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EC number: 620-249-4 | CAS number: 39075-26-8
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 25 June 2007 to 30 July 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study under GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 3,5-dimethoxy-4-propoxybenzaldehyde
- EC Number:
- 620-249-4
- Cas Number:
- 39075-26-8
- Molecular formula:
- C12 H16 O4
- IUPAC Name:
- 3,5-dimethoxy-4-propoxybenzaldehyde
- Test material form:
- other: solid
- Details on test material:
- - Name of test material (as cited in study report): v59442
- Physical state: light yellow brown solid
- Analytical purity: > 94%
- Lot/batch No.: v59442/F2A
- Expiration date of the lot/batch: 01 May 2008
- Storage condition of test material: at room temperature in the dark
- Other: melting at room temperature
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River France, L'Arbresle Cedex France
- Age at study initiation: ca 11 weeks
- Weight at study initiation: 22-28 g
- Housing: individually in Macrolon cages (MI)
- Diet: pelleted rodent diet ad libitum (SM R/M-Z from SSNIFF, Soest, Germany)
- Water: tap water ad libitum
- Acclimation period:> 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.1-23.7°C
- Humidity (%): 39-86%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Remarks:
- based on in-house trials
- Concentration:
- PIT: 100, 50, 25, 10, 5, 2.5 and 1%
Main: 100, 50, 25 and 0% - No. of animals per dose:
- PIT: 2 females/dose
Main 3 females/dose - Details on study design:
- preliminary Irritation Test: treatment on 3 consecutive days, ear was cleaned with tapwater 3-4 hours after application
- Compound solubility: substance container was heated in a water bath to 40 °C for 10 min and formulated less than 4 hours prior to treatment
- Irritation: 1-50% no irritation, 100% very slight erythema
- Lymph node proliferation response: not measured
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: LLNA
- Criteria used to consider a positive response: stimulation index >=3
TREATMENT PREPARATION AND ADMINISTRATION: substance container was heated in a water bath to 40 °C for 10 min and formulated less than 4 hours prior to treatment.
Epidermal induction on the dorsal ear (25 uL) for 3 consecutive days at 0 (vehicle), 25, 50 and 100%. On day 6 injection with radiolabelled thymidine. After ca 5 hours animals were killed, draining lymphnodes were excised, examined visually and pooled per animal in 3 mL PBS. Tissues were processed and radioactivity was assessed using a scintilliation counter. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- not performed
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: see table
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: see table
Any other information on results incl. tables
Concentration (% v/v) in acetone/ olive oil 4:1 |
dpm /group |
Stimulation Index |
Result |
Vehicle |
382 ± 64 |
1.0 |
|
25 |
450 ± 106 |
1.2 ± 0.3 |
Negative |
50 |
518 ± 72 |
1.4 ± 0.3 |
Negative |
100 |
1331 ± 294 |
3.5 ± 1.0 |
Positive |
Mortality/clinical signs: none
Body weight: decreased over the test period (no toxicological significance)
Irritation: slight redness of the ears at the highest concentration.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Conclusions:
- The substance is a skin sentizer and will be classified as H317 (category 1B)
- Executive summary:
In a local lymphnode assay mice (5 females/treatment) received 3 daily applications of the substance at 0, 25, 50 and 100% at the dorsal site of the ear. After injection with radiolabelled thymidine, the SI for the application of the pure substance was 3.5 (mean value). Therefore the substance is considered a skin sensitizer category 1B with a calculated EC3 value of 88%.
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