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Diss Factsheets
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EC number: 948-383-1 | 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: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 12 - 16 Nov 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: ECVAM international validation study on in vitro tests for acute skin irritation: Report on the validity of the EPISKIN and EpiDerm assays and on the Skin Integrity Function Test (Altern Lab Anim. 2007 Dec.; 35 (6): 559-601)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Protocol for: IN VITRO EpiDerm™ SKIN IRRITATION TEST (EPI-200-SIT), Rev. 3/23/2009, MatTek Corporation, Ashland, USA
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Landesamt für Umwelt, Wasserwirtschaft und Gewerbeaufsicht, Mainz, Germany
Test material
- Reference substance name:
- Fatty acids, C8-10, mixed esters with adipic acid and trimethylolpropane
- EC Number:
- 306-085-3
- EC Name:
- Fatty acids, C8-10, mixed esters with adipic acid and trimethylolpropane
- Cas Number:
- 95912-89-3
- IUPAC Name:
- 95912-89-3
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: EpidermTM, reconstructed three-dimensional human epidermis model (EPI-200)
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: MatTek, In Vitro Life Science Laboratories, Bratislava, Slovakia
- Tissue batch number(s): 16854
- Delivery date: 13 Nov 2012
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 35 min at 37 °C, 25 min at room temperature
- Temperature of post-treatment incubation: 37°C
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: The tissues were rinsed in one-minute intervals.
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1mg/mL
- Incubation time: 3 h
- Spectrophotometer: Photometer MRX
- Wavelength: 570 nm
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Contamination: No biological contamination ofHIV-1 virus, Hepatitis B virus, Hepatitis C virus or bacteria, yeast and fungi were detected.
PREDICTION MODEL / DECISION CRITERIA
- The test substance is considered to be irritant to skin if the viability after 1 h exposure is less than 50%.
- The test substance is considered to be non-irritant to skin if the viability after 1 h exposure is greater than 50%. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied: 30 µL
NEGATIVE CONTROL
- Amount(s) applied: 30 µL
POSITIVE CONTROL
- Amount(s) applied: 30 µL
- Concentration: 5% solution in deionised water - Duration of treatment / exposure:
- 35 min at 37 °C, 25 min at room temperature
- Duration of post-treatment incubation (if applicable):
- 42 h
- Number of replicates:
- Triplicate tissues; from each tissue, 2 absorbance measurements after MTT incubation were performed
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Mean of 3 tissues
- Value:
- 99.4
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: The negative control OD (1.329, 1.057 and 1.049) was in the range of ≥ 1.0 and ≤ 2.5 for all three tissues. As the negative control result fell within the range defined in the acceptance criteria, the result is considered to be valid.
- Acceptance criteria met for positive control: Exposure to the positive control induced a decrease in the relative absorbance as compared to the negative control to 14.7% and thus, lower than threshold of 20%.
- Acceptance criteria met for variability between replicate measurements: The standard deviations between the three tissue replicates of the treatment group, the negative control and the positive control were 4.4%, 13.9% and 0.0%, respectively, which is ≤ 18%.
Any other information on results incl. tables
Table 2. Results of MTT assay after 1 h exposure
|
Negative control |
Test item |
Positive control |
||||||
Tissue sample |
1 |
2 |
3 |
1 |
2 |
3 |
1 |
2 |
3 |
OD570 |
1.466 1.277 |
1.113 1.087 |
1.096 1.088 |
1.298 1.179 |
1.164 1.161 |
1.140 1.146 |
0.212 0.209 |
0.210 0.212 |
0.211 0.210 |
OD570(mean) |
1.329 |
1.057 |
1.049 |
1.196 |
1.120 |
1.100 |
0.168 |
0.168 |
0.168 |
OD570(mean values of replicates±%RSD) |
1.145 ± 13.9 |
1.139 ± 4.4 |
0.168 ± 0.0 |
||||||
Viability (%) |
100 |
99.4 |
14.7 |
OD = optical density; RSD = relative standard deviation
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008
- Conclusions:
- Under the conditions of the RHE test method the test substance did not show irritant properties.
CLP: not classified
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