Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 946-958-1 | CAS number: -
- 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:
- The study was conducted between 11 July 2000 and 25 July 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline 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 401 (Acute Oral Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- ST 30 C 00
- IUPAC Name:
- ST 30 C 00
- Reference substance name:
- Reaction products of 7-hydroxy-3,7-dimethyloctanal and methyl 2-aminobenzoate
- IUPAC Name:
- Reaction products of 7-hydroxy-3,7-dimethyloctanal and methyl 2-aminobenzoate
- Test material form:
- other: clear liquid
- Details on test material:
- - Name of test material (as cited in study report): ST 30 C 00 (Aurantiol pure - confirmed in RIFM database)
- Physical state: clear liquid
- Lot/batch No.: #AB6271
- Stability under test conditions: expected to be stable for duration of study
- Storage condition of test material: room temperature
- Other: expiry date 18 November 2001
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Ace Animals, Inc., Boyer Town, PA, USA
- Age at study initiation: 8-9 weeks
- Weight at study initiation: 182-194 g males and 146-170 g females
- Fasting period before study: 18 hours; feed was returned to the cages approximately 3.5 hours after dosing
- Housing: singly in suspended stainless steel cage with mesh floor
- Diet (e.g. ad libitum): ad libitum Purina Rodent Chow #5012 (except during fasting)
- Water (e.g. ad libitum): ad libitum access to filtered tap water
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-24
- Humidity (%): 40-54
- Air changes (per hr): no details
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 11 July 2000 To: 25 July 2000
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- Individual doses were calculated based on initial body weight and were in the range of 0.28 to 0.38 mL. The specific gravity of the undiluted test substance was stated to be 1.028 g/mL
- Doses:
- Animals were gavaged with a single dose of 2000 mg/kg bw
- No. of animals per sex per dose:
- Five
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed at 1 and 3 hours post-dosing and at least once daily thereafter for 14 days. Body weights were recorded on Day 0 (shortly before dosing) and on Days 7 and 14 (termination)
- Necropsy of survivors performed: Yes, at study termination (Day 14)
- Other examinations performed: Clinical signs (mortality, signs of gross toxicity and behavioural changes), body weight - Statistics:
- Not required.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No mortality at the limit dose
- Mortality:
- There were no mortalities.
- Clinical signs:
- other: One rat appeared hypoactive at 1 hour post dosing. No other clinical signs were observed and all other rats appeared active and healthy during the observation period.
- Gross pathology:
- No gross abnormalities were observed at terminal necropsy.
- Other findings:
- No other findings.
Any other information on results incl. tables
The acute oral LD50 of the test material was found to be greater than 2000 mg/kg bw.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute oral LD50 was >2000 mg/kg bw.
- Executive summary:
The acute oral toxicity of ST 30 C 00 (aurantiol pure) was evaluated in Sprague-Dawley rats, according to OECD Guideline 401. Five males and five female rats were administered the undiluted test substance by gavage, at a dose of 2000 mg/kg bw. The animals were observed for mortality, signs of reaction to treatment and behavioural changes at least once daily for 14 days. Bodyweights were recorded on the day of administration and again on Days 7 and 14. All rats were euthanised on Day 14 and gross necropsies were performed. All rats survived and all gained weight during the study. With the exception of one rat that appeared hypoactive 1 hour post-dosing, all animals appeared active and healthy during the study. No abnormalities were detected at necropsy. Under the conditions of the study, the acute oral LD50 of aurantiol pure was found to be > 2000 mg/kg bw.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.