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EC number: 229-695-0 | CAS number: 6658-48-6
- 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
Skin irritation:
In Vitro Skin Irritation Test With SILVIAL using A Human Skin Model dated on 2016 and performed accoridng to the OECD guideline No. 439 shows that the SILVIAL is irritant to skin in the test conditions. In vitro Skin Corrosion Test with SILVIAL using a Human Skin Modeldated on 2017 and performed accoridng to the OECD guideline No. 431 shows that the SILVIAL is not corrosive to skin in the test conditions.
Eye Irritation:
Evaluation of the eye Hazard potential of SILVIAL using the bovine Corneal Opacity and Permeability test (BCOP) dated on 2016 and perfomed according to the OECD Guideline No. 437, has determined that the SILVIAL IVIS is < 3, no classification is required for eye irritation or serious eye damage
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:
- 09 May 2016 to 06 June 2016
- 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)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Principles of method if other than guideline:
- Any deviations from standard operating procedures were evaluated and filed in the study file. There were no deviations from standard operating procedures that affected the integrity of the study.
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Name (as stated in the report): Silvial
Batch No.: SC00017272
Expiration date: 23 October 2016 - Test system:
- human skin model
- Remarks:
- EPISKIN Small Model TM
- Source species:
- human
- Cell type:
- other: adult human-derived epidermal keratinocytes which have been seeded on a dermal substitute consisting of a collagen type I matrix coated with type IV collagen.
- Cell source:
- other: EPISKIN Small ModelTM (EPISKIN-SMTM, 0.38 cm2, Batch no.: 16-EKIN-022)
- Source strain:
- other: SkinEthic Laboratories, Lyon, France
- Justification for test system used:
- In the interest of sound science and animal welfare, a sequential testing strategy is recommended to
minimise the need of in vivo testing. One of the validated in vitro skin irritation tests is the EPISKIN test, which is recommended in international guidelines (e.g. OECD and EC). - Vehicle:
- unchanged (no vehicle)
- Details on test system:
- EPISKIN Small ModelTM (EPISKIN-SMTM, 0.38 cm2, Batch no.: 16-EKIN-022)
This model is a three-dimensional human epidermis model, which consists of adult human-derived epidermal keratinocytes which have been seeded on a dermal substitute consisting of a collagen type
I matrix coated with type IV collagen. The keratinocytes were cultured for 13 days, which results in a highly differentiated and stratified epidermis model comprising the main basal, supra basal, spinous and granular layers and a functional stratum corneum. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- The liquid test item was applied undiluted (25 μl) directly on top of the tissue.
- Duration of treatment / exposure:
- 15 ± 0.5 minutes
- Duration of post-treatment incubation (if applicable):
- 42 hours at 37°C.
- Number of replicates:
- The test was performed on a total of 3 tissues per test item together with negative and positive controls.
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- Mean tissue viability (percentage of control)
- Value:
- 26
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Remarks:
- Since the mean relative tissue viability for SILVIAL was below 50% it is considered to be irritant.
- Other effects / acceptance of results:
- The positive control had a mean cell viability after 15 ± 0.5 minutes exposure of 4.5%. The absolute mean OD570 of the negative control tissues was within the laboratory historical control data range. The standard deviation value of the percentage viability of three tissues treated identically was less than 8%, indicating that the test system functioned properly.
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- Finally, it is concluded that this test is valid and that SILVIAL is irritant in the in vitro skin irritation test under the experimental conditions described in this report.
- Executive summary:
In vitro skin irritation test with SILVIAL using a human skin model.
This report describes the ability of SILVIAL to induce skin irritation on a human three dimensional epidermal model (EPISKIN Small model (EPISKIN-SMTM)). The possible skin irritation potential of SILVIAL was tested through topical application for 15 minutes.
The study procedures described in this report were based on the most recent OECD and EC guidelines.
Batch SC00017272 of SILVIAL was a colourless liquid. SILVIAL was applied undiluted (25 μl) directly on top of the skin tissue for 15 ± 0.5 minutes. After a 42 hour post-incubation period, determination of the cytotoxic (irritancy) effect was performed. Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from MTT at the end of the treatment.
SILVIAL did interact with 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyl tetrazolium bromide (MTT).
