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EC number: 309-831-6 | CAS number: 101227-08-1
- 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:
- 2005-02-07 - 2005-02-24
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Fatty acids, C16-18, 2-butyloctyl esters
- EC Number:
- 309-831-6
- EC Name:
- Fatty acids, C16-18, 2-butyloctyl esters
- Cas Number:
- 101227-08-1
- Molecular formula:
- C28H56O2 - C30H60O2
- IUPAC Name:
- Fatty acids, C16-18, 2-butyloctyl esters
- Reference substance name:
- Fatty acid, C16-18, 2-Butyloctylester
- IUPAC Name:
- Fatty acid, C16-18, 2-Butyloctylester
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): ISOFOL ESTER 1202
- Physical state: yellow liquid
- pH: not applicable
- volatility: not volatile at room temperature
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Oeutschland GmbH, 0-97633 Sulzfeld
- Age at study initiation:
- Weight at study initiation: 145-155 g
- Fasting period before study: overnight prior to dosing
- Housing: The rats were kept in transparent polycarbonate cages (macrolone type Ill, floor area 810 cm2) with two or three in each cage. The cages were cleaned and the bedding changed at least twice a week. Bedding was pinewood sawdust "Lignocel-Fasern" from Aliromin, 0-32791 Lage,
Lippe. Regular analyses for relevant possible contaminants are performed. Certificates of analysis are retained.
- Diet (e.g. ad libitum): A pelleted complete rodent diet "Altromin 1314" from Altromin GmbH, 0-32791 Lage, Lippe, was available ad libitum. Analyses for major nutritive components and relevant possible contaminants are performed regularly on the diet and certificates are retained.
- Water (e.g. ad libitum): The animals had free access to bottles with domestic quality drinking water acidified with hydrochloric acid to pH 2.5 in order to prevent microbial growth. Analyses for possible contaminants are performed regularly. Certificates of analysis are retained.
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C):21°C +- 3 °C
- Humidity (%): 55+-15 %
- Air changes (per hr): 10 times/hour
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: To: 2015-02-01 - 2015-02-24
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 1 rat in the preliminary study.
4 rats in the main study. - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Each rat was observed 30 min., 2, 4 and 6 hours after the administration and
thereafter daily for a period of 14 consecutive days. Body weight was recorded on days 0,7 and 14.
- Necropsy of survivors performed: All rats were killed by inhalation of CO2 on day 14 and subjected to a gross necropsy
examination.
- Other examinations performed: clinical signs - Statistics:
- not mentioned
Results and discussion
- Preliminary study:
- One female rat was given ISOLFOL ESTER 1202 in a 2000 mg/kg b.w. dose. Slight signs of toxicosis were observed in this rat. Animal No. 1 showed a hunched posture and piloerection 30 min, 2 and 4 hours after the application of the test item. After 6 hours piloerection was still obseNed. Fromday 1 to the end of the obseNation period on day 14 no abnormalities were revealed. The post mortem inspection revealed no pathological abnormalities.
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: limit test, 2000 mg/kg bw is the only dose tested
- Mortality:
- No mortalities were obserded.
- Clinical signs:
- Animals No. 2, No. 3, No. 4 and No. 5 showed a hunched posture and piloerection 30 min and 2 hours after the application of the test item. After 4 hours piloerection was still obseNed. On day 0 after 6 hours and from day 1 to the end of the observation period on day 14 no abnormalities were revealed.
- Body weight:
- no effects, normal body weight gain
- Gross pathology:
- The post mortem inspection revealed no pathological abnormalities.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Conclusions:
- Under the experimental conditions described in this final report the LD50 of ISOLFOL ESTER 1202 according to OECD 420 was > 2000 mg/kg.
- Executive summary:
The acute oral toxicity of Fatty acids, C16-18 (even numbered), 2-butyloctyl esters was determined in 4 female Wistar rats each receiving 2000 mg/kg bw of the test material by oral gavage (limit test). The observation period was 14 days.
None of the animals died.
The acute oral LD50 was determined to be > 2000 mg/kg bw in rats.
This study is considered acceptable. It follows the principles of the retracted OECD test guideline 420 (Acute Oral Toxicity).
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