Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 876-151-9 | CAS number: 2292123-68-1
- 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 has been tested for skin and eye irritation using in vitro methods.
In an in vitro skin irritation test conducted in accordance with OECD Guideline 439, the mean cell/tissue viability was reported as 95.3%. This indicates that the substance is not a skin irritant under conditions of the test.
In an in vitro eye irritation test conducted in accordance with OECD Guideline 492, the mean cell/tissue viability was reported 91.1%. This indicates that the substance is not an eye irritant under conditions of the test.
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
- 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)
- Version / remarks:
- June 18, 2019
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Justification for test system used:
- Recommended in the test guideline.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: LabCyte EPI-MODEL24 - SIT
- Tissue batch number(s): LCE24-200727-A
- Expiry date: 31 July 2020
- Date of initiation of testing: 29 July 2020
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37°C
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: rinsed 15 times or more with PBS
- Observable damage in the tissue due to washing: None
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 0.5mg/mL per well
- Incubation time: 180 +/- 5 minutes
- Spectrophotometer: FLUOstar Omega, BMG LABTECH
- Wavelength: 570 and 650nm
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability: OD 1.1
- Barrier function: IC50 = 0.27%
- Morphology: Observation of multilayered epidermis with a stratum corneum
NUMBER OF REPLICATE TISSUES: 3 - Control samples:
- yes, concurrent negative control
- Amount/concentration applied:
- Negative control: Distilled water - 25µl
Positive control: 5% w/v SDS solution - 25µl
Test item: neat (triplicate) - 25 mg - Duration of treatment / exposure:
- 15 minutes +/- 3 minutes
- Duration of post-treatment incubation (if applicable):
- 42 +/- 1 hr
- Number of replicates:
- 3
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1
- Value:
- 92.1
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 2
- Value:
- 90.2
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3
- Value:
- 103.4
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Visible damage on test system: no
- Direct-MTT reduction: no
- Colour interference with MTT: no
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes - mean measurement OD was 0.737
- Acceptance criteria met for positive control: yes - mean cell viability was 2.8
- Acceptance criteria met for variability between replicate measurements: yes - SDs of cell viability were, 2.7%, 1.0% and 7.1% - Interpretation of results:
- GHS criteria not met
- Conclusions:
- The mean cell viability of the test item was 95.3% and therefore the substance is not classified as a skin irritant.
Reference
Table 2: Result of skin irritation test
Group | Tissue no. | Measurement value | Cell viabilitya)(%) | SDc) (%) | Category | ||
Mean | Meand) | ||||||
Negative control (Distilled water) | 1 | 0.759 | 0.737 | 103.0 | 100.0 | 2.7 | - |
2 | 0.721 | 97.8 | |||||
3 | 0.731 | 99.2 | |||||
Positive control (5% w/w SDS solution) | 1 | 0.014 | 0.021 | 1.9 | 2.8 | 1.0 | - |
2 | 0.02 | 2.7 | |||||
3 | 0.029 | 3.9 | |||||
Test Itemd) | 1 | 0.679 | 0.702 | 92.1 | 95.3 | 7.1 | Non-irritant |
2 | 0.665 | 90.2 | |||||
3 | 0.762 | 103.4 |
a) Cell viability in the negative control was regarded as 100%
b) The mean cell viability was calculated from mean OD value of each group
c) The SD was calculated from the cell viability (n=3) of each tissue insert
d) The mean OD value was not corrected because the staining ratio was <5%
Table 3: Results of tissue-binding test
Group | Tissue no. | Measurement value | Staining ratiob) (%) | |
Mean | ||||
Negative contol itema) | 1 | 0.000 | 0.0 | - |
2 | 0.000 | |||
Test itema) | 1 | 0.000 | 0.0 | 0.0 |
2 | 0.000 |
a) Medium without MTT was used instead of MTT medium
b) staining ratio ([mean OD value of the test item (without MTT)] - [mean OD value of negative control (without MTT)] / [mean OD value of negative control (with MTT)]) x 100
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
