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EC number: 244-033-0 | CAS number: 20780-48-7
- 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:
- October 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- 3,7-dimethyloctan-3-yl acetate
- EC Number:
- 244-033-0
- EC Name:
- 3,7-dimethyloctan-3-yl acetate
- Cas Number:
- 20780-48-7
- Molecular formula:
- C12H24O2
- IUPAC Name:
- 3,7-dimethyloctan-3-yl acetate
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Remarks:
- BR strain (VAF plus)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK) Limited, Margate, Kent
- Age at study initiation: 4 - 6 weeks
- Weight at study initiation: mean females:102 g and males 104 g
- Fasting period before study: overnight before dosing
- Housing: groups of up to 5, by sex, in grid-bottomed cages suspended over cardboard lined excreta trays
- Diet: pelleted diet (SQC Rat and Mouse Maintenance Diet No. 1 Expanded, produced by Special Diets Services, Witham, Essex), ad libitum
- Water: drinking water, ad libitum
- Acclimation period: at least 5 days before dosing
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 23
- Humidity (%): 44 - 65
- Air changes: air conditioned
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg
- Justification for choice of vehicle: according to OECD guideline 420, not further specified
MAXIMUM DOSE VOLUME APPLIED: 10mL/kg
DOSAGE PREPARATION:
The test article was formulated in corn oil at a concentration of 200mg/mL to achieve a dose level of 2000 mg/kg bodyweight using an individual dose volume of 10mL/kg. All formulations were freshly prepared on the day of dosing.
Rationale for the selection of the starting dose: Results of a range finding study with 500 and 2000 mg/kg bw. - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were examined shortly after dosing and approximately 30 minutes, one, 2 and 4 hours after dosing for signs of toxicity or changes in appearance or behaviour. Animals were examined daily thereafter for a further 14 days. On the day of dosing all animals were weighed in order to calculate the individual dose volume to be administered. Animals were weighed again on days 2, 3, 4, 8 and 15.
- Necropsy of survivors performed: yes at the end of the 15 day observation period. The carcasses were subject to a gross necropsy, which included the opening of the thoracic and visceral cavities, opening and examination of the stomach and representative sections of the gastro-intestinal tract and examination of the major organs.
Results and discussion
- Preliminary study:
- 1st female dosed with 500mg/kg bw: Piloerection and hunched posture noted 4 hours after dosing; animal appeared healthy thereafter and survived treatment. 2nd female dosed with 2000mg/kg bw: No apparent effect; animal survived treatment.
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed.
- Clinical signs:
- There were no clinical signs of toxicity throughout the observation period.
- Body weight:
- There was no adverse effect on bodyweight gain in animals of either sex.
- Gross pathology:
- There were no abnormalities detected at necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified
- Remarks:
- based on CLP criteria
- Conclusions:
- Under the conditions of the test, the oral LD50 was > 2000 mg/kg bw. Based on this result, the substance does not need to be classified for acute toxicity in accordance with the criteria outlined in Annex I of the CLP Regulation (1272/2008/EC).
- Executive summary:
An acute oral fixed dose study was performed according to OECD TG 420 and in compliance with GLP. 10 Crl: CD (SD) rats (5 male/5 female) were exposed to a single dose of 2000 mg/kg bw test substance by oral gavage. Animals were observed for 14 -days after dosing for clinical signs and body weight gain. After 14 days gross necropsy was performed. No clinical signs of toxicity throughout the observation period were observed and there was no adverse effect on bodyweight gain in animals of either sex. No abnormalities were detected at necropsy. Under the conditions of the test, the LD50 was determined to be > 2000 mg/kg bw. Based on this result, the substance does not need to be classified for acute toxicity in accordance with the criteria outlined in Annex I of the CLP Regulation (1272/2008/EC).
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