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EC number: 203-116-1 | CAS number: 103-48-0
- 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
Skin: The test substance was shown to be not irritating to skin.
Eyes: The test substance was found to be non-irritating to the eyes.
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:
- 2015-06-12 to 2015-12-15
- 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:
- 2013
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Version / remarks:
- 2009
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test system:
- human skin model
- Cell type:
- non-transformed keratinocytes
- Details on animal used as source of test system:
- Epi-200 SIT kits and MTT-100 assays diluent were purchased from MatTek Corporation (82105 Bratislava, Slovakia). EpiDerm™ tissues were shipped with cool packs on medium-supplemented agarose gels in a 24-well plate. On day of receipt the pre-incubation phase of the EpiDerm™ tissues started.
- Justification for test system used:
- The EpiDerm TM is an in vitro system recommended by the corresponding guideline.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: Epi-200-SIT Kit
- Tissue batch number: 21678
- Date of initiation of testing: 2015-06-12
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37 °C for 35 minutes; room temperature for 25 minutes
- Temperature of post-treatment incubation: 37 °C
REMOVAL OF TEST MATERIAL AND CONTROLS
- Volume and number of washing steps: rinsing for 15 min, submerging in DPBS at least 3 times
- Observable damage in the tissue due to washing: none
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1mg/mL
- Incubation time: 3 h
- Spectrophotometer: Versamax Molecular Devices, Softmax Pro
- Wavelength: 570 nm
- Filter: +/- 1 nm
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability: 1.976 +/- 0.049 passed
- Barrier function: 6.44 hrs; passed
- Contamination: sterile; passed
NUMBER OF REPLICATE TISSUES: 3
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: 1
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test substance is considered to be irritant to skin if the viability after 60 minutes exposure and 42 h post exposure is less than or equal to 50% of the negative control
- The test substance is considered to be non-irritant to skin if the viability after 60 minutes exposure and 42 h post exposure is greater than 50% of the negative control - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount applied: 30 µL
NEGATIVE CONTROL
- Amount applied: 30 µL
POSITIVE CONTROL
- Amount applied: 30 µL
- Concentration: 5 % solution - Duration of treatment / exposure:
- 60 min
- Duration of post-treatment incubation (if applicable):
- 42 h and 5 min
- Number of replicates:
- 3
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- test item
- Value:
- 103.7
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- positive control
- Value:
- 6.5
- 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: none
- Direct-MTT reduction: none
- Colour interference with MTT: none
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 item is not considered to be irritant to skin.
- Executive summary:
This in vitro study was performed to assess the irritation potential of the test item by means of the Human Skin Model Test. Each three tissues of the human skin model EpiDerm™ were treated with the test item, the negative or the positive control for 60 minutes. 30 μL of the test item were applied to each tissue, and spread to match the surface of the tissue. 30 μL of either the negative control (DPBS) or the positive control (5% SLS) were applied to each tissue. After treatment with the negative control the absorbance values were well in the required range of the acceptability criterion of mean OD ≥ 0.8 and ≤ 2.8 for the 60 minutes treatment interval, thus assuring the quality of the tissues. Treatment with the positive control induced a sufficient decrease in the relative absorbance as compared to the negative control for the 60 minutes treatment interval, and thus assuring the validity of the test system. After treatment with the test item the mean relative absorbance value was increased to 103.7% compared to the relative absorbance value of the negative control. This value is above the threshold for irritancy of ≤ 50%. Therefore, the test item is not considered to possess an irritant potential. In conclusion, it can be stated that in this study and under the experimental conditions reported, the test substance is not irritant to skin.