- 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)
- Version / remarks:
- June 18, 2019
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- human
- Details on test animals or tissues and environmental conditions:
- RECONSTRUCTED HUMAN CORNEAL (EIT) TISSUE
- Model used: LabCyte CORNEAL-MODEL24 EIT (model recommended in test method)
- Tissue batch number(s): LCC24-200817-A
- Expiry date: 21 August 2020
- Date of initiation of testing: 19 August 2020
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37°C - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- yes, concurrent no treatment
- Amount / concentration applied:
- Negative control: No treatment
Positive control: Lauric acid - 10 mg
Test item: neat (triplicate) - 10 mg - Duration of treatment / exposure:
- 24 hours
- Duration of post- treatment incubation (in vitro):
- 240 minutes +/- 15 minutes
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: tissue insert is completely submerged three times
(in a beaker with approx. 100mL PBS) for rinsing. Rinsed ten times or more with PBS
- Observable damage in the tissue due to washing: None
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- WST-8 solution*: 200µL per well
- Incubation time: 240 +/- 15 minutes
- Spectrophotometer: FLUOstar Omega, BMG LABTECH
- Wavelength: 450 and 650nm
*WST-8 solution: Cell counting Kit-8 (WST-8: Lot number NG023, DOJINDO Laboratories) diluted with Earle's balanced salt solution (EBSS: Lot number RNBG9914, SIGMA-ALDRICH). WST-8 : EBSS 1 : 10.
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability: OD 1.3
- Barrier function: IC50 = 0.28%
- Morphology: Observation of Corneal model(including at least 3 layers of epithelial cells and a non-keratinized surface)
NUMBER OF REPLICATE TISSUES: 3 - Irritation parameter:
- mean percent tissue viability
- Value:
- 91.1
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- percent tissue viability
- Run / experiment:
- 1
- Value:
- 95.9
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- percent tissue viability
- Run / experiment:
- 2
- Value:
- 95.5
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- percent tissue viability
- Run / experiment:
- 3
- Value:
- 81.1
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Interpretation of results:
- GHS criteria not met
- Remarks:
- The mean cell viability of the test item was 91.1% and therefore the substance is not classified as an eye irritant.
Reference
Table 2: Result of eye irritation test
Group | Tissue no. | Measurement value | Cell viabilityb), c) (%) | SDe) (%) | Category | |||
Corrected valuea) | Mean | Meand) | ||||||
Negative control (non-treatment) | 1 | 1.179 | - | 1.300 | 90.7 | 100.0 | 15.4 | - |
2 | 1.531 | - | 117.8 | |||||
3 | 1.189 | - | 91.5 | |||||
Positive control (Lauric acid) | 1 | -0.004 | - | -0.004 | 0.0 | 0.0 | 0.0 | - |
2 | -0.005 | - | 0.0 | |||||
3 | -0.004 | - | 0.0 | |||||
Test Item | 1 | 1.247 | 1.247 | 1.184 | 95.9 | 91.1 | 0.0 | Non-irritant |
2 | 1.241 | 1.241 | 95.5 | |||||
3 | 1.063 | 1.063 | 81.8 |
a) OD value was corrected by the result of the binding test
Corrected measurement value = [OD value of the test item (with WST-8)] - {[mean OD value of othe test item (without WST-8)] / [mean OD value of negative control (without WST-8)]}
b) Cell viability in the negative control was regarded as 100%
c) If cell viability was <0, the value was considered to 0%
d) the mean cell viability was calculated from mean OD value of each group
e) The SD was calculated from the cell viability (n=3) of each tissue insert
Table 3: Results of tissue-binding test
Group | Tissue no. | Measurement value | |
Mean | |||
Negative contol (no treatment)a) | 1 | -0.045 | -0.045 |
2 | -0.045 | ||
Test itema) | 1 | -0.045 | -0.045 |
2 | -0.045 |
a) EBSS was used instead of WST-8 solution
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 results of the in vitro studies conducted on skin and eye, the cell/tissue viabilities when the substance was tested were greater than the values which warrant classification. The substance does not fulfil the criteria of classification as a skin or eye irritant under the CLP regulation (EC1272/2008, as amended).
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.