideline:
- other: Skinethic skin irritation test -42bis Standard operating procedure (SOP) 2009
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Designation: Art. 132720
Synonym: Avodiol
Chem. Name: 1-(4-tert-Butyl-phenyl)-3-(4-methoxy-phenyl)-propane-1,3-diol
CAS-No.: 955359-35-0
Batch: 11/LE/016 K1
Purity: 95.1% (w/w)
Appearance: White, solid
Released until: May 18, 2012
Storage: Tightly closed, dark at room temperature (15 to 25°C) - Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- foreskin from a single donor
- Justification for test system used:
- standard model
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- No vehicle used in this study; The test item was applied neat to the tissues.
- Details on test system:
- CELL CULTURE
- Supplier: SkinEthic Laboratories, Lyon, France)
- Source: human keratinocytes cultured on a polycarbonate filter in conditions which permit their terminal differentiation
- Format: 24 well plate
- Batch: 11 022A 0401
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment: room temperature
- Temperature of post-treatment incubation: 37°C
REMOVAL OF THE TEST MATERIAL AND CONTROL
After the end of the treatment interval, the residual test item was removed immediately by gently rinsing with a minimum volume of 25 mL DPBS using a pipette. Excess DPBS was removed by gently shaking the inserts and blotting the bottom with blotting paper. - Control samples:
- yes, concurrent negative control
- Amount/concentration applied:
- TEST MATERIAL: 16 mg of solid test material
NEGATIVE CONTROL: 16 µL (Dulbecco`s Phosphate-Buffered Saline)
POSITIVE CONTROL: 16 µL (5% aqueous solution of sodium dodecyl sulfate in deionised water) - Duration of treatment / exposure:
- 42 min (± 1 minute)
- Duration of post-treatment incubation (if applicable):
- 42 hours (± 1 hour)
- Number of replicates:
- 3
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Experiment 1 / Run 1
- Value:
- 2.53
- Vehicle controls validity:
- not applicable
- Remarks:
- The test item was applied neat to the tissues
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Other effects / acceptance of results:
- OTHER EFFECTS:
- Visible damage on test system: none
- Direct-MTT reduction: none
- Colour interference with MTT: none
ACCEPTANCE OF RESULTS:
Acceptability of the Quality Control Data of the Skin Model with Reference to Historical Batch Data:
Negative Control:
The negative control (DPBS-buffer) OD values were 2.274, 2.217 and 2.297 (mean: 2.263, Standard Deviation: 1.80%) and, thus, in the range of ≥1.2 and ≤2.5.
After treatment with the positive control (5% aqueous solution of sodium dodecyl sulfate) the mean relative viability value was 1.02% (standard deviation: 6.01%) and fulfilled the acceptance criteria (<40%)
The standard deviation of the negative control and the positive control was ≤18%, respectively.
Test Substance Data Acceptance Criteria:
The standard deviation of the three tissues treated with the test item was 1.13% and, thus, ≤18%.
Therefore, the study fulfilled the validity criteria. - Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Remarks:
- UN GHS: No Caterory (according to OECD TG 439)
- Conclusions:
- This study was performed according to GLP and the methods applied are fully compliant with OECD TG 439. The test material is considered to be irritating to the skin based on the results of this in vitro assay.
- Executive summary:
This study was performed according to GLP and the methods applied are fully compliant with OECD TG 439. The test material is considered to be irritating to the skin based on the results of this in vitro assay.
Reference
Group | Time / [min] | Mean OD | Mean Relative viability / [%] |
Negative Control | 42 | 2.263 | 100 |
Positive Control | 42 | 0.028 |
1.26 |
Test Material |
42 |
0.057 |
2.53 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2016-11-21 to 2017-03-09
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)
- Version / remarks:
- 28 July 2015
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: MaTTek Corporation: EpiOcular Eye Irritation Test (OCL-200-EIT) for the prediction of acute ocular irritation of chemicals
- Version / remarks:
- 29 Hune 2015
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Name: Art. 132720 (RonaCare Pristine Bright)
Synonym: Avodiol
CAS-No.: 955359-35-0
Batch: EH16000620
Purity: 95 % (w/w) (HPLC)
Appearance: light cream, free flowing granules
Released until: 2018-06-30
PREPARATION OF THE TEST MATERIAL
The test item Art. 132720 was prepared as a 20% (w/v) suspension in a 0.9% sodium chloride solution. The stability in the vehicle was not investigated. The test item preparation was administered within <1 hour after preparation. - Details on test animals or tissues and environmental conditions:
- CELL CULTURE
- Supplier: MatTek Corporation (82105 Bratislava, Slovakia)
- Source: human epidermal keratinocytes cultured to form a stratified squamous epithelium
- Format: 24 well plate
- Batch: 23757
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment: 37°C
- Temperature of post-treatment incubation: 37°C
REMOVAL OF THE TEST MATERIAL AND CONTROL
After the end of the treatment interval, the residual test item was removed immediately by gently rinsing with a minimum volume of 25 mL DPBS using a pipette. Excess DPBS was removed by gently shaking the inserts and blotting the bottom with blotting paper. - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST ITEM: 50 mg
NEGATIVE CONTROL: 50 µL (deionised water)
POSITIVE CONTROL: 50 µL (methyl acetate) - Duration of treatment / exposure:
- 6 h
- Number of animals or in vitro replicates:
- duplicate
- Details on study design:
- According to guideline
- Irritation parameter:
- other: cell viability
- Run / experiment:
- mean value
- Value:
- 3.3
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- In conclusion, it can be stated that in this study and under the experimental conditions reported, the test item possesses an eye irritating potential.
