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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 265-747-9 | CAS number: 65405-84-7
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 14. - 27.09.2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: According to guideline under GLP
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Principles of method if other than guideline:
- Not relevant
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- α,2,2,6-tetramethylcyclohexene-1-butyraldehyde
- EC Number:
- 265-747-9
- EC Name:
- α,2,2,6-tetramethylcyclohexene-1-butyraldehyde
- Cas Number:
- 65405-84-7
- Molecular formula:
- C14H24O
- IUPAC Name:
- 2-methyl-4-(2,6,6-trimethylcyclohex-2-en-1-yl)butanal
- Details on test material:
- - Name of test material (as cited in study report): Dihydro-C14-aldehyde
- Physical state: liquid
- Storage condition of test material: At room temperature (range of 20 -25 °C), light protected. The container was tightly closed.
Storage under nitrogen.
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: RCC Ltd Laboratory Animal Service CH-4414 Fullinsdorf/ Switzerland
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 16 g - 24 g
- Housing: Individual in Makrolon type2 cages with standard softwood bedding
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: Under test conditions after health examination. Only animals without any visible signs of illness were used for the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 -23 °C,
- Humidity (%): 30 - 70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 10 %, 25 % and 50 % in acetone/olive oil (4/1, v/v)
application volume, 25 µl, was spread over the entire
dorsal surface (0 - 8 mm) of each ear lobe once daily for three consecutive days - No. of animals per dose:
- 4
- Details on study design:
- RANGE FINDING TESTS:
- Irritation: After a single application, no irritation effects were observed at the dosing sites applied up to
the concentration of 50 %. One day after the single topical application, a slight ear erythema
was noted at the local sites dosed at 100 % (undiluted).
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: LLNA
- Criteria used to consider a positive response: A test item is regarded as a sensitizer in the LLNA if the following criteria are fulfilled:
- First, exposure to at least one concentration of the test item resulted in an
incorporation of 3HTdR at least 3-fold or greater than that recorded in control mice, as indicated by the STIMULATION INDEX (S.I.).
- Second, the data are compatible with a conventional dose response, although
allowance must be made (especially at high topical concentrations) for either local toxicity or immunological suppression. - Positive control substance(s):
- not specified
- Statistics:
- The mean values and standard deviations were calculated in the body weight tables.
A statistical analysis was conducted for assessment of the dose-response relationship, and
the EC3 value was calculated according to the equation
EC3 = (a-c) [(3-d)l(b-d)] + c
where EC3 is the estimated concentration of the test item required to produce a 3-fold
increase in draining lymph node cell proliferative activity; (a, b) and (c, d) are respectively the
co-ordinates of the two pair of data lying immediately below and above the S.I. value of 3 on
the local lymph node assay dose response plot.
Results and discussion
- Positive control results:
- Not relevant
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- 1.8
- Test group / Remarks:
- Group 2: 10% test substance (w/v)
- Remarks on result:
- other: Control: 0; 10% (w/v): 1.8; 25% (w/v): 3.5; 50% (w/v): 6.5
- Key result
- Parameter:
- SI
- Value:
- 6.5
- Test group / Remarks:
- Group 4: 50% test substance (w/v)
- Key result
- Parameter:
- SI
- Value:
- 3.5
- Test group / Remarks:
- Group 3; 25% test substance (w/v)
- Parameter:
- EC3
- Value:
- 20.6
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: DPM per Lymph node: Control: 608; 10% (w/v): 1070; 25% (w/v): 2100; 50% (w/v): 3957
Any other information on results incl. tables
No remarks
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Conclusions:
- The estimated concentration of the test item required to produce a SI of 3 is: EC3 = (a-c) [(3-d)l(b-d)] + c = 20.6 % (w/v). For Dihydro-C14-aldehyde a sensitising potential could be concluded.
- Executive summary:
In order to study a possible contact allergenic potential of Dihydro-CICAldehyde, three
groups each of four female mice were treated daily with the test item at concentrations of
10 %, 25 % and 50 % in acetonelolive oil (4/1, v/v) by topical application to the dorsum of
each ear lobe (left and right) for three consecutive days. A control group of four mice was
treated with the vehicle acetonelolive oil (4/1, v/v) only. Five days after the first topical
a lication the mice were injected intravenously into a tail vein with radio-labelled thymidine
(J H)p- methyl thymidine). Approximately five hours after intravenous injection, the mice were
sacrificed, the draining auricular lymph nodes excised and pooled per group. Single cell
suspensions of lymph node cells were prepared from pooled lymph nodes which were
subsequently washed and incubated with trichloroacetic acid overnight. The proliferative
capacity of pooled lymph node cells was determined by the incorporation of 3HTdR-methyl
thymidine measured in a p-scintillation counter.
All treated animals survived the scheduled study period.
No clinical signs were observed in any animals of the control group or Group 2 (10 %). On
the third application day, a slight ear swelling was observed at both dosing sites in all mice of
Group 3 (25 %), persisting for a total of three days. On the second application day, a slight
to moderate ear swelling was observed at both dosing sites in all mice of Group 4 (50 %), in
addition, on the third application day, a slight ear erythema was also noted. The local signs
in all mice of Group 4 (50 %) persisted for the remainder of the in-life phase of the study.
The results obtained (STIMULATION INDEX (S.I.)) are reported in the following table. The
estimated concentration of test item required to produce a S.I. of 3 is referred to as the EC3
value.
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.