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EC number: 941-637-2 | CAS number: 1384257-92-4
- 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 did not show a skin irritating potential in an in vitro skin irritation test using a reconstructed human skin model.
The eye irritating potential of the substance was investigated in two in vitro tests, i.e. a BCOP and an ICE test. No corrosive or severe irritating effects have been observed in the BCOP test. From the ICE test, it is concluded that the substance is irritating to the eyes (Category 2, sub-category 2B).
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:
- 2013-03-18 to 2013-07-25
- 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
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: SOP SkinEthic Skin Irritation Test-42bis
- 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:
- The human skin RHE model has been validated for this type of study.
- Vehicle:
- unchanged (no vehicle)
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 16 µL
NEGATIVE CONTROL
- PBS buffer
- Amount(s) applied (volume or weight): 16 µL
POSITIVE CONTROL
- Sodium dodecyl sulfate
- Amount(s) applied (volume or weight): 16 µL
- Concentration (if solution): 5% - Duration of treatment / exposure:
- 42 minutes
- Duration of post-treatment incubation (if applicable):
- not applicable
- Number of replicates:
- 3 membranes for each group (test item, negative control and positive control)
- Species:
- other: Reconstructed human epidermis model
- Details on test animals or test system and environmental conditions:
- Reconstructed human epidermis model (RHE)
Supplier: SkinEthic
Test System: Human keratinocytes on a polycarbonate filter inserted in a sealed 24-well plate
Tissue Batch: 13 022A 0308
The tissue batch used fully met the quality and validity criteria as described in OECD TG 439 - Type of coverage:
- open
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 16 µL
- Duration of treatment / exposure:
- 42 minutes (according to the suppliers protocol)
- Number of animals:
- The test item, the positive and the negative control were tested in batch-triplicates, i.e. 9 tissues were used for this study
- Details on study design:
- The study was performed according to OECD TG 439, Council Regulation (EC) No. 761/2009, Method B.46 and the SOP SkinEthic Skin Irritation Test-42bis (2009)
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- 90.33
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Visible damage on test system: no
- Direct-MTT reduction: no
- Colour interference with MTT: no
DEMONSTRATION OF TECHNICAL PROFICIENCY:
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes (mean OD = 2.183 at 570 nm)
- Acceptance criteria met for positive control: Yes (mean relative viability = 1.00%)
- Acceptance criteria met for variability between replicate measurements: yes (standard deviation values < 18%) - Irritant / corrosive response data:
- not applicable
- Other effects:
- not applicable
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- Under the experimental conditions reported, the test item is not irritating to the skin.
- Executive summary:
see above
Reference
This in vitro study was performed to
assess the irritating potential of the test item by means of the Human
Skin Model Test. The test item was applied topically to a human
reconstructed skin model followed by a cell viability test. Cell
viability was measured by dehydrogenase conversion of MTT into a blue
formazan salt, which was quantitatively measured after extraction from
tissues. The percent reduction of cell viability in comparison to
untreated negative controls was used to predict skin irritation.
Triplicates of the human skin model RHETMwere treated with 16
µL of the test item, the negative (PBS buffer) or the positive control
(5% aqueous dodecyl sulphate solution) for 42 minutes, respectively.
Treatment with the positive control
induced a sufficient decrease in the relative absorbance as compared to
the negative control for the treatment interval thus ensuring the
validity of the test system. After treatment with the negative control
the absorbance values reached the required acceptability criterion of an
optical density (OD) >/=1.2
and </=2.5 for the treatment
interval thus showing the quality of the tissues.
The mean relative tissue viability after treatment with the test item
was 90.33% and, thus, higher than 50.0%. Therefore, the test item is
considered to possess no irritating potential to the skin.
Under the experimental conditions reported, the test item is not irritating to the skin.
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:
- 2014-12-10 to 2015-02-12
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- GLP
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 438 (Isolated Chicken Eye Test Method for Identifying Ocular Corrosives and Severe Irritants)
- Deviations:
- yes
- Remarks:
- Histopathology included
- Qualifier:
- according to guideline
- Guideline:
- EU method B.48 (Isolated chicken eye test method for identifying occular corrosives and severe irritants)
- Deviations:
- yes
- Remarks:
- histopathology included
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Lot/batch No.of test material: DRZ22129-058
- Expiration date of the lot/batch: 2015-06-04
- Purity test date: 2014-06-04
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: controlled room temperature (15-25°C), below 70% RH
- Stability under test conditions: yes - Species:
- other: Isolated chicken eyes
- Strain:
- other: COBB 500
- Details on test animals or tissues and environmental conditions:
- Source of chicken eyes: Chicken eyes were isolated from chicken heads, which were obtained from a slaughter house
Strain of chicken: COBB 500 - Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- 30 µL of the test item was applied onto the entire surface of the cornea
- Duration of treatment / exposure:
- The eyes were rinsed with 20 mL physiological saline after an exposure period of 10 seconds from the end of application.
- Number of animals or in vitro replicates:
- Number of test material treated eyes: 3
Number of positive control treated eyes: 3
Number of negative control eye: 1 - Details on study design:
- The eye irritating potential of the test item was investigated in isolated chicken's eyes. The test was performed according to OECD TG No. 438.
- Irritation parameter:
- percent corneal swelling
- Remarks:
- at up to 75 min [%]
- Value:
- 3.2
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- percent corneal swelling
- Remarks:
- at up to 240 min [%]
- Value:
- 6.9
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- cornea opacity score
- Value:
- 0.5
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- fluorescein retention score
- Value:
- 1.67
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Interpretation of results:
- Category 2B (mildly irritating to eyes) based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- Based on th eresults of this test, the test item should be classified as irritating to the eyes and categorized as Category 2 (sub-category 2B).
- Executive summary:
see above
Reference
An in vitro eye irritation study of the test item was performed in isolated chicken’s eyes. The irritation effects of the test item were evaluated according to the OECD No.: 438 (26th July 2013). After the zero reference measurements, the eye was held in horizontal position and 30 µL of the liquid test item was applied onto the centre of the cornea such that the entire surface of the cornea was covered. After 10 seconds, the surface was rinsed with saline. The positive control eyes were treated with 30 µL of 5% (w/v) Benzalkonium chloride solution. The negative control eye was treated with 30 µL of physiological saline (Salsol solution, NaCl 0.9% w/v). Based on this in vitro eye irritation in the isolated chicken eyes test, the test item is not classified as a severe irritant and not classified as non-irritant. To further establish the classification, histopathological observations were made on two sections of each of the 3 corneas treated with test item (6 sections). Microscopic evaluation showed very slight erosion of the corneal epithelium (6/6). No stromal and endothelial changes were observed as well as no effects on integrity of basement, Bowman’s and Descemet’s membranes. Thus, the test item was categorized as Category 2 (sub-category 2B). Taking a weight of evidence approach, the overall results were categorized as Category 2 (sub-category 2B).
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
The substance must not be classified as a skin irritant.
Based on the results of two in vitro eye irritation tests (BCOP, ICE), the substance should be classified as irritating to the eyes (Category 2).
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