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EC number: 945-909-1 | CAS number: 69415-01-6
- 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
In an in vitro skin irritation potential study, the relative mean tissue viability after 60 min of exposure and 42 h post-incubation was > 50%. The test item is therefore classified as “non-irritant” in accordance with UN GHS “No Category”.
In an in vitro skin corrosion potential study, the test item showed no corrosive effects. The mean relative tissue viability (% negative control) was³ 50% (99.4%) after 3 min treatment and³ 15% (92.2%) after 60 min treatment. In this study under the given conditions the test item showed no corrosive effects. The test item is classified as “non-corrosive“.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- September 2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Name: Reaction mass of
meso-2-{[4-(2-{4-[(oxiran-2-yl)methoxy]phenyl}-1,1-dichloroethylidene-2-yl)phenoxy]methyl}oxirane
and
(2RS)-2-({4-2-(4-{[(2RS)-oxiran-2-yl]methoxy}phenyl)-1,1-dichloroethylidene-2-yl]phenoxy}methyl)oxirane
Alternative Name: Bisphenol C Epoxy
CAS: 69415-01-6
Batch No.: GRM 193K01
Aggregate State at RT: viscous liquid
Colour: yellow
Storage Conditions: room temperature
Stability: stable at recommended storage conditions
Expiry Date: 03 September 2021 - Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Details on test system:
- The test will be carried out with the reconstituted three-dimensional human skin model EpiDerm (MatTek). This skin model consists of normal (non-cancerous), human-derived epidermal keratinocytes (NHEK) which have been cultured to form a multilayered, highly differentiated model of the human epidermis. The NHEK are cultured on chemically modified, collagen-coated cell culture inserts (Millicell). The EpiDerm skin model exhibits in vivo-like morphological and growth characteristics which are uniform and highly reproducible. It consists of organised basal, spinous, granular and cornified layers analogous to those found in vivo.
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- Controls
Controls will be set up in parallel to the test item cultures in order to confirm the validity of the test.
Negative Control
Distilled water (Aqua dest.)
Positive Control
8 N Potassium Hydroxide (KOH; CAS No.: 1310-58-3)
Dose Groups
1. Negative control 50 µL distilled water
2. Positive control 50 µL 8 N KOH
3. Test Item 50 µL (undiluted) - Duration of treatment / exposure:
- 3 minute and 60 minute experiment
- Duration of post-treatment incubation (if applicable):
- 3 min and 60 min experiment: after the 3 h MTT incubation period the MTT solution will be aspirated. The wells will be refilled with PBS and the PBS will be aspirated. The rinsing will be repeated twice and the tissues will be dried. Then the inserts will be transferred into 12-well “extraction plates“. 2 mL of isopropanol will be pipetted into each insert, thus the insert will be covered from both sides. The extraction plates will be sealed in zip-bags to inhibit isopropanol evaporation. Extraction will be carried out either over night without shaking at room temperature or, alternatively, at least 2 h with shaking at room temperature.
After the extraction period the inserts will be pierced with an injection needle to allow the extracts to run through the tissues into the corresponding wells. Then the inserts will be discarded and the extraction plates will be placed on a shaker for 15 min.
Per each tissue 3 x 200 µL aliquots of the extract will be transferred into a 96-well plate and OD will be measured at 570 nm without reference wavelength in a plate spectrophotometer using isopropanol as a blank. - Number of replicates:
- The test will be performed on a total of 4 tissues per dose group, 2 replicates for each treatment period (3 min and 60 min exposure time).
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Mean at 3 min
- Value:
- 99.4
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Mean at 60 min
- Value:
- 92.2
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- The potential of the test item to induce skin corrosion was analysed by using the three-dimensional human skin model EpiDerm, comprising a reconstructed epidermis with a functional stratum corneum.
In the present study Reaction mass of meso-2-{[4-(2-{4-[(oxiran-2-yl)methoxy]phenyl}-1,1-dichloroethylidene-2-yl)phenoxy]methyl}oxirane and (2RS)-2-({4-2-(4-{[(2RS)-oxiran-2-yl]methoxy}phenyl)-1,1-dichloroethylidene-2-yl]phenoxy}methyl)oxirane was applied topically to the EpiDerm tissue for 3 min and 60 min followed by immediate determination of cytotoxic effects via MTT reduction assay.
Corrosivity potential of the test item was predicted from the relative mean tissue viabilities obtained after both treatment periods had been compared to the corresponding negative control tissues.
The mixture of 25 mg test item per 1 mL MTT medium showed no reduction of MTT as compared to the solvent. The mixture did not turn blue/purple. Therefore, NSMTT equalled 0%.
