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EC number: 234-054-3 | CAS number: 10519-11-6
- 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:
- 22 March 2016 - 12 April 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- 2001
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Decahydro-2-naphthyl acetate
- EC Number:
- 234-054-3
- EC Name:
- Decahydro-2-naphthyl acetate
- Cas Number:
- 10519-11-6
- Molecular formula:
- C12H20O2
- IUPAC Name:
- decahydronaphthalen-2-yl acetate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Sprague-Dawley (Crl:CD(SD)), SPF
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Females nulliparous and non-pregnant: Not reported
- Age at study initiation: 8 weeks old
- Weight at study initiation: 181.6 to 186.8g
- Fasting period before study: Animals were fasted overnight, approximately 16 hours prior to dosing.
- Housing: Animals were individually caged in stainless wire mesh cages (260 x 350 x 210 mm)
- Diet (e.g. ad libitum): Pelleted rodent chow, provided ad libitum approximately 4 hours after dosing.
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.5 to 24.0°C
- Humidity (%): 43.5 to 58.5%
- Air changes (per hr): 10 to 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle, 150 to 300 Lux
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 500 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg body weight
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg body weight
DOSAGE PREPARATION (if unusual): The test substance was weighed and placed in a bottle. A small amount of vehicle was added and mixed using a vortex mixer until dissolved. The vehicle was gradually added to yield the desired concentration.
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Due to the low expected toxicity of the test substance, based on the information supplied by the sponsor, a starting dose of 5000 mg/kg was administered in one animal in Step 1 of the study. - Doses:
- 5000 mg/kg
- No. of animals per sex per dose:
- 1 for Step 1, 2 for Step 2
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed at 30 minutes after dosing and at 1, 2, 4 and 6 hours after dosing on Day 0 and once daily thereafter for 14 days.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs and body weight - Statistics:
- Statistical analysis was not performed. Mean scores and values were determined.
Results and discussion
- Preliminary study:
- In Step 1, the test animal did not die after 3 days.
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- All animals survived the duration of the study. There were no effects on mortality.
- Clinical signs:
- A decrease of fecal volume was observed in all animals on Days 1 and 2 after dosing and it disappeared on Day 3 after dosing. This was considered to be a test substance-related temporary change.
- Body weight:
- A decrease in body weight was observed in one animal on Day 1 after dosing and a tendency of decreaed body weight gain was observed in two animals on Day 1 after dosing and in one animal on Day 3 after dosing. The animals returned to normal on Days 3 and 7. These changes were considered to be test substance-related effects.
- Gross pathology:
- No grossly visible evidence of morphological abnormalities were observed in any animals.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The oral LD50 was determined to be >5000 mg/kg bw.
- Executive summary:
The acute oral toxicity of the test item was determined in a limit test using the acute toxic class method. The test item dose (5000 mg/kg bw) was administered at a volume of 10 mL/kg bw in a corn oil vehicle by oral gavage. One female Sprague-Dawley rat was administered the dose in Step 1 and no mortality was observed after 3 days. Based on this result, two animal were administered the same dose and observed for 14 days. The oral LD50 was determined to be >5000 mg/kg bw. The study is reliable without restriction (Klimisch 1) as it was GLP-compliant and was conducted according to OECD Guideline 423.
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