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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 241-698-9 | CAS number: 17696-62-7
- 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:
- 2018-01-03 to 2018-03-09
- 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 420 (Acute Oral Toxicity - Fixed Dose Method)
- Version / remarks:
- Adopted, 17th December, 2001
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Phenyl 4-hydroxybenzoate
- EC Number:
- 241-698-9
- EC Name:
- Phenyl 4-hydroxybenzoate
- Cas Number:
- 17696-62-7
- Molecular formula:
- C13H10O3
- IUPAC Name:
- phenyl 4-hydroxybenzoate
Constituent 1
- Specific details on test material used for the study:
- - Batch No.: 018964K19K
- CAS No.:17696-62-7
- Storage: room temperature
- Form: powder
- Expiry date: August 2018
- Colour: white
- Purity: 99.1%
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage JANVIER LABS (53940 Le Genest St Isle, France)
- Females (if applicable) nulliparous and non-pregnant: Yes
- Age at study initiation: 8 or 9 weeks
- Housing: Animals were housed by group of three in solid-bottomed clear polycarbonate cages with a stainless steel mesh lid. Each cage contains sawdust bedding which was changed at least 2 times a week.
- Diet (e.g. ad libitum): ad libitum, foodstuff ENVIGO - 2016; Food was removed on day 1 and then redistributed 4 hours after the test item administration.
- Water (e.g. ad libitum): ad libitum; tap water
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25
- Humidity (%): 30 - 70
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- DMSO
- Details on oral exposure:
- VEHICLE
- Amount of vehicle (if gavage): 5 mL in the first step and 10 mL in the second step
- Justification for choice of vehicle: Dimethyl sulfoxide (DMSO) was chosen as it produced the most suitable formulation at the requested concentrations.
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg body weight
DOSAGE PREPARATION (if unusual): In the first and second step of the study, 1.0007 g and 2.0003 g of the test item were weighed and DMSO was added to a 5 mL volumetric flask and to a 10 mL volumetric flask respectively. Just before the administration, the preparations were stirred by vortex to obtain yellowish solutions. - Doses:
- 2000 mg/kg body weight
- No. of animals per sex per dose:
- Control: 4 females
Treatment: 1 female rat (step 1); 4 female rats (step 2) - Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: 30 minutes, 1 hour, 3 hours, 4 hours, on day 1 and day 2 and during 14 days
- Frequency of weighing: day 0 (just before administering the test item) then on day 2, day 7, and day 14
- Necropsy of survivors performed: yes - Statistics:
- n.a.
Results and discussion
- Preliminary study:
- n.a.
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- One mortality was noted in animals treated at the dose of 2000 mg/kg body weight, at 48 hours post dose during the step 2.
- Clinical signs:
- other: In one animal, the mortality was preceded by an absence or a decrease of spontaneous activity, Preyer’s reflex, muscle tones, righting reflex associated with hypothermia, eyes partly closed and piloerection, at 24 hours post dose. In the surviving animals
- Gross pathology:
- The macroscopic examination of the mortal animal revealed black spots on the corpus. Rigor mortis was noted before the necropsy. No other changes were noted.
The macroscopic examination of the surviving animals at the end of the study did not reveal treatment related changes.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In an acute oral toxicity study in rats conducted according to OECD 420 one out of four female rat died at the limit dose of 2000 mg/kg bw at 48 hours post dose during the step 2. The LD50 value was determined to be greater than 2000 mg/kg bw.
- Executive summary:
In an acute oral toxicity study (fixed dose procedure, OECD 420), fasted, 8-9 weeks old female Wistar rats (1 at step 1 and 4 at step 2) were given a single oral dose of the test item (99.1% purity) in DMSO at the limit dose of 2000 mg/kg by gavage and were observed for 14 days. One animal died at 48 hours post dose during the step 2. The mortality was preceded by an absence or a decrease of spontaneous activity, Preyer’s reflex, muscle tones, righting reflex associated with hypothermia, eyes partly closed and piloerection, at 24 hours post dose. Rigor mortis was noted before the necropsy. The macroscopic examination of the animal revealed black spots on the corpus. No other change was noted. In the surviving animals an absence or a decrease in spontaneous activity (1/4) and righting reflex, associated with an increase of salivation were noted during the first hours of the test. The animal recovered a normal activity on day 2. The macroscopic examination of the animals at the end of the study did not reveal treatment related changes. Based on the results from this study, the oral LD50 in rats can considered to be greater than 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.