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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: - | 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Endpoint summary
Administrative data
Description of key information
The substance was tested for skin irritation in the EpiDermTM model according to OECD 439. 30 uL of the substance, positive control (5% SDS) and negative control (PBS) was applied to the tissue for 60 minutes (25 minutes at room temperature and 35 minutes at 37°C, 5% CO2) and thereafter incubated for 42 hour post-dose at 37°C, 5% CO2. The substance did not interfere by colour or by direct MTT reduction. Tissue viability was 106.9% of negative controls, while validity criteria were evaluated to be met. The substance is concluded to be non-irritant.
The substance was tested for eye irritation in the EpiOcular TM Eye Irritation model according to OECD 492. 50 uL of the substance, positive control (methyl acetate) and negative control (H2O) was applied to the tissue for 30 minutes, followed by a 12 minutes post-treatment immersion at 37°C, 5% CO2 and thereafter incubated for 2 hour post-dose at 37°C, 5% CO2.
The substance did not interfere by colour or by direct MTT reduction. Tissue viability was 100.1% of negative controls, while validity criteria were met. The substance is concluded to be non-irritant.
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:
- 07 December 2017 to 15 December 2017
- 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)
- GLP compliance:
- yes (incl. QA statement)
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- other: reconstructed human skin
- Cell source:
- other: EpiDerm TM (EPI-200-MatTek Corporation)
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDerm TM (EPI-200-MatTek Corporation)
- Tissue batch number(s): (Lot 25864)
- Delivery date: 12 December 2017
- Date of initiation of testing: no data
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 60 minutes (25 minutes at room temperature and 35 minutes at 37°C, 5% CO2)
- Temperature of post-treatment incubation: 42 hour post-dose incubation at 37°C, 5% CO2
REMOVAL OF TEST MATERIAL AND CONTROLS
- Volume and number of washing steps: not indicated (according to MatTEek SOP)
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE: no data (according to MatTEek SOP)
- MTT concentration: not specified
- Incubation time: no data
- Spectrophotometer: not identified measured at 570 nm
- Wavelength: 570 nm
- Filter: none
- Linear OD range of spectrophotometer: no data
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability: yes (1.601 ± 0.007 (mean and SD of MTT value of 3 tissues exposed to H2O) )
- Barrier function: yes (ET 50% of tissues exposed to 100 µL Triton X-100 1% (n=3): 5.84 h)
- Morphology: yes ( Histological examination demonstrates human epidermis-like structure: including multiple layers (at least 4) of viable epithelial cells (basal layer, stratum spinosum, stratum granulosum) which are present under multilayered stratum corneum ; Tissue thickness: 128 µm )
- Contamination: No contamination reported
- Reproducibility: yes (The mean OD of the 6 wells containing extraction solvent alone (blanks) should be ≤ 0.1., but was 0.149 evaluated not to have affected the measurements, based upon historical system data for blanks; < 0.244) - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 30 µl
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 30 µl PBS
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 30 µl SDS
- Concentration (if solution): 5% in water - Duration of treatment / exposure:
- 60 minutes (25 minutes at room temperature and 35 minutes at 37°C, 5% CO2)
- Duration of post-treatment incubation (if applicable):
- 42 hour post-dose incubation at 37°C, 5% CO2
- Number of replicates:
- 3/treatment
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- 106.9
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks:
- mean viability 4.5%
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- No colour interference or interference with MTT reduction as tested in a pre-test
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance is non-irritant in the EpiDermTM model
- Executive summary:
The substance was tested for skin irritation in the EpiDermTM model according to OECD 439. 30 uL of the substance, positive control (5% SDS) and negative control (PBS) was applied to the tissue for 60 minutes (25 minutes at room temperature and 35 minutes at 37°C, 5% CO2) and thereafter incubated for 42 hour post-dose at 37°C, 5% CO2. The substance did not interfere by colour or by direct MTT reduction. Tissue viability was 106.9% of negative controls, while validity criteria were evaluated to be met. The substance is concluded to be non-irritant.
