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EC number: 203-161-7 | CAS number: 103-95-7
- 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

Toxicity to reproduction: other studies
Administrative data
- Endpoint:
- toxicity to reproduction: other studies
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
Cross-reference
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- GLP compliance:
- no
- Type of method:
- in vivo
Test material
- Reference substance name:
- Cylcamen Aldehyde Extra
- IUPAC Name:
- Cylcamen Aldehyde Extra
- Reference substance name:
- 3-p-cumenyl-2-methylpropionaldehyde
- EC Number:
- 203-161-7
- EC Name:
- 3-p-cumenyl-2-methylpropionaldehyde
- Cas Number:
- 103-95-7
- Molecular formula:
- C13H18O
- IUPAC Name:
- 2-methyl-3-[4-(propan-2-yl)phenyl]propanal
- Reference substance name:
- 3-p-cumenyl-2methylpropionaldehyde
- IUPAC Name:
- 3-p-cumenyl-2methylpropionaldehyde
- Test material form:
- other: liquid
- Details on test material:
- Name : Cyclamen Aldehyde
CAS # : 103-95-7
CAS name : Benzenepropanal, α-methyl-4-(1-methylethyl)-
EC # : 203-161-1
EC name : 3-p-cumenyl-2methylpropionaldehyde
IUPAC name : 2-methyl-3-[4-(propan-2-yl)phenyl]propanal
Constituent 1
Constituent 2
Constituent 3
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on exposure:
- Rabbits were administered the test substance, Cyclamen Aldehyde, and/or the control article, corn oil, formulations orally (stomach tube) once daily on Day 1 of study (DS 1) to 14.
- Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- 14 days
- Frequency of treatment:
- once per day
- Duration of test:
- 14 days
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
0 mg/kg
Basis:
actual ingested
- Remarks:
- Doses / Concentrations:
30 mg/kg
Basis:
actual ingested
- Remarks:
- Doses / Concentrations:
100 mg/kg
Basis:
actual ingested
- Remarks:
- Doses / Concentrations:
300 mg/kg
Basis:
actual ingested
- No. of animals per sex per dose:
- 5 male
0 female - Control animals:
- yes, concurrent vehicle
- Details on study design:
- The objective of this study was to determine the potential toxicity of Cyclamen Aldehyde, when given orally via stomach tube for 14 consecutive days to male New Zealand White rabbits. In addition, potential effects on the male reproductive organs, including sperm parameters were assessed.
The study design was as follows:
Rabbits were administered the test substance, Cyclamen Aldehyde, and/or the control article, corn oil, formulations orally (stomach tube) once daily on Day 1 of study (DS 1) to 14.
The following parameters and endpoints were evaluated in this study: viability, clinical signs, body weights, body weight changes, food consumption, gross and microscopic pathology, sperm evaluations (motility, count, and morphology), and organ weights. Urine samples were collected from all rabbits on Day 15 prior to euthanasia for possible future evaluation.
Results and discussion
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 300 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male
Observed effects
Body weights, body weight gains and food consumption values (g/day and g/kg/day) were comparable among the groups and were unaffected by dosages of Cyclamen Aldehyde as high as 300 mg/kg/day.
Cyclamen Aldehyde did not affect the weights of the reproductive (testes, epididymides, seminal vesicles [with and without fluid] or prostate) or non-reproductive (liver or kidneys) at any dosage level. There were no microscopic findings in the testes or epididymides at 300 mg/kg/day. In addition, there were no noteworthy changes in sperm motility (number and percentage of motile sperm or nonmotile sperm from ejaculated semen samples), sperm concentration (total and cauda epididymal sperm count and density) or sperm morphology at any dosage level.
Organ Weights
Terminal body weights were comparable among the four dosage groups. The weights of the epididymides, left cauda epididymis, testes, seminal vesicles (with and without fluid) and prostate and the ratios of these organ weights to terminal body weight were unaffected by dosages cyclamen aldehyde as high as 300 mg/kg/day.
In addition, there were no test substance-related changes in the non-reproductive organs (i.e., liver or paired kidneys) at any dosage level. There were no patterns, trends, or correlating data to suggest these values were toxicologically relevant. The apparent increase in the absolute and relative (% body weight) weights of the liver that occurred at 300 mg/kg/day (18% and 21% over controls, respectively) was largely attributed to one rabbit (no. 8596) in the 300 mg/kg/day dosage group with an absolute liver weight of 111.1 g (range: 70.1 to 92.3 for other rabbits in the group). Exclusion of this rabbit from summarization would still result in a higher group mean weight in comparison to the control group value. The absolute and relative (% body weight) weights of the paired kidneys were also increased in the 300 mg/kg/day dosage group (1 1% and 13% over controls, respectively), again attributed to one rabbit (no. 8595) in this dosage group. Overall, the individual organ weight differences observed were considered incidental and unrelated to administration of cyclamen aldehyde.
Sperm Evaluations
The values for the number of motile sperm and total sperm count from ejaculated semen samples were highly variable across the dosage groups, including the control group. Whilst a slight trend in the mean number of motile sperm (596.6, 543.3 and 431.0 in the 30, 100 and 300 mg/kg/day dosage groups, respectively, vs. 627.0 in controls) and total sperm count (616.6, 595.5 and 496.2 in the 30, 100 and 300 mg/kg/day dosage groups, respectively, vs. 679.0 in controls) from ejaculated samples in the cyclamen aldehyde-treated groups was observed, individual values were highly variable and the lowest reported individual values were within the range of the control group values. In general, all values across all treated groups were within the range of the concurrent control group values and/or the historical control range at the Testing Facility. The observed trend in sperm motility and total sperm count was not considered an adverse finding of Cyclamen Aldehyde.
Values for percent motile sperm, number of nonmotile sperm from the semen ejaculate sample and cauda epididymal sperm count and density were comparable among the four dosage groups.
In addition, there were no patterns or trends in the morphology data to suggest any toxicological relevance.
Applicant's summary and conclusion
- Conclusions:
- Cyclamen Aldehyde was administered orally to male rabbits for 14 days at dosages as high as 300 mg/kg/day. There were no noteworthy changes in reproductive organs, non-reproductive organs or sperm parameters were observed.
- Executive summary:
Cyclamen Aldehyde when administered orally to male rabbits for 14 days at dosages as high as 300 mg/kg/day did not produce any clinical observations, changes in body weight or food consumption or affect the weights of any reproductive or non-reproductive organs that were evaluated. There were no microscopic findings in the testes or epididymides at 300 mg/kg/day, and no noteworthy changes in sperm parameters were observed.
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