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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 620-318-9 | CAS number: 1003049-92-0
- 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
Under the experimental conditions reported, the test item is not irritating to the skin according to OECD 439.
The structural analogue substance caused severe eye damage according to OECD Guideline 437.
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:
- August 24, 2011 - August 26, 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Version / remarks:
- 2009
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- 2010
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Skinethic Skin irritation test -42bis Standard operating procedure (SOP) 2009
- Version / remarks:
- 2009
- 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:
- To reduce animal testing, this alternative in vitro method was used. The human skin RHE-model closely mimics the biochemical and physiological properties of the upper parts of the human skin, i.e the epidermis.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: SkinEthic™ RHE-model
- Tissue batch number(s): 11 022A 0802
- Date of initiation of testing: August 24, 2011
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: room temperature
- Temperature of post-treatment incubation: 37°C
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: minimum volume of 25 mL PBS using a multi pipette
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1 mg/mL
- Incubation time: 3 hours
- Spectrophotometer: spectrophotometer
- Wavelength: 570 nm
NUMBER OF REPLICATE TISSUES:
3
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION:
One experiment in triplicate
PREDICTION MODEL / DECISION CRITERIA
- The test substance is considered to be irritant to skin if the viability after exposure is less than 50% or equal to 50 %.
- The test substance is considered to be non-irritant to skin if the viability after exposure is greater than 50%. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount applied: 16 mg
NEGATIVE CONTROL
- Amount applied: 16 µL
POSITIVE CONTROL
- Amount applied: 16 µL - Duration of treatment / exposure:
- 42 minutes
- Duration of post-treatment incubation (if applicable):
- 42 hours
- Number of replicates:
- 3
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Tissue 1/experiment 1
- Value:
- 1.681
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Tissue 2/experiment 1
- Value:
- 1.79
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Tissue 3/experiment 1
- Value:
- 1.798
- Vehicle controls validity:
- not examined
- 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
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: Yes
- Acceptance criteria met for positive control: Yes
- Acceptance criteria met for variability between replicate measurements: Yes - Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance is to be considered as non-irritating to the skin under the conditions of this experiment.
- Executive summary:
In an in vitro skin irritation model, substance was tested. The applied cellline (RHE (Reconstructed Human Epidermis) is produced by SkinEthic by culturing human adult keratinocytes on a polycarbonate filter in such a quality that a functional stratum corneum is available and thermal differentation takes place. The test was conducted under GLP and according to OECD guideline 439, the EU Method B.46 and the Standard Operating Procedure of SkinEthic's (Skin irritation test -42bis).
Each test is performed in triplicates. 16µl of controls were directly applied to the tissue. Prior 16mg of test substance were applied, 10 µl of water were sprayed to the tissue. After treatment of (treatment time 42minutes at roomtemperature) substances were removed and tissues were incubated for 424 hours.
For testing validity of the Skin model, a positive control (5% sodiumdodecylsulfate in deionized water) and a negative control (PBS buffer) were used.
After topical exposure of test substance, positive control, or negative control cell viability is measured in a MTT assay. In this assay cell viability is measured by conversion of MTT to a formazan salt by a dehydrogenase enzyme.
As the test item has a very high cell viability of (100%) passing the threshold value of 50%, this item is to be considered as non-irritant. The test is valid since the criteria for the positive control (cell viability < 40%; 3,1% in this test) and the negative control (optical density between 1.2 and 2.5; 1.75 in this itest) are met.
Reference
Results
|
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:
- 2015-11-20 to 2015-11-27
- 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 Ocular Corrosives and Severe Irritants)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Vehicle:
- physiological saline
- Controls:
- yes, concurrent vehicle
- yes, concurrent positive control
- Amount / concentration applied:
- 750 µL (i.e. 150mg/750µL) of test item, negative or positive control
- Duration of treatment / exposure:
- 240 minutes
- Number of animals or in vitro replicates:
- in vitro: triplicate design
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- run 1
- Value:
- 113.9
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- run 1
- Value:
- 62.2
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- fluorescein leakage
- Run / experiment:
- run 1
- Value:
- 3.45
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- Under the given experimental conditions the test material the test material has ocular corrosive potential.
- Executive summary:
This study was performed according to GLP and the methods applied are fully compliant with OECD TG 437. The test material was corrosive in this in vitro assay.
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- For this endpoint information from a structural similar compound is available. This study for this similar compound was performed according to GLP and the methods applied are fully compliant with OECD TG 437. See chapter 13 report for a more detailed justification.
