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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 252-351-6 | CAS number: 35081-45-9
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 2011
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The test item was administered by gavage to three groups, each of three male and three female Sprague-Dawley Crl:CD® (SD) IGS BR strain rats, for seven consecutive days, at dose levels of 150, 300 and 1000 mg/kg bw/day. A control group of three males and three females was dosed with vehicle alone (Polyethylene glycol 400).
Clinical signs, body weight change, dietary intake and water consumption were monitored during the study. Haematology, blood chemistry and organ weight data were evaluated at the end of the study and all animals were subjected to a gross necropsy examination. Histopathological examination of selected tissues was also performed. - GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 4'-benzyloxy-2-bromopropiophenone
- EC Number:
- 252-351-6
- EC Name:
- 4'-benzyloxy-2-bromopropiophenone
- Cas Number:
- 35081-45-9
- Molecular formula:
- C16H15BrO2
- IUPAC Name:
- 1-[4-(benzyloxy)phenyl]-2-bromopropan-1-one
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Duration of treatment / exposure:
- Period of seven consecutive days.
Doses / concentrationsopen allclose all
- Dose / conc.:
- 150 mg/kg bw/day (nominal)
- Dose / conc.:
- 300 mg/kg bw/day (nominal)
- Dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 1 Group:3 Female rats/ 3 Male rats - 150 mg/kg bw/day
2 Group:3 Female rats/ 3 Male rats - 300 mg/kg bw/day
3 Group:3 Female rats/ 3 Male rats - 1000 mg/kg bw/day
Control Group:3 Female rats/ 3 Male rats - Vehicle - Control animals:
- yes, concurrent vehicle
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- Clinical signs were mainly confined to the presence of post-dose increased salivation at all dose levels. One male treated at 1000 mg/kg bw/day showed clinical signs of ptosis, lethargy, hunched posture and respiratory pattern changes.
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Reduced dietary intake and reduced body weight gains and actual body weight losses were also evident for males from all treatment groups.
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- Reduced dietary intake was evident for males from all treatment groups when compared to controls and food efficiency (the ratio of body weight gain to dietary intake) was similarly reduced.
- Food efficiency:
- effects observed, treatment-related
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Haematological findings:
- no effects observed
- Description (incidence and severity):
- No toxicologically significant effects were detected on the haematological parameters investigated.
- Clinical biochemistry findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Blood chemical assessments showed increases in ALAT and ASAT when compared to controls for males treated with 1000 and 300 mg/kg bw/day. Slight reductions in A/G ratio and albumin levels were also evident for high dose males, together with increases in total protein levels.
Effect levels
- Dose descriptor:
- NOEL
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- clinical signs
- food consumption and compound intake
- gross pathology
- haematology
- histopathology: neoplastic
- histopathology: non-neoplastic
- mortality
- organ weights and organ / body weight ratios
- water consumption and compound intake
- Remarks on result:
- not determinable
Any other information on results incl. tables
The administration of TSE-1 by oral gavage for seven consecutive days at dose levels of 150, 300 and 1000 mg/kg bw/day resulted in treatment-related changes at all dose levels.
Clinical signs were mainly confined to the presence of post-dose increased salivation at all dose levels. One male treated at 1000 mg/kg bw/day showed clinical signs of ptosis, lethargy, hunched posture and respiratory pattern changes. Reduced dietary intake and reduced body weight gains and actual body weight losses were also evident for males from all treatment groups. These findings may have been suggestive of irritancy; however, histopathological examinations did not reveal any treatment-related gastric changes to support this.
Blood chemical assessments showed increases in ALAT and ASAT when compared to controls for males treated with 1000 and 300 mg/kg bw/day. Slight reductions in A/G ratio and albumin levels were also evident for high dose males, together with increases in total protein levels.
No treatment-related macroscopic abnormalities were recorded at termination, although elevated liver weights were evident for females from all treatment groups. The most noticeable finding on this study was the presence of pericholangitis (inflammation around the bile ducts) for animals from all treatment groups, suggestive of hepatotoxicity at all dose levels.
Based on the histopathological findings observed in this study, a ‘No Observed Effect Level’ (NOEL) or ‘No Observed Adverse Effect Level’ (NOAEL) could not be established.
Applicant's summary and conclusion
- Conclusions:
- The oral administration of TSE-1 to rats by gavage for a period of seven consecutive days at dose levels of 150, 300 and 1000 mg/kg bw/day resulted in treatment-related effects at all dose levels. Hepatotoxicity was evident at all dose levels, therefore a ‘No Observed Effect Level’ (NOEL) or ‘No Observed Adverse Effect Level’ (NOAEL) could not be established for this study.
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.