Registration Dossier
Registration Dossier
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: 947-162-7 | 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

Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Version / remarks:
- 2001
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.31 (Prenatal Developmental Toxicity Study)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.3700 (Prenatal Developmental Toxicity Study)
- Version / remarks:
- 1998
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- no
Test material
- Reference substance name:
- Tetraphenylphosphonium phenolate
- EC Number:
- 239-480-3
- EC Name:
- Tetraphenylphosphonium phenolate
- Cas Number:
- 15464-47-8
- Molecular formula:
- C24H20P.C6H5O
- IUPAC Name:
- tetraphenylphosphanium benzenolate
- Reference substance name:
- Phenol
- EC Number:
- 203-632-7
- EC Name:
- Phenol
- Cas Number:
- 108-95-2
- Molecular formula:
- C6H6O
- IUPAC Name:
- phenol
- Test material form:
- solid: crystalline
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature
- Stability under test conditions: analytically confirmed
- Homogeneity and stability of the test substance in the solvent/vehicle: analytically confirmed
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: none
Test animals
- Species:
- rat
- Strain:
- Wistar
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Strain: Hsd Cpb:WU (SPF-bred)
- Source: Harlan-Winkelmann GmbH, 33178 Borchen, Germany
- Acclimation period: at least 7 days prior to mating
- Body weight of animals at the time of mating: 386-438 g for males, 216-254 g for females
- Age at the day of mating: 15-17 weeks
- Housing: individually in Makrolon cages (MIII type)
- Diet and water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1
- Humidity (%): approximately 50
- Air changes (per hr): > 10
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From 2002-01-21 to experimental completion date (fetal visceral evaluation) on 2003-10-21
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Remarks:
- 400
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
- Fresh adminstration fromulations for each concentration were prepared daily.
VEHICLE
- vehicle: Polyethylene glycol 400
- Justification for use and choice of vehicle (if other than water): Based on trial formulations.
- Amount of vehicle (if gavage): 5 mL/kg bw
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Homogeneity and stability for at least 4 hours at room temperature was confirmed over the concentration range 0.2 to 270 mg/mL.
Accuracy of formulations was proven at two days during inlife phase. - Details on mating procedure:
- Animals were mated by placing two females overnight together with one male rat. If sperm count was detected in the vaginal smear taken on the morning following mating, this day was regarded as day 0 of gestation.
- Duration of treatment / exposure:
- Days 6 - 19 post-coitum, inclusive; fetuses were delivered by cesarean section on day 20 p.c.
- Frequency of treatment:
- Once daily
- Duration of test:
- from day 0 to necropsy at day 20 p.c.
Doses / concentrationsopen allclose all
- Dose / conc.:
- 10 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 40 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 160 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose:
- 27 pregnant females per dose
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: In order to set the dose levels for the main teratology study, a dose range finding study was performed. Four groups of 8 pregnant females were exposed to 0, 10, 40 and 160 mg/kg bw/day for Days 6 to 19 post-coitum inclusive by oral gavage.
Based on the results of the dose range finding study, selected dose levels for the main study were 10, 40 and 160 mg/kg bw/day.
Examinations
- Maternal examinations:
- CLINICAL EXAMINATIONS: Yes
- Time schedule: in general twice daily
BODY WEIGHT: Yes
- Time schedule for examinations: on day 0 pc and daily from day 6 to 20 pc
FOOD CONSUMPTION: Yes
- Days 0-3, 3-6, 6-9, 9-12, 12-15, 15-18 and 18-20 post-coitum.
WATER CONSUMPTION: Yes
- Once daily. Subjective appraisal was maintained during the study, but no quantitative investigation was introduced as no treatment related effect was suspected.
POST-MORTEM EXAMINATIONS: Yes
- All animals surviving to the end of the observation period and the animal showing premature delivery were sacrificed using cardiotomy under deep carbon dioxide anestesia. - Ovaries and uterine content:
- Each ovary and uterine horn of animals surviving to planned necropsy was dissected and examined as quickly as possible to determine:
- The number of corpora lutea.
- The weight of the (gravid) uterus.
- The number and distribution of live and dead fetuses.
- The number and distribution of embryo-fetal deaths (early and late resorptions).
- The weight of each fetus.
