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EC number: 700-052-0 | CAS number: 60046-50-6
- 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:
- 09/10 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The test was in accordance with the OECD Guidelines for Testing of Chemicals, No. 423, "Acute Oral Toxicity", 1996., and the Directive 96/54/EEC, B.1 tris "Acute Toxicity-Oral-Acute Toxic Class Method", 1996.
Cross-reference
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- (4R,6R)-4-hydroxy-2,2,6-trimethylcyclohexan-1-one
- EC Number:
- 700-052-0
- Cas Number:
- 60046-50-6
- Molecular formula:
- C9H16O2
- IUPAC Name:
- (4R,6R)-4-hydroxy-2,2,6-trimethylcyclohexan-1-one
- Details on test material:
- - Name of test material (as cited in study report): Actinol
- Physical state: solid
- Analytical purity: 99.5 %
- Lot/batch No.: 410016
- Expiration date of the lot/batch: 31 July 2000
- Stability under test conditions: stable under storage conditions, dissolved stable for 5 days at room temperature
- Storage condition of test material: room temperature, protected from sun light
- Other:
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: HanIbm: WIST (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: RCC Ltd, Biotechnology & Animal Breeding Division, Füllinsdorf, Switzerland
- Age at study initiation: females 10 weeks, males 8 weeks
- Weight at study initiation:
- Fasting period before study: Overnight prior to intubation
- Housing: groups of three males or three females in Makrolon type-4 cages with standard soft bedding ("Lignocel", Schill AG, Muttenz, Switzerland)
- Diet (e.g. ad libitum): pelleted standard Kliba 3433 ad libitum, batch no. 39/99 (Provimi Kliba AG, Kaiseraugst, Switzerland)
- Water (e.g. ad libitum): community tap water from Itingen, ad libitum
- Acclimation period: one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 40-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12 /12
IN-LIFE DATES: From: To:
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: bi-distilled water
- Details on oral exposure:
- Animals received a single dose of the test article n a mg/kg body weight basis by oral gavage following fasting for approximately 16 to 16.5 hours, but with free access to water. Food was provided again approximately 3 hours after dosing. The application volume was 10 mL/kg bodyweight. Oral route was chosen as this is one possible route of human exposure during manufacture, handling and use of the test substance.
- Doses:
- 2000 mg/kg bodyweight
- No. of animals per sex per dose:
- three
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Testing animals were checked four times for mortality and viability on day 1 and once daily during days 2 to 15. Bodyweights were determined on days 1, 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: Each animal was examined for changes in appearance and behaviour five times during day 1 and once daily during days 2-15. A description of all abnormalities was recorded. Necropsy was performed by experienced prosectors. At the end of the observation period on day 15, all animals were sacrificed by intraperitoneal injection of NARCOREN at a dose of at least 2.0 mL/kg bodyweight. The animals were examined macroscopically and all abnormalities recorded. - Statistics:
- No statistical analysis was used as no deaths occurred.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- No death occurred during the study.
- Clinical signs:
- Several clinical signs like slight to marked sedation, slight to moderate ataxia, ventral position and ruffled fur were observed on test day 1 in males and females. In one female, ventral position persisted until test day 2, whereas sedation, ataxia and hunched posture persisted until test day 3. Ruffled fur was observed in one female from test day 2 until test day 4. All clinical signs were reversible on test day 5.
- Body weight:
- The bodyweight of the animals was within the range of commonly recorded for this strain and age (Table 1).
- Gross pathology:
- No macroscopic findings were observed at necropsy.
Any other information on results incl. tables
Table 1: Bodyweights of testing animals.
Bodyweight in grams |
||||
Sex |
Animal number |
Day of treatment |
Day 8 |
Day 15 |
Female |
1 |
182.0 |
208.4 |
214.7 |
2 |
181.2 |
194.6 |
208.0 |
|
3 |
178.6 |
194.6 |
207.4 |
|
Male |
4 |
210.9 |
250.7 |
280.2 |
5 |
211.9 |
259.0 |
278.0 |
|
6 |
207.4 |
252.3 |
272.2 |
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Remarks:
- Migrated information
- Conclusions:
- The median lethal dose of Actinol after single oral administration to rats of both sexes, observed over a period of 14 days, could not be determined as no deaths occurred. LD50rat: greater than 2000 mg/kg bodyweight.
- Executive summary:
A test for the acute toxicity of the testing substance Actinol was carried out in three female and three male HanIbm: WIST (SPF) rats according to OECD Guideline for the Testing of Chemicals No. 423 and Directive 96/54/EEC, Annex B.1 tris. The testing animals received one single dose of Actionl by oral gavage. The test article was suspended in vehicle (bi-distilled water) at a concentration of 0.2 g/mL and administered at a volume of 10 mL/kg. The animals were examined for clinical signs five times during day 1 and once daily during days 2 -15. Mortality/viability were recorded together with clinical signs at the same time intervals. Bodyweights were recorded on day 1 prior to administration and on days 8 and 15. All animals were necropsied and examined macroscopically.
No death occurred during the study.
Several clinical signs like sedation, ventral position and ruffled fur were observed on test day 1 in males and females. All clinical signs were reversible on test day 5.
The bodyweight of the animals was within the range commonly recorded for this strain and age.
No macrocopic findings were observed at necropsy.
The median lethal dose of Actinol after a single oral dose to rats of both sexes, observed over a period of 14 days, could not be estimated as no death occurred.
LD50 rat: greater than 2000 mg/kg bodyweigth.
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