Reference
Name |
Code |
Mean of OD |
SD of OD |
Mean of viability (%) |
SD of viability (%) |
CV % |
Classification |
DPBS |
NC |
1.768 |
0.210 |
100.000 |
11.904 |
11.904 |
Non-Irritant |
SDS 5% |
PC |
0.080 |
0.016 |
4.535 |
0.909 |
20.046 |
Irritant |
Substance |
TA2 |
1.889 |
0.142 |
106.873 |
8.008 |
7.493 |
Non-Irritant |
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:
- 05 December 2017 to 14 December 2017
- 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)
- GLP compliance:
- yes (incl. QA statement)
- Species:
- human
- Details on test animals or tissues and environmental conditions:
- - Tissue :Reconstructed human Cornea-like Epithelium (RhCE)
- Model used: ‘EpiOcularTM irritation test ( MatTek Corporation EpiOcularTM EIT (OCL-200) Reconstituted Human Ocular Epithelium )
- Tissue batch number(s): (Lot # 27017)
- Delivery date: 12 December 2017
- Date of initiation of testing: no data
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 30 minutes ± 2 minutes, followed by a 12 ± 2 minutes’ post-treatment immersion at 37°C, 5% CO2
- Temperature of post-treatment incubation: 2 hours ± 15 minutes’ post-treatment incubation at 37°C, 5% CO2
REMOVAL OF TEST MATERIAL AND CONTROLS
- Volume and number of washing steps: not indicated (according to MatTEek SOP)
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE: no data (according to MatTek SOP)
- MTT concentration: not specified
- Incubation time: no data
- Spectrophotometer: not identified measured at 570 nm - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- yes, concurrent positive control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 µl - Duration of treatment / exposure:
- 30 minutes ± 2 minutes, followed by a 12 ± 2 minutes’ post-treatment immersion at 37°C, 5% CO2
- Number of animals or in vitro replicates:
- 3 replicates
- Details on study design:
- tisues were wetted with 20 uL PBS before application of the substance or controls
negative control: sterile H2O
positive control: methyl acetate (neat)
number of replicates: 3 - Irritation parameter:
- other: viability (%)
- Value:
- 100.1
- Negative controls validity:
- valid
- Remarks:
- OD570 1.992
- Positive controls validity:
- valid
- Remarks:
- viability 40.03%
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- Acceptance criteria passed
Acceptance criterion 1 The mean OD570 of the negative control(treated with PBS) tissues is > 0.8 and < 2.8
Acceptance criterion 2 The mean of the positive control relative percentage viability must be below 50% of the mean of the negative controls.
Acceptance criterion 3 The standard deviationof OD values between three replicates in each experimental condition must be ≤ 18%
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance is not irritant when tested in the EpiOcular TM Eye Irritation Test
- Executive summary:
The substance was tested for eye irritation in the EpiOcular TM Eye Irritation model according to OECD 492. 50 uL of the substance, positive control (methyl acetate) and negative control (H2O) was applied to the tissue for 30 minutes, followed by a 12 minutes post-treatment immersion at 37°C, 5% CO2 and thereafter incubated for 2 hour post-dose at 37°C, 5% CO2.
The substance did not interfere by colour or by direct MTT reduction. Tissue viability was 100.1% of negative controls, while validity criteria were met. The substance is concluded to be non-irritant.
Reference
Name |
Code |
mean of OD |
SD of OD |
Mean of viability (%) |
SD of viability (%) |
CV % |
Classification |
Sterile water |
NC |
1.992 |
0.094 |
100.000 |
4.74 |
4.738 |
Non-Irritant |
Methyl Acetate |
PC |
0.797 |
0.139 |
40.030 |
6.966 |
17.401 |
Irritant |
Substance |
TA1 |
1.994 |
0.049 |
100.100 |
2.467 |
2.465 |
No Category |
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 information available the substance does not need to be classified for skin- and eye irritation according to EC Regulation 1272/2008 (CLP).
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.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)