- The sex of each fetus from the ano-genital distance (during necropsy) and also from gonadal
inspections (during further fetal examination).
- Externally visible macroscopic fetal abnormalities. - Fetal examinations:
- External, visceral, and skeletal findings were recorded as developmental variations (alterations in anatomic structure that are considered to have no significant biological effect on animal health or body conformity and/or represent slight deviations from normal) or malformations (those structural anomalies that alter general body conformity, disrupt or interfere with normal body function, or may be incompatible with life).
- Statistics:
- yes
- Historical control data:
- yes, historical data on fetal morphology are part of the report
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- treatment resulted in increased incidences of salivation after administration at al dose levels, possibly a result of a bad taste or olfactory component of the test substance. For the reddish discolored salivation that was observed at 40 mg/kg bw and above a treatment related effect could not be excluded.
- Mortality:
- no mortality observed
- Description (incidence):
- two females in the control group and one female in the 160 mg group died/were sacrificed due to misapplication.
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- At 160 mg/kg bw body weight gain from days 6-19 pc was distinctly reduced compared to control animals (54.8 g versus 76.4 g).
Also the corrected body weight gain from days 0-20 was lower in 160 mg/kg bw animals than in control animals (19.2 g versus 46.7 g). - Description (incidence and severity):
- Food intake was reduced from start of treatment to the end of gestation at the 160 mg/kg bw dose level.
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- necropsy revealed no treatment related findings.
- Neuropathological findings:
- not examined
Maternal developmental toxicity
- Number of abortions:
- no effects observed
- Pre- and post-implantation loss:
- no effects observed
- Description (incidence and severity):
- At 60 mg/kg bw/day, a significant increase in pre-implantation loss was observed (12.2 % compared to 6.0 % in the control group). Treatment was started on Day 6 post-coitum, after implantation has occurred, therefore this finding is considered not to be related to treatment. Moreover, no dose response relationship was noted.
- Total litter losses by resorption:
- no effects observed
- Early or late resorptions:
- no effects observed
- Dead fetuses:
- no effects observed
- Changes in pregnancy duration:
- no effects observed
- Description (incidence and severity):
- Migrated Data from removed field(s)
Field "Effects on pregnancy duration" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsMaternalAnimals.MaternalDevelopmentalToxicity.EffectsOnPregnancyDuration): no effects observed - Changes in number of pregnant:
- no effects observed
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- 10 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Basis for effect level:
- other: reddish discolored salivation after administration at >= 40 mg/kg bw and distinctly reduced body weight and food consumption at 160 mg/kg bw
Maternal abnormalities
- Abnormalities:
- effects observed, treatment-related
- Localisation:
- other: general maternal toxicity
- Description (incidence and severity):
- very slight severity at 40 and 160 mg/kg bw
Results (fetuses)
- Fetal body weight changes:
- no effects observed
- Reduction in number of live offspring:
- no effects observed
- Changes in sex ratio:
- no effects observed
- Changes in litter size and weights:
- no effects observed
- Changes in postnatal survival:
- not examined
- External malformations:
- no effects observed
- Skeletal malformations:
- no effects observed
- Visceral malformations:
- no effects observed
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- 160 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no adverse effects at this dose
Fetal abnormalities
- Abnormalities:
- no effects observed
Overall developmental toxicity
- Developmental effects observed:
- no
Applicant's summary and conclusion
- Executive summary:
In a prenatal developmental toxicity study performed according to OECD TG 414 mated female Wistar rats were assigned to four dose groups, each containing twenty-seven animals. The test item was administered once daily by gavage from Day 6 to 19 post-coitum at doses of 10, 40 and 160 mg/kg bw/day. The animals were sacrificed on day 20 pc. The rats of the control group received the vehicle, Polyethylene glycol 400, alone.
With regard to maternal toxicity salivation occured in all treated animals. At 40 mg/kg bw and above reddish discolored salivation was observed that was considered as treatment related and adverse. At 160 mg/kg bw body weight development was distinctly impaired and food intake was reduced.
No further maternal toxicity or any developmental findings became obvious.
In conclusion and based on the results in this prenatal developmental toxicity study the maternal No Observed Adverse Effect Level (NOAEL) was established as being 10 mg/kg bw/day and the NOAEL for developmental toxicity was determined with 160 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.
