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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 405-800-7 | CAS number: 27955-94-8 THPE; TRIS(P-HYDROXYPHENYL)ETHANE; TRIS(PARA-HYDROXYPHENYL)ETHANE
- 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
Oral: EU Method B.1; rat LC50 >5000 mg/kg. Reliability = 1
Inhalation: No study available
Dermal: EU Method B.3; rat LD50 >2000 mg/kg. Reliability = 1
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Deviations:
- no
- Remarks:
- The study was conducted according to guideline in effect at time of study conduct.
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: Crl:CD® (SD) BR VAF plus
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 4-6 weeks
- Weight at study initiation: 98-116 g
- Fasting period before study: not reported
- Housing: groups of up to 5 rats of the same sex in metal cages with wire mesh floors
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-23
- Humidity (%): mean value was 55%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- oral: gavage
- Vehicle:
- other: 1% w/v aqueous methylcellulose
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 50%
- Amount of vehicle (if gavage): 5.0 mL/kg body weight
- Justification for choice of vehicle: not reported
MAXIMUM DOSE VOLUME APPLIED: 10.0 mL/kg body weight
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: A preliminary test was carried out using a dose of 2.5 g/kg. The rationale was not reported. - Doses:
- 2.5 g/kg (preliminary test)
5.0 g/kg (main study) - No. of animals per sex per dose:
- 2/sex/dose (preliminary test)
5/sex/dose (main study) - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 5 days (preliminary study); 14 days (main study)
- Frequency of observations and weighing: observation soon after dosing, at frequent intervals for the remainder of Day 1, and twice daily for the rest of the observation period. Rats were weighed on Days 1 (day of dosing), 8, and 15 (main study).
- Necropsy of survivors performed: yes (main study) - Statistics:
- No statistical analyses were reported.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Mortality:
- There were no deaths.
- Clinical signs:
- other: Piloerection was observed in all rats within 5 minutes of dosing and throughout the remainder of Day 1. There were no other clinical signs, and recovery was complete, as judged by external appearance and behaviour, by Day 2.
- Gross pathology:
- Gross pathology findings were normal.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- LD50 >5000 mg/kg
- Executive summary:
The test substance was then suspended in 1% aqueous methylcellulose and given as a single 5000 mg/kg oral dose by gavage to 5 male and 5 female rats. The rats were then observed for 14 days for mortality and clinical signs, and body weights were recorded on Days 1, 8, and 15. There were no deaths during the observation period. The only clinical sign was piloerection on Day 1. All but one male rat had normal body weight gain. Gross necropsy findings were normal. The acute oral LD50was greater than 5000 mg/kg.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
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:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- Remarks:
- The study was conducted according to the test guidelines in effect at the time of study conduct.
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: Crl:CD® (SD) BR VAF plus
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 7-10 weeks
- Weight at study initiation: 200-252 g
- Fasting period before study: not reported
- Housing: individually in metal cages with wire mesh floors
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-23
- Humidity (%): mean value 47%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- occlusive
- Vehicle:
- water
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 50X50 mm
- % coverage: 10% of total body surface
- Type of wrap if used: gauze held in place with an impermeable dressing encircled firmly around the trunk.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): washed with warm water
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.0 g/kg of body weight
- Concentration (if solution): 71.4% v/v in distilled water; paste, not a solution
- Constant volume or concentration used: yes; constant volume of 2.80 mL/kg
- For solids, paste formed: yes
- Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5/sex
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: shortly after test substance administration, at frequent intervals for the remainder of Day 1, and twice daily thereafter.
- Frequency of weighing: Days 1 (day of dosing), 8, and 15
- Necropsy of survivors performed: yes - Statistics:
- No statistical analyses were reported
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- No deaths were reported.
- Clinical signs:
- other: No clinical signs were reported.
- Gross pathology:
- Gross pathology findings were normal.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- LD50 >2000 mg/kg
- Executive summary:
The test substance was suspended in water and applied to the clipped backs of male and female rats with an occlusive dressing at a dose of 2000 mg/kg of body weight. After 24 hours, the test substance was removed, and the animals were observed for 14 days. There were no deaths or other clinical signs of toxicity during the observation period. The animals gained weight normally. At necropsy, there were no abnormal findings. The acute lethal dermal dose of the test substance was found to be greater than 2000 mg/kg of body weight.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Additional information
In the rat, the substance has low acute oral (LD50 >5000 mg/kg) and dermal (LD50 >2000 mg/kg) toxicity.
Justification for classification or non-classification
Based on the acute oral LD50 in the rat (>5000 mg/kg) and the dermal LD50 in the rat (>2000 mg/kg) the substance does not need to be classified for acute toxicity according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
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.