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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
Endpoint summary
Administrative data
Description of key information
LD50 >2000 mg/kg for oral study.
LD50 >10000 ml/kg for dermal study.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- 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
- 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
- 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 - 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.
- 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.
- 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.
Reference
The acute oral LD50 of the test material was found to be greater than 2000 mg/kg bw.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- No data
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: Older proprietary study conducted prior to development of GLP and test guideline. Reporting is considered minimal, and the methodology is not comparable to the recommended guideline.
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The study was conducted prior to adoption of the current test guidelines. Four rabbits (2/sex) were exposed to a limit dose of the test substance for 24 hours. The application site in 1 rabbit/sex was abraded prior to application.
- GLP compliance:
- no
- Remarks:
- Conducted prior to development of GLP
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: No data
- Age at study initiation: No data
- Weight at study initiation: 1.9 to 3.3 kg - Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: A single application of test material was made to the clipped intact and abraded skin of the backs and flanks of each animal, at a dose of 10 mL/kg bw. The application site of one male and one female from each group was prepared by making epidermal abrasions every 2-3 cm longitudonally over the exposure area. The abrasions penetrated the stratum corneum, but not the dermis.
- Type of wrap if used: The test substance was applied beneath dental dam binders which were placed around the trunk of each animal. The trunk was then covered with a gauze and adhesive bandage.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Test sites were sponged with warm tap water
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10 mL/kg bw
- Concentration (if solution): Applied undiluted - Duration of exposure:
- 24 hours
- Doses:
- 10 mL/kg bw (equivalent to approximately 10000 mg/kg bw)
- No. of animals per sex per dose:
- 2/sex
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days.
- Frequency of observations and weighing: Observations for signs of toxicity, mortality and dermal irritation were made once daily following removal of the dental dam, for 14 days. Body weights were recorded prior to dosing, and again at 14 days.
- Necropsy of survivors performed: Yes (Day 14).
- Other examinations performed: Clinical signs, body weight, dermal irritation. - Statistics:
- Not required.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 10 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: Based on a dose of 10 mL/kg bw
- Mortality:
- No mortalities occurred.
- Clinical signs:
- other: No clinical signs were noted during the study.
- Gross pathology:
- No abnormalities were detected at necropsy.
- Other findings:
- Dermal irritation was observed at the test sites. Well-defined to moderate erythema and very slight to slight oedema were noted 24 hours after test substance removal, at the intact skin sites. The oedema cleared by Day 4 and the erythema cleared by Day 10. Well-defined to moderate erythema and slight oedema were noted at the abraded test sites, persisting until study termination; slight to well-defined erythema and slight oedema were noted at the final observation.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the study, the acute dermal LD50 was estimated to be greater than 10 mL/kg bw, equivalent to approximately 10000 mg/kg bw.
- Executive summary:
The acute dermal toxicity of aurantiol pure (RIFM 71 -32) was investigated in a group of two male and two female New Zealand White rabbits. The test substance was applied to the clipped back skin of each rabbit and held in place under an occlusive dressing for 24 hours. A dose of 10 mL/kg bw was applied to each rabbit. The test site was abraded on 1 male and 1 female prior to application. The rabbits were observed for signs of toxicity, mortality and dermal irritation daily for 14 days following application. Gross necropsies were performed on all animals at study termination (Day 14). There were no mortalities, and no clinical signs of toxicity were observed during the study. Well-defined to moderate erythema and slight to moderate oedema was observed in all rabbits. Dermal irritation had cleared by Day 10 in the intact sites, but persisted to Day 14 in the abraded test sites. No abnormalities were detected at necropsy.
Under the conditions of the study, the acute dermal LD50 was estimated to be greater than 10 mL/kg bw, equivalent to approximately 10000 mg/kg bw.
Reference
The acute dermal LD50 of the test material was reported to be > 10 mL/kg bw, equivalent to approximately >10000 mg/kg bw.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 10 000 mg/kg bw
Additional information
Oral
An acute oral toxicity test was carried out on groups of young adult rats at dose levels of 2 gms/kg bodyweight. No deaths and no overt signs of toxicity were observed during the fourteen day observation periods. No toxicity was observed in the study at the limit of 2 gms/kg bw. The LD50 was therefore greater than 2 gms/kg bodyweight.
In a separate supporting oral toxicity study testing was carried out on groups of young adult rats at dose levels of 5 ml/kg bodyweight. Again, no deaths and no overt signs of toxicity were observed during the fourteen day observation periods.
Dermal
In the study, 4 animals (two male and two female) were dosed at 10 ml/kg bodyweight and observed for 14 days. No toxicity was seen in the 4 animals during the 14 day observation period.
Symptomatology: Mild erythema on rabbits lasting 24 hours. No toxicity was observed in the study at the limit of 10 ml/kg bw. The LD50 was therefore greater than 10 ml/kg bodyweight.
Justification for classification or non-classification
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.
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