Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 219-194-5 | CAS number: 2385-77-5
- 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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Remarks:
- The test substance (Citronellal; CAS 106-23-0) represents the racemate of the registered substance (R)-3,7-dimethyloct-6-enal (CAS 2385-77-5).
- Adequacy of study:
- weight of evidence
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study according to guideline, GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
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:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Citronellal
- EC Number:
- 203-376-6
- EC Name:
- Citronellal
- Cas Number:
- 106-23-0
- Molecular formula:
- C10H18O
- IUPAC Name:
- 3,7-dimethyloct-6-enal
- Details on test material:
- - Name of test material (as cited in study report): citronellal FH
- Physical state: liquid
- Analytical purity: 98.7 %
- Lot/batch No.: 602790
- Storage condition of test material: room temperature and protected from light
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Jackson Laboratories, Bar Harbor, ME
- Age at study initiation: 11 weeks
- Weight at study initiation: 18-25 g
- Fasting period before study: none
- Housing: 5 animals per cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.1-26.7°C
- Humidity (%): 30-53%
- Photoperiod (hrs dark / hrs light): 12/12 hours
Study design: in vivo (LLNA)
- Vehicle:
- other: diethyl phthalate/ethanol in a ratio of 3:1
- Concentration:
- 7.5%, 15%, or 30% (v/v) with the vehicle; test concentrations chosen as typical concentrations in fragrances
- No. of animals per dose:
- 5
- Details on study design:
- MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Criteria used to consider a positive response: The criterion for a positive response is that one or more concentrations of a test material elicits a 3-fold or greater increase in incorporation of 3H-thymidine relative to the vehicle control.
TREATMENT PREPARATION AND ADMINISTRATION: 25 µl administered topically to the dorsum of each ear lobe (left and right) once per day for three consecutive days. Three days after the third topical application (Day 6) all mice were injected intravenously into a tail vein with 250 µl of sterile saline containing approximately 20 µCi [3]H-thymidine. Five hours after the intravenous injection, the animals were sacrificed. Ear thickness measurements of each mouse were recorded and the draining auricular lymph nodes removed. 3H-thymidine incorporation was measured in single cell suspensions of lymph node cells.
Clinical observations: daily, and prior and after application of test substance
Body weight: day 1 and day 6 - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- The evaluation of the equality of means for the DPM, body weight and ear thickness data was made by a one-way analysis of variance using the F distribution to assess statistical significance. If statistically significant differences between the means were found, a Dunnett's test was used to determine the degree of significance from the control means
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: 7.5, 15, 30 % citronellal: SI = 1.28, 1.57, 1.50 positive control (35% hexylcinnamaldehyde): SI=6.27
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: 7.5, 15, and 30% citronellal: 226, 277, 264 vehicle control: 176 positive control: 1103
Any other information on results incl. tables
Table: Measurements of ear thickness
Test group |
Concentration |
Ear thickness (mm) |
Vehicle control |
0.315 |
|
Citronellal |
7.5 % |
0.317 |
15 % |
0.314 |
|
30 % |
0.311 |
|
Positive control |
0.347 * |
* significant increase compared to vehicle control, p<0.001
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.