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2011-06-16 to 2012-01-26
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Designation: Art. 132720
Synonym: Avodiol
CAS-No.: 955359-35-0
Batch: 11/LE/016K1
Purity: 95.1% (w/w)
Appearance: white solid
Released until: 2012-05-18
PREPARATION OF THE TEST MATERIAL
The test item Art. 132720 was prepared as a 20% (w/v) suspension in a 0.9% sodium chloride solution. The stability in the vehicle was not investigated. The test item preparation was administered within <1 hour after preparation. - Species:
- cattle
- Strain:
- not specified
- Vehicle:
- physiological saline
- Controls:
- yes, concurrent vehicle
- yes, concurrent positive control
- Amount / concentration applied:
- TEST MATERIAL: 750 µL (i.e. 150mg/750µL)
NEGATIVE / VEHICLE CONTROL: 750 µL
Designation: 0.9% sodium chloride solution
Supplier: B. Braun Melsungen AG, Germany
Batch: 0431C14
Released until: September 2013
POSITIVE CONTROL: 750 µL
Designation: Art. 814223
Synonym: Imidazole
Supplier: Merck KGaA, Germany
Batch: S5419523
Released until: August 31, 2014
Imidazole was dissolved with 0.9% sodium chloride solution to a concentration of 20% (w/v) - Duration of treatment / exposure:
- 240 minutes
- Number of animals or in vitro replicates:
- in vitro: triplicate design
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- Run 1 / Experiment 1
- Value:
- 18.2
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- not determinable
- Other effects / acceptance of results:
- OTHER EFFECTS:
- Visible damage on test system: No observations (e.g. tissue peeling, residual test chemical, non-uniform opacity patterns) were seen in a visually inspection of the corneas after treatment.
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: The treatment of the corneas with the negative control (0.9% sodium chloride solution) showed neither an increase of opacity nor an increase of pemeability
- Acceptance criteria met for positive control: After treatment with the positive control (20% Imidazole) the calculated IVIS was 137.4 and, thus, also within two standard deviations of the current historical mean of the positive control (IVIS 81.4 - 151.0). Therefore, the study fulfilled the validity criteria. - Interpretation of results:
- other: could not be determined
- Conclusions:
- According to OECD Guideline 437 no prediction on the irritation potential can be made but the test substance does not have to be classified as serious eye irritant (Eye Dam. Cat. 1)
- Executive summary:
This study was performed according to GLP and the methods applied are fully compliant with OECD TG 437. Under the conditions of the present study, no prediction on the irritation potential can be made but the test substance does not have to be classified as serious eye irritant (Eye Dam. Cat. 1)
Referenceopen allclose all
Group | Time / [h] | Mean Absorbance | Mean Relative viability / [%] |
Negative Control | 6 | 1.355 | 100 |
Positive Control | 6 | 0.247 |
18.2 |
Test Item |
6 |
0.044 |
3.3 |
Opacity |
Permeability |
IVIS |
||||
per cornea |
per group (mean value) |
|||||
Negative control |
0.9% NaCl Solution |
0.375 |
0.006 | 0.470 |
1 .0 |
|
0.710 |
0.005 |
0.785 |
||||
1.644 |
-0.002 |
1.619 |
||||
Positive control |
20% Imidazole solution |
84.301 |
3.363 |
134.748 |
137.4 |
|
103.215 |
2.891 |
146.576 |
||||
82.060 |
3.251 |
130.832 |
||||
Test item |
Art. 803057 |
11.398 |
0.043 |
12.040 |
18.2 | |
14.576 |
0.050 |
15.327 |
||||
12.116 |
1.005 |
27.187 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
Based on the available information it is justified to
- classify according to GHS Cat 2 for skin irritation
- classify according to GHS Cat 2 for eye irritation (1)
References:
1. Kolle SN, Kandárová H, Wareing B, van Ravenzwaay B, Landsiedel R. In-house validation of the EpiOcular(TM) eye irritation test and its combination with the bovine corneal opacity and permeability test for the assessment of ocular irritation. Altern Lab Anim. 2011 Sep;39(4):365–87.
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.