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EC number: 202-819-0 | CAS number: 100-10-7
- 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
GLP OECD 437: IVIS=21.7, no preduction possible on eye irritation
GLP OECD 492: viability=3.5 %, irritant to the eye
GLP OECD 439: skin irritation assy was negative
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:
- 2015-04-23 - 2015-06-19
- 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)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Qualifier:
- according to guideline
- Guideline:
- other: Skinethic skin irritation test -42bis Standard operating procedure (SOP) 2009
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Designation: Art. 803057
Synonym: 4-(Dimethylamino)benzaldehyde
Batch: S6886257
CAS-No.: 100-10-7
Assay (GC, area%): 99.6% (a/a)
Appearance: Grey-blue, crystalline powder
Released until: May 31, 2019
Storage: Tightly closed, dark at room temperature (15 to 25°C) - Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- foreskin from a single donor
- Justification for test system used:
- standard model
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- No vehicle used in this study; The test item was applied neat to the tissues.
- Details on test system:
- CELL CULTURE
- Supplier: EpiSkin/SkinEthic Laboratories, Lyon, France)
- Source: human keratinocytes cultured on a polycarbonate filter in conditions which permit their terminal differentiation
- Format: 24 well plate
- Batch: 15-RHE-059
- Expires: May 18, 2015
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment: room temperature
- Temperature of post-treatment incubation: 37°C
REMOVAL OF THE TEST MATERIAL AND CONTROL
After the end of the treatment interval, the residual test item was removed immediately by gently rinsing with a minimum volume of 25 mL DPBS using a pipette. Excess DPBS was removed by gently shaking the inserts and blotting the bottom with blotting paper. - Control samples:
- yes, concurrent negative control
- Amount/concentration applied:
- TEST MATERIAL: 16 mg of solid test material
NEGATIVE CONTROL: 16 µL (Dulbecco`s Phosphate-Buffered Saline)
POSITIVE CONTROL: 16 µL (5% aqueous solution of sodium dodecyl sulfate in deionised water) - Duration of treatment / exposure:
- 42 min (± 1 minute)
- Duration of post-treatment incubation (if applicable):
- 42 hours (± 1 hour)
- Number of replicates:
- 3
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Experiment 1 / Run 1
- Value:
- 95.6
- Vehicle controls validity:
- not applicable
- Remarks:
- The test item was applied neat to the tissues
- 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: none
- Direct-MTT reduction: none
- Colour interference with MTT: none
ACCEPTANCE OF RESULTS:
Acceptability of the Quality Control Data of the Skin Model with Reference to Historical Batch Data:
The negative control OD values were 2.366, 2.297 and 2.516 and, thus, in the range of ≥0.8 and ≤3.0.
Acceptability of the Positive and Negative Control:
After treatment with the negative control (DPBS-buffer) the mean OD was 2.393 (standard deviation: 4.68%) and, thus, higher than the historically established boundary of 1.388.
After treatment with the positive control (5% aqueous solution of sodium dodecyl sulfate) the mean viability value was 1.02% (standard deviation: 10.96%) and, thus, lower than the historically established boundary of 3.51%.
The standard deviation of the negative control and the positive control was ≤18%, respectively.
Test Substance Data Acceptance Criteria:
The standard deviation of the three tissues treated with the test item was 1.13% and, thus, ≤18%.
Therefore, the study fulfilled the validity criteria. - Interpretation of results:
- not irritating
- Remarks:
- UN GHS: No Caterory (according to OECD TG 439)
- Conclusions:
- This study was performed according to GLP and the methods applied are fully compliant with OECD TG 439. The test material was not irritating in this in vitro assay.
- Executive summary:
This study was performed according to GLP and the methods applied are fully compliant with OECD TG 439. The test material was negative in this in vitro assay.