In addition to the normal procedure, three killed tissues treated with test item and three killed non-treated tissues were used for the cytotoxicity evaluation with MTT. The non-specific reduction of MTT by SILVIAL was -2.6% of the negative control tissues, therefore no correction was needed.
Skin irritation is expressed as the remaining cell viability after exposure to the test item. The relative mean tissue viability obtained after 15 ± 0.5 minutes treatment with SILVIAL compared to the negative control tissues was 26%. Since the mean relative tissue viability for SILVIAL was below 50% after 15 ± 0.5 minutes treatment it is considered to be irritant.
The positive control had a mean cell viability of 4.5% after 15 ± 0.5 minutes exposure. The absolute mean OD570 (optical density at 570 nm) of the negative control tissues was within the laboratory historical control data range. The standard deviation value of the percentage viability of three tissues treated identically was less than 8%, indicating that the test system functioned properly.
Finally, it is concluded that this test is valid and that SILVIAL is irritant in the in vitro skin irritation test under the experimental conditions described in this report.
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 13 Apr 2017 to 14 Apr 2017
- 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)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Name (as stated in the report): Silvial
Batch No.: SC00017272
Expiration date: 13 October 2017 - Test system:
- human skin model
- Remarks:
- EpiDerm Skin Model
- Source species:
- human
- Cell type:
- other: human-derived epidermal keratinocytes which have been cultured to form a multilayered, highly differentiated model of the human epidermis.
- Cell source:
- other: EpiDerm Skin Model (EPI-200, Lot no.: 25761 kit U and V)
- Source strain:
- other: MatTek Corporation, Ashland MA, U.S.A.
- Justification for test system used:
- Recommended test system in international guidelines (OECD and EC).
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- The model consists of normal, human-derived epidermal keratinocytes which have been cultured to form a multilayered, highly differentiated model of the human epidermis. It consists of organized basal, spinous and granular layers, and a multi-layered stratum corneum containing intercellular lamellar lipid layers arranged in patterns analogous to those found in vivo. The EpiDerm tissues (surface 0.6 cm²) were cultured on polycarbonate membranes of 10 mm cell culture inserts.
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- The liquid test item was applied undiluted (50 μl) directly on top of the tissue
- Duration of treatment / exposure:
- Two tissues were used for a 3-minute exposure to SILVIAL and two for a 1-hour exposure.
- Number of replicates:
- The test was performed on a total of 4 tissues per test item together with a negative control and positive control
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- after 1-minute and 3-minute treatment
- Value:
- 103
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: No indication of corrision
- Other effects / acceptance of results:
- The absolute mean OD570 (optical density at 570 nm) of the negative control tissues was within the acceptance limits of OECD 431 (lower acceptance limit ≥0.8 and upper acceptance limit <=2.8) and the laboratory historical control data range . The mean relative tissue viability following the 1-hour exposure to the positive control was 7%.
In the range of 20 - 100% viability the Coefficient of Variation between tissue replicates was < 7%, indicating that the test system functioned properly - Interpretation of results:
- GHS criteria not met
- Conclusions:
- In conclusion, SILVIAL is not corrosive in the in vitro skin corrosion test under the experimental conditions described in this report.
- Executive summary:
The objective of this study was to evaluate SILVIAL for its ability to induce skin corrosion on a human three dimensional epidermal model (EpiDerm (EPI-200)). The possible corrosive potential of SILVIAL was tested through topical application for 3 minutes and 1 hour.
The study procedures described in this report were based on the most recent OECD and EC guidelines.
Batch SC00017272 of the test item was a colourless liquid. The test item was applied undiluted (50 μl) directly on top of the skin tissue.
The positive control had a mean relative tissue viability of 7% after the 1-hour exposure. The absolute mean OD570 (optical density at 570 nm) of the negative control tissues was within the acceptance limits of OECD 431 (lower acceptance limit ≥0.8 and upper acceptance limit <=2.8) and the laboratory historical control data range. In the range of 20 - 100% viability the Coefficient of Variation between tissue replicates was < 7%, indicating that the test system functioned properly.
Because in the skin irritation test a color change was observed by adding MTT-medium it was concluded that SILVIAL did interact with the MTT endpoint.
In addition to the normal 3-minute and 1-hour procedure, two freeze-killed tissues treated with test item and two freeze-killed negative control treated tissues were used for the cytotoxicity evaluation with MTT at each time point. The non-specific reduction of MTT by SILVIAL was 2.6% and 3.4% of the negative control tissues after 3 minutes and 1 hour respectively.
