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EC number: 700-339-0 | CAS number: 850997-10-3
- 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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 09-05-2001 to 23-05-2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Guideline study performed under GLP. All relevant validity criteria were met.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- inspected: September 2009 ; signature: November 2009
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 3-(4,4-dimethylcyclohex-1-en-1-yl)propanal
- EC Number:
- 700-339-0
- Cas Number:
- 850997-10-3
- Molecular formula:
- C11H18O
- IUPAC Name:
- 3-(4,4-dimethylcyclohex-1-en-1-yl)propanal
- Test material form:
- liquid
- Details on test material:
- - Physical state: Liquid
- Storage condition of test material: Refrigerator (between 0 and 10ºC under nitrogen)
- Other: colourless
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- HsdRccHan : WIST
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Rationale for alternative/additional species to rat (if applicable): Not applicable.
- Source: Recognised supplier (documented in the full study report)
- Females (if applicable) nulliparous and non-pregnant: yes
- Rationale for use of males (if applicable): Conducted according to guideline requirements of the time.
- Age at study initiation: ca. 8 to 12 weeks age (nulliparous and non-pregnant)
- Weight at study initiation: > 200 g (actual: 234 – 251 g males and 207 – 225 g females
- Fasting period before study: Not applicable
- Housing: during acclimation and observation period: group housed by sex; during exposure: individually housed in polypropylene cages furnished with softwood bedding.
- Historical data: The test laboratory possesses historical control data.
- Diet (e.g. ad libitum): Certified diet from recognised supplier, provided ad libitum.
- Water (e.g. ad libitum): ad libitum.
- Acclimation period: At least 5 days.
- Microbiological status when known: No issues reported.
- Method of randomisation in assigning animals to test and control groups : Random allocation.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25 °C (or 22 ± 3 °C)
- Humidity (%): 30 - 70%
- Air changes (per hr): > 15 air changes per hour
- Photoperiod: 12 h light / 12 h dark
IN-LIFE DATES: 16-12-2009 to 30-12-2009
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: the day before treatment the back and flanks were clipped free of hair. Dorsal area application.
- % coverage: Approximately 10% of total body surface
- Type of wrap if used: The area of application was covered by a semi-occlusive dressing and wrapped with a piece of elastic self-adhesive bandage.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): After the 24-hour contact period the bandage was carefully removed, and the treated skin and surrounding hair wiped with cotton wool moistened with distilled water to remove any residual test item.
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg (or dose volume 2.23 mL/kg)
- Concentration (if solution): See below.
- Constant volume or concentration used: 2.23 mL volume ; at a dose level of 2000 mg/kg bw test item.
- For solids, paste formed: Not applicable
VEHICLE
- Amount(s) applied (volume or weight with unit): Not applicable
- Concentration (if solution): Not applicable
- Lot/batch no. (if required): Not applicable
- Purity: Not applicable - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 per sex per dose (5 male/5 female)
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations and mortality checks were conducted at approximately 0.5, 1, 2, and 4 hours and subsequently once daily for days 2 to 15. Local effects were examined once daily days 2 to 15 after the completion of the 24-hour exposure period. Full details on the scoring and criteria (appears consistent with Draize for Erythema) are given in the full study report. Individual bodyweights were recorded prior to application of the test item on Day 0 and on Days 7 and 14.
- Necropsy of survivors performed: yes - Statistics:
- No statistical analyses were performed.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed.
- Clinical signs:
- other: - Clinical observations: No signs of systemic toxicity were noted during the observation period. - Dermal reactions: Very slight erythema (score = 1) was noted at the treatment site of two males and two females three days after dosing, two males and one f
- Gross pathology:
- No abnormalities were noted at necropsy.
- Other findings:
- - Organ weights: Not reported.
- Histopathology: Not reported. No macropathological abnormalities.
- Potential target organs: Not applicable.
- Other observations: Not applicable.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this study the dermal LD50 was established to exceed 2000 mg/kg bw in male/female Wistar rat. Applicant assessment indicates under the conditions of this study, and according to the GHS criteria, the LD50 cut-off value was considered to be greater than 5000 mg/kg body weight on the basis of absence of significant clinical toxicological effects and/or bodyweight increases in all males/females.
- Executive summary:
The study was performed according to OECD TG 402 and EU Method B.3 Acute Toxicity (Dermal) and in accordance with GLP to assess the acute dermal toxicity of the test item in the Wistar HsdRccHan : WIST strain rat. A group of ten animals (five males and five females) was given a single, 24 hour, semi-occluded dermal application of the undiluted test item to intact skin at a dose level of 2000 mg/kg body weight. Clinical signs and body weight development were monitored during the study. All animals were subjected to gross necropsy. There was no mortality during the study. There were no signs of system toxicity or abnormalities on necropsy. It was considered there was no toxicologically significant effects on bodyweight. All males/females gained bodyweight during the study. Very slight erythema (score = 1) was noted at the treatment site of two males and two females three days after dosing, two males and one female four days after dosing and two males five and six days after dosing. Other skin reactions noted at the treatment site of seven animals (two males and five females) two to six days after dosing were loss of skin elasticity, brown discolouration of the epidermis, small superficial scattered scabs and slight desquamation. Treatment sites appeared normal three, four or seven days after dosing. No signs of dermal irritation were noted at the treatment site of three males. The dermal LD50 was established to exceed 2000 mg/kg bw in male/female Wistar HsdRccHan : WIST rat. Applicant assessment indicates under the conditions of this study, and according to the GHS criteria, the LD50 cut-off value was considered to be greater than 5000 mg/kg body weight on the basis of absence of significant clinical toxicological effects and/or bodyweight increases in all males/females.
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