Reference
Group | Time / [min] | Mean OD | Mean Relative viability / [%] |
Negative Control | 42 | 2.393 | 100 |
Positive Control | 42 | 0.024 |
1.02 |
Test Material |
42 |
2.288 |
95.60 |
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:
- May 6, 2015 - July 13, 2015
- 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
- Qualifier:
- according to guideline
- Guideline:
- EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Designation: Art. 803057
Synonym: 4-(Dimethylamino)benzaldehyde
CAS-No.: 100-10-7
Batch: S6886257
Assay (GC, area%): 99.6% (a/a)
Appearance: Grey-blue, crystalline powder
Released until: May 31, 2019
Storage: Tightly closed, dark at room temperature (15 to 25°C)
PREPARATION OF THE TEST MATERIAL
The test item Art. 803057 was prepared as a 20% (w/v) suspension in a 0.9% sodium chloride solution. The stability in the vehicle was not investigated. The test item preparation was administered within <1 hour after preparation. - Vehicle:
- physiological saline
- Controls:
- yes, concurrent vehicle
- yes, concurrent positive control
- Amount / concentration applied:
- TEST MATERIAL: 750 µL (i.e. 150mg/750µL)
NEGATIVE / VEHICLE CONTROL: 750 µL
Designation: 0.9% sodium chloride solution
Supplier: B. Braun Melsungen AG, Germany
Batch: 13445011
Released until: September 2016
POSITIVE CONTROL: 750 µL
Designation: Art. 814223
Synonym: Imidazole
Supplier: Merck KGaA, Germany
Batch: S6746923
Released until: August 31, 2018
Imidazole was dissolved with 0.9% sodium chloride solution to a concentration of 20% (w/v) - 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 / Experiment 1
- Value:
- 21.7
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- not determinable
- Other effects / acceptance of results:
- OTHER EFFECTS:
- Visible damage on test system: No observations (e.g. tissue peeling, residual test chemical, non-uniform opacity patterns) were seen in a visually inspection of the corneas after treatment.
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: After treatment with the negative control (0.9% sodium chloride solution) the calculated IVIS was 0.7 and, thus, within three standard deviations of the current historical mean of the negative control (IVIS: -1.4 – 3.6).
- Acceptance criteria met for positive control: After treatment with the positive control (20% Imidazole) the calculated IVIS was 99.2 and, thus, also within two standard deviations of the current historical mean of the positive control (IVIS 74.7 – 138.6). Therefore, the study fulfilled the validity criteria. - Interpretation of results:
- other: could not be determined
- Conclusions:
- Under the conditions of the present study, the eye hazard potential of the test item Art. 803057 (4-(Dimethylamino)benzaldehyde) cannot be predicted.
- Executive summary:
This study was performed according to GLP and the methods applied are fully compliant with OECD TG 437. Under the conditions of the present study, the eye hazard potential of the test item Art. 803057 (4-(Dimethylamino)benzaldehyde) cannot be predicted.
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 21.11.2016 - 09.03.2017
- 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)
- Specific details on test material used for the study:
- Identification:
Art. 803057 (4-(Dimethylamino)benzaldehyde)
Batch:
S6886257
Purity:
99.6% (GC, area%)
Appearance:
Grey-blue, crystalline powder
Expiry Date:
31 May 2019
Storage Conditions:
At room temperature, protected from light*
Stability in Solvent:
Not relevant - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- 50 mg
- Duration of treatment / exposure:
- 6 h
- Number of animals or in vitro replicates:
- triplicate
- Details on study design:
- According to guideline
- Irritation parameter:
- other: cell viability
- Run / experiment:
- mean value
- Value:
- 3.4
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- In conclusion, it can be stated that in this study and under the experimental conditions reported, Art. 803057 (4-(Dimethylamino)benzaldehyde) possesses an eye irritating potential.
Referenceopen allclose all
Opacity |
Permeability |
IVIS |
||||
per cornea |
per group (mean value) |
SD |
||||
Negative control |
0.9% NaCl Solution |
1.845 |
-0.003 |
1.800 |
0.7 |
1.0 |
0.383 |
0.000 |
0.388 |
||||
-0.064 |
-0.004 |
-0.124 |
||||
Positive control |
20% Imidazole solution |
64.464 |
2.223 |
97.807 |
99.2 |
2.0 |
59.362 |
2.808 |
101.486 |
||||
67.395 |
2.058 |
98.263 |
||||
Test item |
Art. 803057 |
24.942 |
-0.002 |
24.910 |
21.7 |
3.1 |
18.783 |
-0.001 |
18.766 |
||||
21.504 |
-0.005 |
21.427 |
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
Based on the available information it is justified to:
- not classify for skin irritation
- classify according to GHS Cat 2 for eye irritation (1)
References:
1. Kolle SN, Kandárová H, Wareing B, van Ravenzwaay B, Landsiedel R. In-house validation of the EpiOcular(TM) eye irritation test and its combination with the bovine corneal opacity and permeability test for the assessment of ocular irritation. Altern Lab Anim. 2011 Sep;39(4):365–87.
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