Reference
Results
Dose Group |
Exposure Interval |
Absorbance 570 nm Tissue 1* |
Absorbance 570 nm Tissue 2* |
Absorbance 570 nm Tissue 3* |
Mean Absorbance of 3 Tissues |
Rel. Absor-bance [%] Tissue 1, 2 + 3**
|
Relative standard deviation [%] |
Rel. Absorbance [% of Negative Control]** |
Negative control |
60 min |
1.417 |
1.382 |
1.413 |
1.404 |
100.9 98.4 100.7 |
1.4 |
100.0 |
Positive control |
60 min |
0.104 |
0.095 |
0.075 |
0.091 |
7.4 6.7 5.4 |
16.2 |
6.5 |
Test item |
60 min |
1.499 |
1.523 |
1.347 |
1.456 |
106.8 108.5 96 |
6.5 |
103.7 |
* Mean of three replicate wells after blank correction
** relative absorbance per tissue [rounded values]: (100x(absorbance tissue))/ mean absorbance negative control
*** relative absorbance per treatment group [rounded values]: (100x(mean absorbance test item/positive control))/ mean absorbance negative control
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2001-02-26 to 2001-02-03
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1997
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- other: Little-russian
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: BI Pharma KG, 88397 Biberach
- Housing: individually in PPO cages (floor area: 2576 sq.cm) with perforated floor
- Diet: ad libitum, pelleted complete rabbit diet "Altromin 2123" from Altromin, 32791 Lage, Germany
- Water: ad libitum, domestic quality drinking water acidified with hydrochloric acid to pH 2.5 in order to prevent microbial growth
- Acclimation period: at least one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 55 +/- 15
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 mL - Duration of treatment / exposure:
- The eyelids were gently held to gether for one second after instillation of the test material. The eyes were not washed out afterwards.
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 4
- Details on study design:
- SCORING SYSTEM:
Draize scoring system
TOOL USED TO ASSESS SCORE: fluorescein - Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- One hour after application of the test article all four animals showed slight symptoms (conjunctiva redness and chemosis were scored 1). After 24 hours one animal exhibited a conjunctiva with some vessels definitely injected. All animals were free of symptoms after 48 hours.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test material was not irritating to the rabbits' eyes.
- Executive summary:
An acute eye irritation study was conducted on 4 rabbits. 0.1 mL of the test material were therefore instilled in one eye, the other eye served as control. Eye reactions were scored 1, 24, 48 and 72 hours after treatment. The study was initiated with one rabbit. Since no marked eye irritation was seen in this animal another three rabbits were included in the study. One hour after application of the test article all four animals showed slight symptoms (conjunctiva redness and chemosis were scored 1). After 24 hours one animal exhibited a conjunctiva with some vessels definitely injected. All animals were free of symptoms after 48 hours. The mean scores (24/48 and 72 hours) were 0 for cornea opacity, iris lesion and oedema and 0.33 for conjunctiva redness. Therefore, the test material was considered to be non-irritating to the eyes.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin:
An in vitro study was performed to assess the irritation potential of the test item by means of the Human Skin Model Test. Each three tissues of the human skin model EpiDerm™ were treated with the test item, the negative or the positive control for 60 minutes. 30 μL of the test item were applied to each tissue. 30 μL of either the negative control (DPBS) or the positive control (5% SLS) were applied to each tissue. Treatment with the positive control induced a sufficient decrease in the relative absorbance as compared to the negative control for the 60 minutes treatment interval, and thus assuring the validity of the test system. After treatment with the test item the mean relative absorbance value was increased to 103.7% compared to the relative absorbance value of the negative control. This value is above the threshold for irritancy of ≤ 50%. Therefore, the test item is not considered to possess an irritant potential.
Eyes:
An acute eye irritation study was conducted on 4 rabbits. 0.1 mL of the test material were therefore instilled in one eye, the other eye served as control. Eye reactions were scored 1, 24, 48 and 72 hours after treatment. The study was initiated with one rabbit. Since no marked eye irritation was seen in this animal another three rabbits were included in the study. One hour after application of the test article all four animals showed slight symptoms (conjunctiva redness and chemosis were scored 1). After 24 hours one animal exhibited a conjunctiva with some vessels definitely injected. All animals were free of symptoms after 48 hours. The mean scores (24/48 and 72 hours) were 0 for cornea opacity, iris lesion and oedema and 0.1 for conjunctiva redness. Therefore, the test material was considered to be non-irritating to the eyes.
Justification for classification or non-classification
Classification,
Labelling, and Packaging Regulation (EC) No 1272/2008
The
available experimental test data are reliable and suitable for
classification purposes under Regulation (EC) No 1272/2008. Based on
available data on skin and eye irritation the
test item is not classified according
to Regulation (EC) No 1272/2008 (CLP), as amended for the eighth time in
Regulation (EU) No 2016/918.
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