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EC number: - | 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
Endpoint summary
Administrative data
Description of key information
In an in vitro skin corrosion human skin model test (EpiDerm) according to OECD guideline 431 and in compliance with GLP, mean cell viability was 94.517% after 3 minutes of exposure adn 102.625% after 1 hour of exposure. Therefore, the test item should not be classified as corrosive.
In an in vitro skin corrosion human skin model test (EpiDerm) according to OECD guildeline 439 and in compliance with GLP, the mean relative tissue viability for the substance was below 50%, the substance is therefore considered to be irritant.
The test item had an MQS score of 47.4 and according to OECD guideline 496 is predicted to be classified as UN GHS Category 1.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 14 December 2021 - 05 May 2022
- Reliability:
- 1 (reliable without restriction)
- 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)
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: Adult donors
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- The reconstructed human epidermal model EpiDerm™ (EPl-200-MatTek Corporation) consists of normal human-derived epidermal keratinocytes which have been cultured to form a multi-layered highly differentiated model of the human epidermis. It consists of organised 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.
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- 30µL
- Duration of treatment / exposure:
- 1 hour
- Duration of post-treatment incubation (if applicable):
- 42 hours
- Number of replicates:
- 3 of each, negative control, positive control, and test item
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1 hour
- Value:
- 9.549
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Interpretation of results:
- other: Irritant to the skin
- Conclusions:
- The relative mean tissue viability obtained after a 1 hour treatment with the substance compared to the negative control tissues was 9.549%. Since the mean relative tissue viability for the substance was below 50%, the substance is considered to be irritant.
- Executive summary:
In an in vitro skin corrosion human skin model test (EpiDerm) according to OECD guildeline 439 and in compliance with GLP, the mean relative tissue viability for the substance was below 50%, the substance is therefore considered to be irritant.
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 11 October 2022 - 22 November 2022
- Reliability:
- 1 (reliable without restriction)
- 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)
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: Adult donors
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- The reconstructed human epidermal model Epiderm™ (EPl-200 MatTek Corporation) consists of normal human-derived epidermal keratinocytes which have been cultured to form a multi-layered highly differential model of the human epidermis. It consists of organised 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.
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Duration of treatment / exposure:
- 3 minutes and 1 hour
- Number of replicates:
- 3 of each, negative control, positive control and test item
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1 hour
- Value:
- 102.625
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 minutes
- Value:
- 94.517
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Interpretation of results:
- other: non-corrosive according to Regulation (EC) No 1272/2008
- Conclusions:
- The test item was evaluated for skin corrosion using the EpiDerm tissue model following OECD TG 431 and was found to be non-corrosive.
- Executive summary:
In an in vitro skin corrosion human skin model test (EpiDerm) according to OECD guideline 431 and in compliance with GLP, mean cell viability was 94.517% after 3 minutes of exposure adn 102.625% after 1 hour of exposure. Therefore, the test item should not be classified as corrosive.
Referenceopen allclose all
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:
- supporting study
- Study period:
- 14 October 2022 - 20 December 2022
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 491 (Short Time Exposure In Vitro Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- human
- Vehicle:
- physiological saline
- Controls:
- yes, concurrent vehicle
- yes, concurrent positive control
- Amount / concentration applied:
- 200 µL per well of 1) 5% and 0.05% test item 2) 0.01% positive control 3) saline (vehicle/solvent)
- Duration of treatment / exposure:
- 5 minutes
- Duration of post- treatment incubation (in vitro):
- 2 hours of incubation with MTT, 1 hour of shaking.
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- Three definitive assays were performed for the test article at two concentrations of 5% and 0.05%. The positive control (0.01 % Sodium Lauryl Sulfate (SLS) prepared in saline), the procedural control (Growth Medium), and the solvent control (saline), were tested concurrently. Each treatment group was exposed in triplicate wells containing a confluent monolayer of SIRC cells. After the 5-minute exposures, the treatments were removed, the wells were rinsed, and then a 0.5 mg/mL MTT solution was added to the test wells to assess relative viability. The relative viabilities of the positive control and test article were determined using the saline solvent control.
- Irritation parameter:
- percent tissue viability
- Run / experiment:
- 0.05%, 5 minutes
- Value:
- 1.5
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- percent tissue viability
- Run / experiment:
- 5%, 5 minutes
- Value:
- 104
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Interpretation of results:
- other: Did not fall into category 1 or no category. No standalone prediction can be made.
- Conclusions:
- No standalone prediction can be made, since cell viability was ≤ 70% at a 5% concentration and > 70% at 0.05% concentration.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irreversible damage)
Additional information
Justification for classification or non-classification
Based on the positive result in the skin irritation test and the negative result with the skin corrosion test, the test substance needs to be classified as a skin irritant (bottom up approach). Based on the positive result in the eye irritation/corrosion test, the substance needs to be classified as causing serious eye damage. According to EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008 and GHS this results in skin irritation category 2, H315: Causes skin irritation and serious eye damage category 1, H318: Causes serious eye damage.
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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