The mixture of 25 mg test item per 300 µL Aqua dest. and per 300 µL isopropanol showed no colouring as compared to the solvent. Therefore, NSC equalled 0%.
The test item showed no non-specific reduction of MTT and no relevant colouring potential after mixture with aqua dest. and with isopropanol. Therefore, no additional controls for correction of possible false-negative results were necessary.
The test item showed no corrosive effects. The mean relative tissue viability (% negative control) was 50% (99.4%) after 3 min treatment and 15% (92.2%) after 60 min treatment. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- In this study under the given conditions the test item showed no corrosive effects. The test item is classified as “non-corrosive“.
- Executive summary:
In the present study the skin corrosivity potential of Reaction mass of meso-2-{[4-(2-{4-[(oxiran-2-yl)methoxy]phenyl}-1,1-dichloroethylidene-2-yl)phenoxy]methyl}oxirane and (2RS)-2-({4-2-(4-{[(2RS)-oxiran-2-yl]methoxy}phenyl)-1,1-dichloroethylidene-2-yl]phenoxy}methyl)oxirane was analysed. Since corrosive chemicals are cytotoxic after a short time exposure to the stratum corneum of the epidermis the cytotoxic effects of the test item on EpiDermÔ, a reconstituted three-dimensional human epidermis model, were determined. Hereby, the test item was applied topically. Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from MTT after a 3 min and 60 min exposure period and compared to those of the concurrent negative controls.
The mixture of 25 mg test item per 1 mL MTT medium showed no reduction of MTT as compared to the solvent. The mixture did not turn blue/purple.Therefore, NSMTT equalled 0%.
The mixture of 25 mg test item per 300 µL Aqua dest.and per 300 µL isopropanolshowed no colouring as compared to the solvent.Therefore, NSC equalled 0%.
The test item showed no non-specific reduction of MTT and no relevant colouring potential after mixture with aqua dest. and with isopropanol. Therefore, no additional controls for correction of possible false-negative results were necessary.
The test item showed no corrosive effects. The mean relative tissue viability (% negative control) was³ 50% (99.4%) after 3 min treatment and³ 15% (92.2%) after 60 min treatment.
In this study under the given conditions the test item showed no corrosive effects. The test item is classified as “non-corrosive“.
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- September 2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Name: Reaction mass of
meso-2-{[4-(2-{4-[(oxiran-2-yl)methoxy]phenyl}-1,1-dichloroethylidene-2-yl)phenoxy]methyl}oxirane
and
(2RS)-2-({4-2-(4-{[(2RS)-oxiran-2-yl]methoxy}phenyl)-1,1- dichloroethylidene-2-yl]phenoxy}methyl)oxirane
Alternative Name: Bisphenol C Epoxy
CAS: 69415-01-6
Batch No.: GRM193K01
Aggregate State at RT: viscous liquid
Colour: Yellow
Storage Conditions: room temperature
Stability: stable at recommended storage conditions
Expiry Date: 03 September 2021 - Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Details on test system:
- The test will be carried out with the reconstituted three-dimensional human skin model EpiDerm (MatTek). This skin model consists of normal human epidermal keratinocytes (NHEK) which have been cultured to form a multilayered, highly differentiated model of the human epidermis. The NHEK are cultured on chemically modified, collagen-coated cell culture inserts (Millicell). The EpiDerm epidermis model exhibits in vivo-like morphological and growth characteristics which are uniform and highly reproducible. It consists of organised basal, spinous and granular layers and a multi-layered stratum corneum analogous to patterns found in vivo.
- Control samples:
- yes, concurrent negative control
- yes, concurrent vehicle
- Amount/concentration applied:
- 1. Negative control 30 µL DPBS
2. Positive control 30 µL 5% SDS solution
3. Test Item 30 µL (undiluted) - Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Mean
- Value:
- > 50
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- The potential of the test item to induce skin irritation was analysed by using the three-dimensional human epidermis model EpiDerm (MatTek) comprising a reconstructed epidermis with a functional stratum corneum.
In the present study Reaction mass of meso-2-{[4-(2-{4-[(oxiran-2-yl)methoxy]phenyl}-1,1-dichloroethylidene-2-yl)phenoxy]methyl}oxirane and (2RS)-2-({4-2-(4-{[(2RS)-oxiran-2-yl]methoxy}phenyl)-1,1-dichloroethylidene-2-yl]phenoxy}methyl)oxirane was applied topically to the EpiDerm tissue for 60 min followed by a 42 h post-incubation period and immediate determination of cytotoxic effects via MTT reduction assay.