Skin corrosion is expressed as the remaining cell viability after exposure to the test item. The relative mean tissue viability obtained both after 3-minute and 1-hour treatments with SILVIAL compared to the negative control tissues was 103%. Because the mean relative tissue viability for SILVIAL was not below 50% after the 3-minute treatment and not below 15% after the 1-hour treatment SILVIAL is considered to be not corrosive.
In conclusion, SILVIAL is not corrosive in the in vitro skin corrosion test under the experimental conditions described in this report.
Referenceopen allclose all
SILVIAL compared to the negative control tissues. Skin corrosion is expressed as the remaining cell viability after exposure to the test item. The relative mean tissue viability obtained after both the 3-minute and 1-hour treatments with SILVIAL compared to the negative control tissues was 103%. Because the mean relative tissue viability for SILVIAL was not below 50% after 3 minutes treatment and not below 15% after 1 hour treatment SILVIAL is considered to be not corrosive.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 28 April 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- Principles of method if other than guideline:
- There were no deviations from standard operating procedures that affected the integrity of the study.
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Name (as stated in the report): Silvial
Batch No.: SC00017272
Expiration date: 23 October 2016 - Species:
- cattle
- Details on test animals or tissues and environmental conditions:
- Bovine eyes were used as soon as possible after slaughter. They come from young cattle were obtained from the slaughterhouse (Vitelco, 's Hertogenbosch, The Netherlands), where the eyes were excised by a slaughterhouse employee as soon as possible after slaughter. Eyes were collected and transported in physiological saline in a suitable container under cooled conditions.
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- The test item was tested neat.
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- Undiluted Silvial was introduced onto the epithelium of the cornea.
- Duration of treatment / exposure:
- The cornea were incubated in a horizontal position for 10 ± 1 minutes at 32 ± 1°C after the introduction of the test item or control.
- Irritation parameter:
- in vitro irritation score
- Remarks:
- mean in vitro irritancy score
- Run / experiment:
- after 10 minutes of treatement
- Value:
- 0.3
- Negative controls validity:
- valid
- Remarks:
- ranged from 0.7 to 1.1
- Positive controls validity:
- valid
- Remarks:
- ranged from 41 to 55
- Remarks on result:
- no indication of irritation
- Remarks:
- Since SILVIAL induced an IVIS ≤ 3,
- Other effects / acceptance of results:
- The negative control responses for opacity and permeability were less than the upper limits of the laboratory historical range indicating that the negative control did not induce irritancy on the corneas. The mean in vitro irritancy score of the positive control (Ethanol) was 46 and was within two standard deviations of the current historical positive control mean. It was therefore concluded that the test conditions were adequate and that the test system functioned properly.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Since SILVIAL induced an IVIS ≤ 3, no classification is required for eye irritation or serious eye damage.
- Executive summary:
Evaluation of the eye hazard potential of SILVIAL using the Bovine Corneal Opacity and Permeability test (BCOP test).
This report describes the potency of chemicals to induce serious eye damage using isolated bovine corneas. The eye damage of SILVIAL was tested through topical application for 10 minutes.
The study procedures described in this report were based on the most recent OECD guideline.
Batch SC00017272 of SILVIAL was a colourless liquid with a purity of 99.4%. The test item was applied as it is (750 μl) directly on top of the corneas.
The negative control responses for opacity and permeability were less than the upper limits of the laboratory historical range indicating that the negative control did not induce irritancy on the corneas. The mean in vitro irritancy score of the positive control (Ethanol) was 46 and was within two standard deviations of the current historical positive control mean. It was therefore concluded that the test conditions were adequate and that the test system functioned properly.
SILVIAL did not induce ocular irritation through both endpoints, resulting in a mean in vitro irritancy score of 0.3 after 10 minutes of treatment.
Since SILVIAL induced an IVIS ≤ 3, no classification is required for eye irritation or serious eye damage.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
Silvial has shown a skin irritant potential, it needs to be classified Category 2 (irritant) based on CLP classification criteria. In parallel, the Eye irritant potiential was evaluated and demontrates
SILVIAL IVIS is < 3, no classification is required for eye irritation or serious eye damage.
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