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EC number: 915-617-9 | CAS number: -
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Reaction mass of 3-(4-hydroxy-4-methylpentyl)cyclohex-3-ene-1-carbaldehyde and 4-(4-hydroxy-4-methylpentyl)cyclohex-3-enecarbaldehyde
- EC Number:
- 915-617-9
- Molecular formula:
- C13H22O2
- IUPAC Name:
- Reaction mass of 3-(4-hydroxy-4-methylpentyl)cyclohex-3-ene-1-carbaldehyde and 4-(4-hydroxy-4-methylpentyl)cyclohex-3-enecarbaldehyde
- Test material form:
- liquid
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Remarks:
- CaOlaHsd
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Netherlands
- Age at study initiation: 7 - 12 weeks
- Weight at study initiation: 13.6 - 21.8 g
- Housing: in groups of 4 in Makrolon type-3 cages with standard softwood bedding
- Diet: pelleted standard Kliba 3433 mouse maintenance diet, ad libitum
- Water: community tap water from Itingen, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- 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:
- 1, 2.5, 5, 10 and 25 %
- No. of animals per dose:
- 4 females
- Details on study design:
- MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: LLNA
- Criteria used to consider a positive response: a test item was regarded as a sensitiser if the following criteria were fulfilled:
a) exposure to at least one concentration of the test item resulted in an incorporation of 3-H-methl thymidine at least 3-fold or greater than recorded in control mice, as indicated by the stimulation index;
b) the data are comparable with a conventional dose response, although allowance must be made (especially at high topical concentrations) for either local toxicity or immunological suppression.
TREATMENT PREPARATION AND ADMINISTRATION:
Each group of mice was treated by epidermal topical application to the dorsal surface of each ear lobe (left and right) with different test item concentrations. The mice of the positive control group (alpha-hexylcinnamaldehyde) were treated in the same way at a concentration of 25 %. The application volume of 25 μL was spread over the entire dorsal surface of each ear lobe once daily for three consecutive days. A further group of mice was treated with an equivalent volume of the relevant vehicle alone. A hair dryer was used to dry the ear's surface as quickly as possible to avoid loss of test item applied. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- Mean values and standard deviations were calculated.
Results and discussion
- Positive control results:
- Stimulation index of 7.2 for 25 % solution
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- EC3
- Value:
- 0.171
- Parameter:
- SI
- Value:
- 0.6
- Test group / Remarks:
- 1 % (v/v)
- Remarks on result:
- other: 1%
- Parameter:
- SI
- Value:
- 0.7
- Test group / Remarks:
- 2.5 % (v/v)
- Remarks on result:
- other: 2.5%
- Parameter:
- SI
- Value:
- 0.6
- Test group / Remarks:
- 5 % (v/v)
- Remarks on result:
- other: 5%
- Parameter:
- SI
- Value:
- 1.3
- Test group / Remarks:
- 10 % (v/v)
- Remarks on result:
- other: 10%
- Parameter:
- SI
- Value:
- 4.9
- Test group / Remarks:
- 25 % (v/v)
- Remarks on result:
- other: 25%
- Parameter:
- other: disintegrations per minute (DPM)
- Value:
- 3 960
- Test group / Remarks:
- 1 % (v/v)
- Remarks on result:
- other: 1%
- Parameter:
- other: disintegrations per minute (DPM)
- Value:
- 4 687
- Test group / Remarks:
- 2.5 % (v/v)
- Remarks on result:
- other: 2.5%
- Parameter:
- other: disintegrations per minute (DPM)
- Value:
- 4 063
- Test group / Remarks:
- 5 % (v/v)
- Remarks on result:
- other: 5%
- Parameter:
- other: disintegrations per minute (DPM)
- Value:
- 8 100
- Test group / Remarks:
- 10 % (v/v)
- Remarks on result:
- other: 10%
- Parameter:
- other: disintegrations per minute (DPM)
- Value:
- 31 487
- Test group / Remarks:
- 25 % (v/v)
- Remarks on result:
- other: 25%
Any other information on results incl. tables
No test substance-related clinical signs were observed in any group. The body weight of the animals, recorded at the start of acclimatisation period and prior to necropsy, was within the range commonly recorded for animals of this strain and age.
Applicant's summary and conclusion
- Interpretation of results:
- other: Skin sensitiser (1A)
- Remarks:
- in accordance with EU CLP (EC no 1272/2008 and its amendments)
- Conclusions:
- The test substance is sensitising to skin. The substance is a skin sensitizer (1A) in the Local Lymph Node Assay in mice (OECD TG 429),
- Executive summary:
In study, performed according to OECD TG 429 (Local Lymph Node Assay in mice), in compliance with GLP, five groups of 4 female mice were treated by topical application to the dorsal surface of each ear lobe with 1, 2.5, 5, 10 and 25 % solution of test substance in acetone/olive oil (4:1 v/v) for three consecutive days. A positive control group of four mice was treated with alpha-hexylcinnamaldehyde (25 %) and a vehicle control group was treated with the vehicle alone. Five days after the first topical application the mice were injected intravenously into a tail vein with 3H-thymidine, the draining auricular lymph nodes excised, pooled per group and their proliferative capacity measured by the incorporation of 3H-thymidine in a β-scintillation counter. The stimulation indices were 0.6, 0.7, 0.6, 1.3, and 4.9 for 1, 2.5, 5, 10 and 25 % solution of test substance, respectively. For the positive control a stimulation index of 7.2 was obtained. Based on the results of the study, the test substance is considered to give a positive result in the LLNA test.
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