Irritant potential of the test item was predicted from the relative mean tissue viabilities obtained compared to the corresponding negative control tissues concurrently treated with DPBS.
The mixture of 25 mg test item per 1 mL MTT medium showed no reduction of MTT compared to the solvent. The mixture did not turn blue/purple. Therefore, NSMTT equaled 0%.
The mixture of 25 mg of the test item per 300 µl aqua dest. and per 300 µL isopropanol showed no colouring detectable by unaided eye-assessment. Therefore, NSC equaled 0%.
The test item showed no non-specific reduction of MTT and no relevant colouring potential after mixture with aqua dest. and with isopropanol. Therefore, no additional controls for correction of possible false-negative results were necessary.
The test item showed no irritant effects. The mean relative tissue viability (% negative control) was > 50% (111.9%) after 60 min treatment and 42 h post-incubation.
The controls confirmed the validity of the study. The mean absolute OD570 of the three negative control tissues was 0.8 and ≤ 2.8 (1.563). The mean relative tissue viability (% negative control) of the positive control was < 20% (5.8%). Standard deviation of viability of replicate tissues of all dose groups was ≤ 18% (0.5% - 14.3%). - Interpretation of results:
- GHS criteria not met
- Conclusions:
- In this study under the given conditions the test item showed no irritant effects. The test item is therefore classified as “non-irritant” in accordance with UN GHS “No Category”.
- Executive summary:
In the present study the skin irritant potential of Reaction mass of meso-2-{[4-(2-{4-[(oxiran-2-yl)methoxy]phenyl}-1,1-dichloroethylidene-2-yl)phenoxy]methyl}oxirane and (2RS)-2-({4-2-(4-{[(2RS)-oxiran-2-yl]methoxy}phenyl)-1,1-dichloroethylidene-2-yl]phenoxy}methyl)oxirane was analysed.The EpiDerm™-Standard Model (EPI-200™), a reconstituted three-dimensional human epidermis model, was used as a replacement for the Draize Skin Irritation Test (OECD TG 404,[7]) to distinguish between UN GHS “Category 2” skin irritating test substances and not categorized test substances (“No Category”) which may be considered as non-irritant. Hereby, the test item was applied topically. Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from MTT after a60 min exposure and 42 h post-incubation periodand compared to those of the concurrent negative controls.
The mixture of 25 mg test item per 1 mL MTT medium showed no reduction of MTT compared to the solvent. The mixture did not turn blue/purple. Therefore, NSMTT equaled 0%.
The mixture of 25 mg of the test item per 300 µl aqua dest. and per 300 µL isopropanol showed no colouring detectable by unaided eye-assessment.Therefore, NSC equaled 0%.
The test item showed no non-specific reduction of MTT and no relevant colouring potential after mixture with aqua dest. and with isopropanol. Therefore, no additional controls for correction of possible false-negative results were necessary.
The test item showed no irritant effects. The mean relative tissue viability (% negative control) was > 50% (111.9%) after 60 min treatment and 42 h post-incubation.
In this study under the given conditions the test item showed no irritant effects. The relative mean tissue viability after 60 min of exposure and 42 h post-incubation was > 50%. The test item is therefore classified as “non-irritant” in accordance with UN GHS “No Category”.
Referenceopen allclose all
* Blank-corrected mean OD570of the negative control corresponds to 100% absolute tissue viability.
** Mean relative tissue viability of the three positive control tissues is < 20%.
*** Standard deviation (SD) obtained from the three concurrently tested tissues is≤ 18%.
**** The mean absolute OD570of the negative control is≥ 0.8 and ≤ 2.8.
Name |
Negative Control | Positive Control | Test Item |
||||||
Replicate tissue | 1 2 3 |
1 2 3 | 1 2 3 |
||||||
Absolute OD 570 | 1.795 1.781 1.549 1.548 1.340 1.367 |
0.119 0.129 0.129 0.141 0.137 0.139 |
1.589 1.584 1.796 1.779 1.796 1.920 |
||||||
Mean Absolute OD570 | 1.563**** | 0.133 | 1.744 | ||||||
Mean OD570 of the duplicates (blank corrected) |
1.743 1.504 1.309 |
0.079 0.090 0.093 |
1.541 1.742 1.813 |
||||||
Total Mean OD570 of the three replicate tissues (blank corrected) |
1.518* |
0.087 |
1.699 |
||||||
Mean Relative Tissue Viability [%] |
100.0 |
5.8** |
111.9 |
||||||
SD of Relative Tissue Viability [%]*** |
14.3 |
0.5 |
9.3 |
||||||
CV [% Viabilitie |
14.3 |
8.6 |
8.3 |
||||||
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Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
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
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.
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