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EC number: 606-078-8 | CAS number: 186321-96-0
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 18 September 2012 to 25 March 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Fully GLP compliant and in accordance with current test guidelines
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
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
- GLP compliance:
- yes
Test material
- Reference substance name:
- Fatty acids, tall-oil, reaction products with bisphenol A, epichlorohydrin, glycidyl tolyl ether and triethylenetetramine
- EC Number:
- 606-078-8
- Cas Number:
- 186321-96-0
- IUPAC Name:
- Fatty acids, tall-oil, reaction products with bisphenol A, epichlorohydrin, glycidyl tolyl ether and triethylenetetramine
- Test material form:
- other: Viscous semi-solid
- Details on test material:
- Name: TOFA_TETA_PAA_BADGE_CGE_Adduct
CAS number: 186321-96-0
Batch number: WA520
Purity: 100%
Expiry date: 28 Feb 2014
Date of receipt: 03 Sep 2012
Storage: stored in a sealed container, at 15 to 25ºC, in the dark.
Constituent 1
Test animals
- Species:
- other: Not applicable
- Strain:
- other: Not applicable
- Details on test animals or test system and environmental conditions:
- Three-dimensional human skin model, comprising a reconstructed epidermis with a functional stratum corneum supplied by MatTek Corporation, Ashland, Massachusetts, USA. Human keratinocytes are used to construct the epithelium. Multiple layers of viable epithelial cells are present under a functional stratum corneum. The stratum corneum is multi-layered with the necessary lipid profile to produce a functional barrier. The containment properties of the model prevent the passage of material around the stratum corneum to the viable model tissue. The skin model was supplied free of contamination with bacteria, mycoplasma and fungi.
Test system
- Type of coverage:
- not specified
- Preparation of test site:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- Three tissues per test article, negative control and positive control were treated by application of 30 µL of the negative control, 30 µL of the positive control and approximately 70 mg of test article onto the surface of the tissues.
- Details on study design:
- The tissues were incubated at 37 ± 1ºC, 5 ± 1% Carbon Dioxide for a 35 ± 1 minute period. The plates were then removed from the incubator and placed into a sterile hood until the 60 minute treatment period was complete for each tissue.
Following treatment, substances were removed by washing the tissues. The tissues were then placed on the appropriate medium and incubated for 42 hours. The protocol stated that the incubation period would be 24 hours. This deviation from protocol was considered not to have affected the integrity or outcome of the study as this was an error in the protocol and the correct incubation period was used for this test system.
To evaluate whether residual test article was binding to the tissue, a functional check (using freeze-killed control tissue) was performed. Freeze-killed tissues were prepared by placing untreated EpiDerm constructs in the -20°C freezer overnight. The freeze-killed tissues were allowed to thaw once at room temperature and placed back in the freezer until required.
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- other: other: relative group mean viability
- Value:
- 7.2
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Time point: 60 minutes treatment period. Max. score: 100.0. Reversibility: no data. (migrated information)
In vivo
- Irritant / corrosive response data:
- The relative group mean viability for the test article was 7.2%.
The relative group mean viability for the positive control was 4.9%.
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: not specified
- Conclusions:
- The test article, TOFA_TETA_PAA_BADGE_CGE_Adduct, was considered not to be corrosive to the in vitro skin model EpiDermTM, but was considered to be an irritant to the in vitro skin model EpiDermTM SIT (EPI-200).
- Executive summary:
The purpose of the study was to determine whether the test article, TOFA_TETA_PAA_BADGE_CGE_Adduct, caused dermal corrosion or irritation. Dermal corrosion refers to the production of irreversible tissue damage in the skin following the application of a test material. Dermal irritation refers to the production of reversible inflammatory changes in the skin following the application of a test material.
An in vitro skin corrosivity assay (EpiDermTM) was initially conducted. This demonstrated that the test article did not have the potential to cause corrosion to the skin therefore an in vitro skin irritation assay (EpiDermTM SIT (EPI-200)) was conducted.
EpiDermTM SIT (EPI-200) inserts were treated with test article, negative control (phosphate buffered saline (PBS)) and positive control (5% w/v sodium dodecyl sulphate (SDS)) for 60 minutes. At the end of the treatment period, the tissues were washed with PBS and cell viability was assessed using the MTT assay. The skin irritation potential was classified according to the remaining cell viability obtained after test article treatment.
The relative group mean viability for the test article was 7.2% and for the positive control was 4.9%.
The test article, TOFA_TETA_PAA_BADGE_CGE_Adduct, was considered not to be corrosive to the in vitro skin model EpiDermTM, but was considered to be an irritant to the in vitro skin model EpiDermTM SIT (EPI-200).
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