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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 937-960-3 | 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 corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2 - 27 May 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
- Version / remarks:
- adopted 29 July 2016
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Hess. Ministerium für Umwelt, Klimaschutz, Landwirtschaft und Verbraucherschutz, Wiesbaden, Germany
Test material
- Reference substance name:
- Reaction mass of 1-Hydroxyoctane, 2-methanoate and 1,2-Dihydroxyoctane, dimethanoate and 2-Hydroxyoctane 1-methanoate and 1,2-Dihydroxyoctane
- EC Number:
- 937-960-3
- Molecular formula:
- not applicabe (reaction mass)
- IUPAC Name:
- Reaction mass of 1-Hydroxyoctane, 2-methanoate and 1,2-Dihydroxyoctane, dimethanoate and 2-Hydroxyoctane 1-methanoate and 1,2-Dihydroxyoctane
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: EpiDerm™ (EPI-200)
- Source strain:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE)
- Model used: EpiDerm™ (EPI-200) (MatTek Corporation, Bratislava, Slovakia)
- Tissue batch number: 23338
- Delivery date: 24 May 2016
- Date of initiation of testing: 24 May 2016
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: room temperature (3 minutes exposure), 37 ± 1.5 °C (60 minutes exposure)
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: Tissues were gently rinsed with DPBS (20 times) in order to remove any residual test material.
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1 mg/mL
- Incubation time: 3 h
- Spectrophotometer: microplate reader (Versamax, Molecular Devices, SoftMax Pro Enterprise v.4.7.1)
- Wavelength: 570 nm
- Filter: without reference filter
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability: The quality of the EpiDerm™ tissue was assessed by an MTT cell viability test.
- Barrier function: The barrier function was assessed by determination of the exposure time required to reduce tissue viability by 50% (ET-50) upon application of 100 µL of 1% Triton X-100. The ET-50 value was determined to be 5.64 h.
- Contamination: The cells used to produce the EpiDerm™ tissue were screened for the presence of viruses, bacteria, yeast and other fungi.
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
Since the test substance did not directly reduce the MTT solution, an additional functional check was not performed. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount applied: 50 µL
NEGATIVE CONTROL
- Amount applied: 50 µL
POSITIVE CONTROL
- Amount applied: 50 µL
- Concentration: 8 N - Duration of treatment / exposure:
- 3 ± 0.5 and 60 ± 5 min
- Number of replicates:
- duplicates for each treatment and control group
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- mean value of 2 tissues
- Run / experiment:
- 3 minutes exposure
- Value:
- 98.8
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- mean value of 2 tissues
- Run / experiment:
- 60 minutes exposure
- Value:
- 10.5
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- OTHER EFFECTS:
- Direct-MTT reduction: The test substance did not interfere with the MTT assay (no reducing capacity).
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: The mean negative control OD, both for the 3 and 60 min exposure period, was in the range of ≥ 0.8 and ≤ 2.8.
- Acceptance criteria met for positive control: Exposure to the positive control induced a decrease in the relative absorbance as compared to the negative control, both for the 3 min exposure period (16.2%) and for the 60 min exposure period (10.7%) thus confirming the validity of the test system and the specific batch of tissue models.
- Acceptance criteria met for variability between replicate measurements: The coefficient of variation in the range 20 – 100% viability between tissue replicates was < 30%.
Any other information on results incl. tables
Table 2. Results after treatment with the test substance and controls
Test group |
Absorbance at 570 nm* |
Mean absorbance of 2 tissues |
Coefficient of variation (%) |
Rel. absorbance (% of negative control)** |
|
Tissue 1 |
Tissue 2 |
||||
3 minutes treatment |
|||||
Negative control |
1.701 |
1.598 |
1.649 |
4.4 |
100.0 |
Positive control |
0.239 |
0.297 |
0.268 |
15.4 |
16.2 |
Test substance |
1.656 |
1.605 |
1.630 |
2.2 |
98.8 |
60 minutes treatment |
|||||
Negative control |
1.619 |
1.625 |
1.622 |
0.2 |
100.0 |
Positive control |
0.198 |
0.148 |
0.173 |
20.2 |
10.7 |
Test substance |
0.169 |
0.170 |
0.170 |
0.1 |
10.5 |
* Mean of three replicate wells after blank correction
** Relative absorbance (rounded values): 100 × (absorbance test substance/positive control) / (absorbance negative control)
Applicant's summary and conclusion
- Interpretation of results:
- other: Skin Corr. Cat. 1
- Remarks:
- according to Regulation (EC) No 1272/2008
- Conclusions:
- Under the conditions of the conducted test, the test substance possessed corrosive properties towards reconstructed human epidermis tissue.
- Executive summary:
After exposure of the tissues to the test item the relative absorbance value decreased to 98.8% after 3 minutes exposure. After 1 hour exposure the relative absorbance value was reduced to 10.5%. The value for the 3 minutes exposure did not exceed the threshold for corrosivity which is defined to be 50% after the 3 minutes exposure, but the value for the 1 hour exposure was below the threshold of 15%. Therefore, the test item was considered to be corrosive.
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.