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Diss Factsheets
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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
The substance was not irritant to the skin ad eye in vitro.
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:
- From February 2022 to March 2022
- 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:
- Batch No.: OP.1501019
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- foreskin from multiple donors
- Justification for test system used:
- It was decided to use this model as it is cited among the suitable kits both by the OECD 439: 2021 and by Reg. CE 440/2008 Annex Part B, B .46. Furthermore, the test proposed by MatTek was validated in 2007 in an international validation study involving BASF SE (Ludwigshafen, Germany), IIVS Inc. (Gaithersburg, USA) ZEBET at BfR (Berlin, Germany) and Zet-LSL (Linz , Austria)
- Details on test system:
- The EpiDermTM model was used which involves corneal epithelium tissue.
The kit used for the test belongs to lot #36122, derived from the keratinocyte strain 00267. In the certificate sent by the supplier, it is stated that no HIV-1, hepatitis B and hepatitis C viruses were found in the batch. Furthermore, no bacteria, yeasts or other fungi were detected.
In the lot quality certificate, the supplier reported that the functionality of the cellular barrier of the lot has passed all the required checks. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- Amount of sample tested in three replicates: Rep1 = 25.7 mg, Rep 2 = 24.8 mg, Rep 3 = 25.1 mg.
- Duration of treatment / exposure:
- Tissues were topically exposed to the sample for 1 hour.
- Duration of post-treatment incubation (if applicable):
- After exposure fresh medium was added and tissues were incubated at 37 °C and 5% CO2 for 24h. The medium was replaced with fresh one for 18h incubation. Then, tissues were transferred to MTT medium and incubated at the same conditions. After 3 hours, tissues were washed with DPBS and blotted.
- Number of replicates:
- 3 replicates were tested
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- The result is an average of three measurements derived by three replicates.
- Value:
- ca. 52.5
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under test conditions, the test item was not irritant to skin.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not 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:
- From February 2022 to March 2022
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Batch No.: OP.1501019
- Species:
- human
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- Amount of sample tested in two replicates: Rep 1 = 50.3 mg, Rep.2 = 50.9 mg
- Duration of treatment / exposure:
- Tissues were exposed for 6 hours to the raw substance by direct contact.
- Duration of post- treatment incubation (in vitro):
- The exposure is followed by washing with DPBS and an 18-hour post-incubation. and an incubation with MTT medium for 3 hours.
- Number of animals or in vitro replicates:
- Two replicates were tested
- Details on study design:
- In vitro "EpiOcular Eye Irritation Test" was used:
the tissues are conditioned by pre-incubation (1 hour or overnight) to release compounds related to transport stress and debris. Then they undergo a further pre-incubation phase for 18 hours. After the pre-incubation phase, the tissues are transferred to a fresh culture medium and exposed for 6 hours to the raw substance by direct contact. The exposure is followed by washing with DPBS and an 18-hour post-incubation. Two tissues are used respectively for the sample, for the negative control (C-) and for the positive control (C+). After exposure, the tissues are rinsed and dried, the test medium is replaced with the MTT medium. After 3 hours of incubation, the tissues are washed with DPBS and dried, then the blue formazan salts are extracted with isopropanol. The optical density (OD) of the formazan extract is determined by a spectrophotometer set at λ = 570 nm and the cell viability is calculated for each tissue as the percentage of the mean of the negative control tissues. The potential eye irritation caused by the test substance is determined according to the residual cell viability obtained after exposure. - Irritation parameter:
- percent tissue viability
- Run / experiment:
- The result is an average of two measurements derived by two replicates.
- Value:
- ca. 94.9
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under test conditions, the test item was not irritant to eyes.
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
Based on the study available, the substance has not to be classified under CLP regulation.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.