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EC number: 947-368-7 | 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:
- 11 September 2017 - 09 October 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
- Version / remarks:
- Most recent version
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- Benzyltriphenylphosphonium, salt with 4,4'- [2,2,2- trifluoro-1- (trifluoromethyl)ethylidene]bis[phenol] (1:1)
- Cas Number:
- 75768-65-9
- IUPAC Name:
- Benzyltriphenylphosphonium, salt with 4,4'- [2,2,2- trifluoro-1- (trifluoromethyl)ethylidene]bis[phenol] (1:1)
- Test material form:
- solid
- Details on test material:
- Purity: 98 %
Constituent 1
- Specific details on test material used for the study:
- Purity: > 98%
Test animals
- Species:
- rat
- Strain:
- other: Crl:CD (SD)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- - Source: Charles River Laboratories, Inc., Raleigh, NC
- Age at study initiation: Young adult animals (approx. 6-8 weeks old)
- Weight at study initiation: 140 g - 181 g
- Fasting period before study: Overnight
- Housing: Individually in wire mesh cages
- Diet: Free access to PMI Nutrition International, LLC, Certified Rodent LabDiet® 5002 (meal)
- Water: Free access to municipal water.
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.2 – 22.5
- Humidity (%): 39.3 - 54.4
- Air changes (per hr): a minimum of 10
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 12 September 2017 to 09 October 2017
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- methylcellulose
- Remarks:
- 0.5% in deionized water
- Details on oral exposure:
- FREQUENCY: single dosage, on Day 0.
VEHICLE: 0.5% methylcellulose (400 cps) in deionized water.
MAXIMUM DOSE VOLUME APPLIED:
10 mL/kg body weight.
DOSAGE PREPARATION:
The test substance formulations were prepared on each day of dosing as single formulations for each dose level. The test substance formulations were stirred continuously throughout the preparation and dose administration procedures. - Doses:
- 175 mg/kg body weight
550 mg/kg body weight
2000 mg/kg body weight - No. of animals per sex per dose:
- 175 mg/kg body weight (1 female rat)
550 mg/kg body weight (1 female rat)
2000 mg/kg body weight (1 and 2 female rats dosed in a stepwise manner) - Control animals:
- no
- Details on study design:
- STUDY DESIGN:
The test substance was administered once orally via gavage to 1 fasted female albino rat at a dose level of 175 mg/kg body weight, as no mortality was observed. Another female rat was dosed at 550 mg/kg body weight, as no mortality was observed. A third female rat was dosed at 2000 mg/kg body weight, as no mortality was observed. 2 additional female rats were dosed at 2000 mg/kg body weight.
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Mortality/Viability: Twice daily
Body weights: At study day 0, 7, and 14
Clinical signs: The rats were observed at the time of dosing, approximately 15 ± 5 minutes and 1, 2, and 4 hours post dosing on study day 0, and once daily thereafter for 14 days.
- Necropsy of survivors performed: All rats were euthanized by carbon dioxide inhalation. The major organ systems of the cranial, thoracic, and abdominal cavities were examined for all animals.
- Other examinations performed: none. - Statistics:
- No statistical analysis was performed.
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred.
- Clinical signs:
- other: Clinical signs observed in all animals were mucoid or soft feces and/or brown material around the anogenital area at approximately 4 hours following dose administration. One animal in dose group 2000 mg/kg bodyweight showed brown material around the anoge
- Gross pathology:
- There were no macroscopic findings at the necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In an acute oral toxicity study with rats performed according to OECD test guideline 425 and GLP principles, an LD50 > 2000 mg/kg body weight was determined. According to GHS criteria the substance does not need be classified.
- Executive summary:
An acute oral toxicity study was performed in female rats according to OECD test guideline 425 and GLP principles. The doses applied were 175 mg/kg body weight (1 female), subsequently 550 mg/kg body weight (1 female), then 2000 mg/kg body weight, (1 female and 2 female in a stepwise manner). No mortality occurred in all doses. Clincal observations were mucoid or soft feces and/or brown material around the anogenital area at approximately 4 hours following dose administration in all animals. One animal in the highest dose group showed brown material around the anogenital area on study days 1 and 2. There were no remarkable body weight changes noted during the study and there were no macroscopic findings at necropsy. Based on the results of this study, the estimated LD50 of BTPP:BPA salt was > 2000 mg/kg body weight and therefore BTPP:BPA salt does not have to be classified according to GHS criteria.
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