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EC number: 422-120-6 | CAS number: 166432-53-7
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 29-11-1994 to 13-01-1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study performed under GLP. All relevant validity criteria were met.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- inspected: October 1992 ; signature: December 1992
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 422-120-6
- EC Name:
- -
- Cas Number:
- 166432-53-7
- Molecular formula:
- C14H22O
- IUPAC Name:
- 2-methyl-4-(2,2,3-trimethylcyclopent-3-en-1-yl)pent-4-enal
- Test material form:
- liquid
- Details on test material:
- - Physical state: Liquid
- Storage condition of test material: in the refrigerator in the dark
- Other: clear colourless liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Remarks:
- Crl: CD (SD) BR strain (VAF plus)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Recognised supplier
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 4 - 6 weeks.
- Weight at study initiation: 95-119 g (500 mg/kg and/or 2000 mg/kg bw range-finding test; sentinels); Main study: Male: 100-109 g and/or Female: 105 – 111 g (2000 mg/kg). Applicant assessment indicates: the weight variation did not exceed ±20% of the mean weight in the definitive test.
- Fasting period before study: Overnight before dosing and three to four hours after dosing.
- Housing: Group housed in groups of up to five by sex ; in suspended grid-bottomed cages above carboard lined excreta trays.
- Diet (e.g. ad libitum): Certified diet from recognised supplier, provided ad libitum (except for fasting period).
- Water (e.g. ad libitum): ad libitum (except for fasting period)
- Acclimation period: At least 5 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 24
- Humidity (%): 40 - 66%
- Air changes (per hr): Not reported, however reported as air conditioned
- Photoperiod: 12 h light / 12 h dark
IN-LIFE DATES: From: 29-11-1994 To: 21-12-1994
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Remarks:
- 0.5%
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: For the purpose of the range finding study: at 500 mg/kg and 2000 mg/kg bw dose levels the test item was freshly prepared, as required, as a solution in 0.5% CMC at 25 and 100 mg/mL to achieve the required does levels by bodyweight. For the main test: at 2000 mg/kg bw dose level the test item was freshly prepared, as required, as a solution in 0.5% CMC at 100 mg/mL to achieve the required does level by bodyweight.
- Amount of vehicle (if gavage): Test Item dose volume was 20 mL/kg (of bodyweight) in 0.5% CMC in both the range finding study: at 500 mg/kg and 2000 mg/kg bw and the main test: at 2000 mg/kg bw
- Justification for choice of vehicle: The vehicle was selected based on trial formulations performed.
- Lot/batch no. (if required): See full study report.
- Purity: See full study report.
MAXIMUM DOSE VOLUME APPLIED: 500 mg/kg bw dose level: 20 mL/kg of test item in vehicle (0.5% CMC) ; 2000 mg/kg bw dose level: 20 mL/kg of test item in vehicle (0.5% CMC).
DOSAGE PREPARATION (if unusual): Not applicable. The test item was prepared in the vehicle.
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: In the absence of data regarding the toxicity of the test item, 500 mg/kg was chosen as the starting dose based on guideline recommendations within the range-finding test in one female before dosing at 2000 mg/kg bw a further single female. The starting dose of the main test was based on the observations from the range-finding test (lack of mortality, no clinical signs of toxicity, expected gains in bodyweight up to day 7). - Doses:
- 500 mg/kg bw and 2000 mg/kg bw (range finding test)
2000 mg/kg bw (main study) - No. of animals per sex per dose:
- 500 mg/kg bw in 0.5% CMC vehicle (starting dose) : 1 female (range finding study)
2000 mg/kg bw in 0.5% CMC vehicle (follow up dose) : 1 female (range finding study).
2000 mg/kg bw: 5 males and 5 females (main study) as applicable; total 5 per sex per dose level - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations were made 0.5, 1, 2, and 4 hours after dosing and then daily for fourteen days. Individual body weights were recorded on Day 0 (the day of dosing) and on Days 8 and 15.
- Necropsy of survivors performed: yes
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- 500 mg/kg bw (range finding test): No mortality
2000 mg/kg bw (range finding test and definitive test): No mortality - Clinical signs:
- other: 500 mg/kg bw (range finding test): No signs of systemic toxicity were noted. 2000 mg/kg bw (range finding test and definitive test): No signs of systemic toxicity were noted.
- Gross pathology:
- 500 mg/kg bw (range finding test): No abnormalties were noted at necropsy.
2000 mg/kg bw (range finding test and definitive test): No abnormalties were noted at necropsy in all females and 4/5 males. One male an enlarged spleen at necropsy.
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 oral LD50 was estimated to be greater than 2000 mg/kg bw in male/female rats. Under the conditions of this study and under the Globally Harmonized Classification System of Classification and Labelling of Chemicals (GHS), the LD50 cut-off value was considered to be greater than 5000 mg/kg body weight.
- Executive summary:
The study was performed according to OECD TG 420 and EU Method B.1 under GLP to assess the acute oral toxicity of the test item following a single oral administration in the male/female Crl: CD (SD) BR (VAF plus) strain rat by the fixed dose method. The test item was administered by oral gavage in an initial range finding test at 500 mg/kg bw in a solution of 0.5% CMC (carboxymethyl cellulose) to one female and following an absence of toxicity then at 2000 mg/kg bw in 0.5% CMC (carboxymethyl cellulose) to one female. There was an absence of toxicity up to day 7 in both females. Subsequently, in a main study further groups of five fasted males and females was given a single oral dose of test item, at a dose level of 2000 mg/kg body weight in 0.5% CMC (carboxymethyl cellulose). No mortalities were observed. No significant clinical signs were noted and all maintained a healthy appearance throughout the observation period terminated on day 15. All males and females gained bodyweight. There were no abnormalties noted at necropsy in all females and 4/5 males. One male an enlarged spleen at necropsy. Under the conditions of this study, the oral LD50 was estimated to be greater than 2000 mg/kg bw in the male/female Crl: CD (SD) BR rat. Applicant assessment indicates that the estimated LD50 cut-off is considered to be > 5000 mg/kg bw on the basis of absence of significant clinical toxicological effects and/or bodyweight increases in all males/females.
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