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EC number: 627-354-4 | CAS number: 65873-72-5
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 11 September - 13 September, 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 6-methoxypyridine-3-carbaldehyde
- Cas Number:
- 65873-72-5
- Molecular formula:
- C7H7NO2
- IUPAC Name:
- 6-methoxypyridine-3-carbaldehyde
- Test material form:
- solid: particulate/powder
- Details on test material:
- Batch (Lot) Number: 2019-03-29
Physical Description: Cream powder
Storage Conditions: Kept in a controlled room temperature area, protected from light
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- other: human-derived epidermal keratinocytes
- Cell source:
- other: not specified
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- The test article was administered to the test system without dilution. Since the test article was a powder, 25 µL of CMF DPBS was applied to the tissues prior to addition of approximately 25 mg of the test article, which was administered using a dosing spoon. A sterile rod was used to spread the test article over the surface of the tissues.
- Duration of treatment / exposure:
- The test article, LSN2607535 (COM-1074), the positive control [5% Sodium Dodecyl Sulfate (SDS)], and the negative control [Calcium & Magnesium Free Dulbecco’s Phosphate Buffered Saline (CMF DPBS)] were treated in triplicate EpiDermTM tissues for a 60 ± 1 minute exposure period.
- Duration of post-treatment incubation (if applicable):
- There was a 42 ± 2 hour post-exposure incubation period.
- Number of replicates:
- triplicate
Test system
- Details on study design:
- Since the test article was a powder, a mesh was not used for its application onto the EpiDerm™ tissues.
The test article, LSN2607535 (COM-1074) was not observed to directly reduce MTT in the absence of viable cells.
The test article, LSN2607535 (COM-1074) was not considered to have probable photometric MTT interference.
The experimental design of the study consisted of the determination of the direct MTT reduction potential, assessment of colorant potential, a pH determinatin of the neat liquid test article and/or dosing dilution, and a definitive Skin Irritation Test (SIT). On the day of receipt, the EpiDerm(TM) tissues were conditioned by an overnight incubation for release of transport-stress related compounds and debris. After pre-incubation, tissues were topically exposed in triplicate to the test article, positive control, and negative control for 60 minutes. Tissues were then thoroughly rinsed to remove the test or control article, blotted, and transferred to fresh medium. After a 24-hour incubation period, the tissues were re-fed with fresh medium, and incubated for another 18 hours for a total 42-hour post-exposure incubation period. Viability was determined by the NAD(P)H-dependent microsomal enzyme reduction of MTT in control and test article-treated tissues. The MTT assay was performed by transferring the tissues to 24-well plates containing MTT. After a 3 hour MTT incubation, the blue formazan salt formed by cellular mitochonria was extracted with 2 mL isopropanol per tissue and the optical denisty of the extracted formazan was determined with a spectrophotometer at 570 nm. Relative cell viability was calculated for each tissue as % of the mean of the negative control-treated tissues. Skin irritation potential of the test article was predicted if the relative viability was less than or equal to 50%.
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- 31
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Other effects / acceptance of results:
- The mean tissue viability of the positive control was 5%.
Any other information on results incl. tables
The assay was accepted when the following criteria were met: 1) the positive control (5% SDS) resulted in a mean tissue viability ≤ 20%, 2) the mean OD570 value of the negative control tissues was >/= 0.8 and < 2.8, and 3) the standard deviations of the positive and negative control calculated from individual percent tissue viabilities of the three identically treated replicates were < 18%.
Applicant's summary and conclusion
- Interpretation of results:
- other: Self-classified as category 2
- Conclusions:
- According to the prediction model presented in OECD TG 439, the test article was predicted to be an irritant. Additional testing would be needed to determine if the test article was a GHS Category 1 (Severe/Corrosive) or GHS Category 2 (Irritant) for skin irritation.
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