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EC number: 276-337-4 | CAS number: 72102-30-8
- 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:
- From 27. Nov. 2017 to 01. Dec. 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Version / remarks:
- OECD Guidelines for the Testing of Chemicals Part 431, adopted 29. Jul. 2016
“In vitro Skin Corrosion: reconstructed human epidermis (RHE) test method” - Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Fatty acids, vegetable-oil, Me esters, sulfurized
- EC Number:
- 276-337-4
- EC Name:
- Fatty acids, vegetable-oil, Me esters, sulfurized
- Cas Number:
- 72102-30-8
- IUPAC Name:
- Fatty Acids, vegetable-oil, Me-Esters, sulfurized
- Test material form:
- liquid
- Details on test material:
- - Density: 0.95 g/mL
- Batch no.: 71012767
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: EpiDermTM tissues were procured from MatTek In Vitro Life Science Laboratories, Bratislava.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EPI-200-SIT
- Tissue batch number(s): 25861
- Delivery date: 28. Nov. 2017
- Date of initiation of testing: 29. Nov. 2017
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37 ± 1°C
- Temperature of post-treatment incubation: 37 ± 1°C
REMOVAL OF TEST MATERIAL AND CONTROLS
- Observable damage in the tissue due to washing: none
- Modifications to validated SOP: none
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 5 mg/mL
- Incubation time: 3 h
- Spectrophotometer: Anthos Reader 2010 Flexi
- Wavelength: 570 nm
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability:
NUMBER OF REPLICATE TISSUES: 3
NUMBER OF INDEPENDENT EXPERIMENTS TO DERIVE FINAL PREDICTION: 1
DECISION CRITERIA
After the treatment with the test item, the mean value of relative tissue viability was in-creased to 102.9 %. This value is above the threshold for skin irritation potential (50%). Test items that induce values above the threshold of 50% are considered non-irritant to skin. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- One plate (3 tissues) was used as negative control; each tissue was treated with 30 µL DPBS buffer, a nylon mesh was added in order to ensure sufficient contact with the tis-sue surface.
One plate was used as positive control; each tissue was treated with 30 µL 5% SDS-solution, a nylon mesh was added in order to ensure sufficient contact with the tissue surface.
One plate was used for treatment with the test item:
30 µL test item were applied, and a nylon mesh was added in order to ensure sufficient contact with the tissue surface. - Duration of treatment / exposure:
- 1 hour
- Duration of post-treatment incubation (if applicable):
- 42 hours 45 minutes
- Number of replicates:
- 3
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- >= 100.4 - <= 107.1
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes
- Acceptance criteria met for positive control: yes
- Acceptance criteria met for variability between replicate measurements: yes
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- After treatment, the respective substance was rinsed from the tissues. Then, cell viability of the tissues was evaluated by addition of MTT, which can be reduced to a blue forma-zan. Formazan production was evaluated by measuring the optical density (OD) of the re-sulting solution. After treatment with the negative control, the absorbance values were within the required acceptability criterion of mean OD ≥ 0.8 and ≤ 2.8 for both treatment intervals thus show-ing the quality of the tissues. The OD was 1.7 (3 minutes experiment) and 1.6 (1 hour ex-periment). The positive control showed clear corrosive effects for both treatment intervals. The mean relative tissue viability value was reduced to 6.1 % for the 1 hour treatment. After 3 minutes treatment with the test item, the mean value of relative tissue viability was increased to 102.6 %. This value is above the threshold for corrosion potential (50%). After 1 hour treatment, the mean value of relative tissue viability was increased to 105.0 %. This value, too, is above the threshold for corrosion potential (15%).
Therefore, Fatty Acids, vegetable-oil, Me-Esters, sulfurized is considered non-corrosive to skin in the Reconstructed Human Epidermis (RHE) Test Method. - Executive summary:
One valid experiment was performed.
Three tissues of the human skin model EpiDermTM were treated with Fatty Acids, vegetable-oil, Me-Esters, sulfurized for 60 minutes.
The test item was applied directly to each tissue and spread to match the tissue size (0.63 cm2; as indicated by the supplier).
DPBS-buffer was used as negative control and 5% SDS solution was used as positive control.
After treatment with the negative control, the mean absorbance values was within the required acceptability criterion of 0.8 ≤ mean OD ≤ 2.8, OD was 1.7. The positive control showed clear irritating effects. The mean value of relative tissue viability was reduced to 2.9 % (required: ≤ 20%).
The variation within the tissue replicates of negative, control, positive control and test item was acceptable (required: ≤ 18%).
After the treatment with the test item, the mean value of relative tissue viability was increased to 102.9 %. This value is above the threshold for skin irritation potential (50%). Test items that induce values above the threshold of 50% are considered non-irritant to skin.
Therefore, Fatty Acids, vegetable-oil, Me-Esters, sulfurized is considered
non-irritant to skin in the Reconstructed human Epidermis (RhE) Test Method.
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