- Reason / purpose for cross-reference:
- read-across source
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- run 1
- Value:
- 113.9
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- run 1
- Value:
- 62.2
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- fluorescein leakage
- Run / experiment:
- run 1
- Value:
- 3.45
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
Referenceopen allclose all
Opacity |
Permeability |
IVIS |
||||
per cornea |
per group (mean value) |
SD |
||||
Negative Control |
0.9 % NaCl Solution |
-0.062 |
-0.001 |
-0.082 |
0.8 |
0.9 |
1.816 |
-0.001 | 1.801 |
||||
0.706 |
-0.001 | 0.696 |
||||
Positive Control |
20 % Imidazole solution |
70.793 |
2.142 |
102.928 |
106.6 |
4.1 |
71.315 |
2.303 |
105.860 |
||||
79.270 |
2.119 |
111.060 |
||||
Test material |
20% suspension |
66.507 |
3.447 |
118.217 |
113.9 |
16.4 |
72.337 |
3.699 |
127.827 |
||||
47.660 |
3.206 |
95.780 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irreversible damage)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In vitro skin irritation study
In an in vitro skin irritation model, substance was tested. The applied cell line (RHE (Reconstructed Human Epidermis) is produced by SkinEthic by culturing human adult keratinocytes on a polycarbonate filter in such a quality that a functional stratum corneum is available and thermal differentation takes place. The test was conducted under GLP and according to OECD guideline 439, the EU Method B.46 and the Standard Operating Procedure of SkinEthic's (Skin irritation test -42bis).
Each test is performed in triplicates. 16µl of controls were directly applied to the tissue. Prior 16 mg of test substance were applied, 10 µl of water were sprayed to the tissue. After treatment of (treatment time 42 minutes at room temperature) substances were removed and tissues were incubated for 42 hours.
For testing validity of the Skin model, a positive control (5% sodiumdodecylsulfate in deionized water) and a negative control (PBS buffer) were used.
After topical exposure of test substance, positive control, or negative control cell viability is measured in a MTT assay. In this assay cell viability is measured by conversion of MTT to a formazan salt by a dehydrogenase enzyme.
As the test item has a very high cell viability of (100%) passing the threshold value of 50%, this item is to be considered as non-irritant. The test is valid since the criteria for the positive control (cell viability < 40%; 3,1% in this test) and the negative control (optical density between 1.2 and 2.5; 1.75 in this itest) are met.
In vitro eye irritation study
The objective of the present study was to examine the potential of the structural analogue substance to induce serious eye damage in the BCOP assay. The BCOP assay with isolated fresh bovine corneas is an accepted in vitro model for ocular hazard assessment.
To determine the eye hazard potential the induced opacity and increased
permeability was investigated in isolated bovine corneas after exposure
to the test item as a 20% (w/v) suspension in a 0.9% sodium chloride
solution. As negative control 0.9% sodium chloride solution and as
positive control 20% (w/v) Imidazole was used. Three corneas were used
per group (negative control, positive control or test item group).
After a first opacity measurement of the untreated bovine corneas, 750
µL of the suspended test item, positive or negative control were applied
on the corneas and incubated for 240 minutes. After the incubation phase
the test item, the positive, and the negative control were rinsed from
the corneas and the opacity was measured again. After the opacity
measurements, the permeability of the corneas was determined by
application of a fluorescein solution for 90 minutes. The amount of
fluorescein solution that crossed the cornea was measured
spectrophotometrically. The opacity and permeability assessments were
combined to determine an In Vitro Irritancy Score (IVIS).
After treatment with the negative control (0.9% sodium chloride solution) the calculated IVIS was 0.1 (study acceptance criteria range: -1.4 – 3.4). Treatment with the positive control (20% Imidazole) revealed an IVIS of 111.2 (study acceptance criteria range: 77.4 – 136.3). Therefore, the study fulfilled the validity criteria. The IVIS obtained after treatment with the test item was 113.9 and, thus, higher than 55.
Under the conditions of the present study, the test item induces serious eye damage in this in vitro assay.
Justification for classification or non-classification
Based on the data provided, the test item is not classified for skin irritation according to Regulation (EC) No 1272/2008. However, based on the results obtained from the structural analogue substance the test item is classified for severe eye damage cat. 1 and labelled with H318 according to Regulation (EC) No 1272/2008.
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.