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EC number: 202-255-5 | CAS number: 93-53-8
- 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
By using different in vitro assays: DPRA, the human cell line activation test (h-CLAT), and KeratinoSens use for skin sensitization testing. The murine local lymph node assay was used as the reference test.
From the above table it was found that theHydratropic aldehyde (93-53-8) found to be sensitizing when used in different In vitro test (Direct protein reactivity assay, (DPRA) Human cell line activation test (h-CLAT),KeratinoSens).
According to the CLP regulations the chemical was classified in category skin sensitization 1.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Data from study report
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- The Hydratropic aldehyde (93-53-8) found to be sensitizing when used in different In vitro test (Direct protein reactivity assay, (DPRA) Human cell line activation test (h-CLAT),KeratinoSens).
- GLP compliance:
- no
- Type of study:
- other: Direct protein reactivity assay (DPRA); Human cell line activation test (h-CLAT); KeratinoSens; Local lymph node assay
- Species:
- human
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals and environmental conditions:
- No data available
- Route:
- other: No data available
- Vehicle:
- other: AOO = Acetone: olive oil (4:1 by volume)
- Concentration / amount:
- No data available
- Route:
- other: No data available
- Vehicle:
- other: AOO = Acetone: olive oil (4:1 by volume)
- Concentration / amount:
- No data available
- No. of animals per dose:
- No data available
- Details on study design:
- No data available
- Challenge controls:
- No data available
- Positive control substance(s):
- not specified
- Positive control results:
- No data available
- Parameter:
- other: Migrated information from in vitro study
- Remarks on result:
- other: Reading: 1st reading. Group: test group. Clinical observations: sensitizing.
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The Hydratropic aldehyde (93-53-8) found to be sensitizing when used in different In vitro test (Direct protein reactivity assay, (DPRA) Human cell line activation test (h-CLAT),KeratinoSens).
- Executive summary:
- By using different
in vitro assays: DPRA, the human cell line activation test (h-CLAT), and
KeratinoSens use for skin sensitization testing. The murine local lymph
node assay was used as the reference test.
From the above table it was found that theHydratropic aldehyde (93-53-8) found to be sensitizing when used in different In vitro test (Direct protein reactivity assay, (DPRA) Human cell line activation test (h-CLAT),KeratinoSens).
According to the CLP regulations the chemical was classified in category skin sensitization 1.
Reference
Not specified
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
The skin sensitization by (W Stokes et al., 2012) of Hydratropaldehyde was assessed in human.By using different in vitro assays: DPRA, the human cell line activation test (h-CLAT), and KeratinoSens use for skin sensitization testing. The murine local lymph node assay was used as the reference test. From the value it was found that the Hydratropic aldehyde (93-53-8) found to be sensitizing when used in different In vitro test (Direct protein reactivity assay, (DPRA) Human cell line activation test (h-CLAT),KeratinoSens). According to the CLP regulations the chemical was classified in category skin sensitization 1.
In a supporting study, the skin sensitization by (National Toxicology Program, 2009)of Hydratropaldehyde was assessed in mouse. Reduced LLNA assay was performed on mouse with different concentrations as 0.5, 1, 2.5, 5, 10 %.From the LLNA study the concentrations used to study were used. Compared to the traditional LLNA, the rLLNA will reduce the number of animals used to assess skin sensitization. In addition to a concurrent vehicle-control group and a positive-control group, the traditional LLNA requires testing four to five mice with each of at least three test-substance dose levels. Because the rLLNA tests only the highest dose level of the test substance being evaluated, in addition to the concurrent control groups, the number of animals tested would be decreased by at least 40% for each test. The vehicle used was acetone: olive oil (4:1). So from the above study it was found that Hydratropic aldehyde (93-53-8) was found to be sensitizing to ear of mouse. According to the CLP regulations the chemical was classified in category skin sensitization 1.
In a supporting study, the skin sensitization by (D.L.J. Opdyke ,1975)of Hydratropaldehyde was assessed in human .Sensitization test was performed on 25 volunteers by maximization test. The chemical tested at a concentration was 2% in petrolatum and found to be non-sensitizing. Therefore, the hydratropic aldehyde (93-53-8) to 25 volunteer was found to be non-sensitizing.
On the basis of available information from majority of target studies , the test substance can be considered as sensitising to the skin, in accordance with the CLP criteria.
Migrated from Short description of key information:
The skin sensitization by (W Stokes et al., 2012) of Hydratropaldehyde was assessed in human.By using different in vitro assays: DPRA, the human cell line activation test (h-CLAT), and KeratinoSens use for skin sensitization testing. The murine local lymph node assay was used as the reference test. From the value it was found that the Hydratropic aldehyde (93-53-8) found to be sensitizing when used in different In vitro test (Direct protein reactivity assay, (DPRA) Human cell line activation test (h-CLAT),KeratinoSens).
Justification for selection of skin sensitisation endpoint:
The skin sensitization by (W Stokes et al., 2012) of Hydratropaldehyde was assessed in human.By using different in vitro assays: DPRA, the human cell line activation test (h-CLAT), and KeratinoSens use for skin sensitization testing. The murine local lymph node assay was used as the reference test. From the value it was found that the Hydratropic aldehyde (93-53-8) found to be sensitizing when used in different In vitro test (Direct protein reactivity assay, (DPRA) Human cell line activation test (h-CLAT),KeratinoSens).The test substanceHydratropaldehyde can be considered assensitising to the skin, can be classified in sin sensitization category 1, in accordance with the CLP criteria.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The test substanceHydratropaldehyde can be considered assensitising to the skin, can be classified in sin sensitization category 1, in accordance with the CLP criteria.
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