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EC number: 210-288-1 | CAS number: 611-99-4
- 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
There is no repeat dose toxicity data available for this substance. The substance benzophenone (BP), which is the parent molecule for the di hydroxy species 4,4 -dihydroxybenzophenone, is used widely in personal care products and has been evaluated for both toxicology and ecotoxicology. It has been assessed that in the absence of other spcific data on 4,4 -dihydroxybenzophenone that benzophenone can be used as a suitable surrogate molecule for evaluation of this end point.
EFSA conducted a study "SCIENTIFIC OPINION Toxicological evaluation of benzophenone" (Scientific Opinion of the Panel on food contact materials, enzymes, flavourings and processing aids (CEF) May 2009.
The purpose was to re-assess the TDI (Tolerable Daily Intake) of benzophenone and hydroxybenzophenone since these materials can be used in food packaging and can migrate through packaging into the food and hence into humans by consumption.
Based on all available toxicity data carried out up to end May 2009 they concluded that based on the negative in vitro and in vivo results from tests with definite protocols the Panel concluded that benzophenone has no genotoxic potential. Liver and kidney were identified as the primary target organs of benzophenone toxicity in rats and mice. However, in a chronic carcinogenicity study in rats benzophenone did not cause liver tumours, even at exposure levels yielding severe liver damage. Therefore the Panel considers that the liver hypertrophy seen in rat is an adaptive response and not an adverse response.Thus, EFSA derived a LOAEL of 6 mg benzophenone/kg b.w. per day from this study. The TDI of 0.03 mg/kg b.w. per day for benzophenone consumption in humans has been set based on all relevant data
On the basis that this review has considered all the oral toxicological data studies for benzophenone and considered this level to be safe for daily human consumption.
In addition, the substance 4,4 -dihydroxybenzophenone sole use for this registration is that of a monomer in the manufacture of a PEK polymer. Residual monomr in the plastic is negligable. The only exposure to this substance would be in the manufacturing process and this is carried out under carefully controlled conditions so exposure will be minimal. Further animal testing can not be justifed
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: oral
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
- Justification for type of information:
- EFSA conducted a study "SCIENTIFIC OPINION Toxicological evaluation of benzophenone" (Scientific Opinion of the Panel on food contact materials, enzymes, flavourings and processing aids (CEF)
Question N° EFSA-Q-2009-411 Adopted on 14 May 2009. The purpose was to re-assess the TDI (Tolerable Daily Intake) of benzophenone and hydroxybenzophenone since these materials are used in food packaging and can migrate through packaging into the food and hence into humans by consumption.
Based on all available toxicity data carried out up to end May 2009 they concluded that based on the negative in vitro and in vivo results from tests with definite protocols the
Panel concluded that benzophenone has no genotoxic potential. Liver and kidney were identified as the primary target organs of benzophenone toxicity in rats and mice. However, in a chronic carcinogenicity study in rats benzophenone did not cause liver tumours, even at exposure levels yielding severe liver damage. Therefore the Panel considers that the liver hypertrophy seen in rat is an
adaptive response and not an adverse response.Thus, EFSA derived a LOAEL of 6 mg benzophenone/kg b.w. per day from this study. The TDI of 0.03 mg/kg b.w. per day for benzophenone consumption in humans has been set based on all relevant data
On the basis that this review has considered all the oral toxicological data studies for benzophenone and considered this level to be safe for daily himan consumption, further animal testing can not be justifed. - Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- Version / remarks:
- Details of the methodology are not given in the review. Test was for 90 days on rats
- Deviations:
- not specified
- Principles of method if other than guideline:
- Benzophenone-1, fed to 40 rats at doses of 0, 0.19, 0.6, 1.9 g/kg for 90 days. Exact details are no given in the report.
- GLP compliance:
- not specified
- Remarks:
- Data produced prior to GLP requiements being required.
- Species:
- rat
- Strain:
- other: Albino
- Sex:
- not specified
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Duration of treatment / exposure:
- 90 days
- Frequency of treatment:
- Daily
- Sacrifice and pathology:
- Depressed growth, liver and kidney lesions at 0.6 and 1.9 g/kg
- Mortality:
- no mortality observed
- Dose descriptor:
- NOEL
- Effect level:
- 0.19 other: g/kg
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- body weight and weight gain
- clinical signs
- Critical effects observed:
- yes
- Lowest effective dose / conc.:
- 0.6 other: g/kg
- System:
- urinary
- Organ:
- kidney
- liver
- Treatment related:
- not specified
- Conclusions:
- Benzophenone-1, fed to 40 rats at doses of 0 - l .9 g/kg for 90 days, produced depressed growth and liver and kidney lesions in animals at doses of 0.6 and 1.9 g/kg.
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 90 days
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- Version / remarks:
- Method not specified in the review document
- Deviations:
- not specified
- Principles of method if other than guideline:
- Benzophenone (FEMA No. 2134; CAS No. 119-61-9) was administered in the diet to rats at target dose levels of 20 mg/kg body weight/day for 90 days and 100 or 500 mg/kg/day for 28 days. Body weights and food consumption were measured weekly; haematology, clinical chemistry and urinalysis values were obtained at 4 wk and at the end of the study. Gross and microscopic pathological examinations were conducted and organ weights were recorded
- GLP compliance:
- not specified
- Remarks:
- Study carried out in 1991 by Burdock et al in the USA. GLP compliance is not specified inthe abstract.
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Administration was started at the age of 6 weeks for a period of 90 days
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Duration of treatment / exposure:
- 90 days
- Frequency of treatment:
- Daily
- Dose / conc.:
- 0 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 20 mg/kg bw/day (actual dose received)
- Observations and examinations performed and frequency:
- Body weights and food consumption were measured weekly; haematology, clinical chemistry and urinalysis values were obtained at 4 wk and at the end of the study. Gross and microscopic pathological examinations were conducted and organ weights were recorded
- Dose descriptor:
- NOEL
- Effect level:
- > 20 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- clinical signs
- Critical effects observed:
- no
- Conclusions:
- A no-effect level was demonstrated at 20 mg/kg/day for 90 days of administration. This would be equivalent to an intake of 1200 mg/day for a 60-kg human.
For the 28 day study, some changes in the blood make-up and increased liver and kidney weight were observied in the 100 mgkg/day and 500 mg/kg/day groups.
Referenceopen allclose all
The study detailed here are the results for the 90 day study.
In the same study, the authors carried out a 28 day study at the same time. They used 100 or 500 mg/kg/day on SD mixed sex rats for 28 days.
Body weights and food consumption were measured weekly; haematology, clinical chemistry and urinalysis values were obtained at 4 wk and at the end of the study. Gross and microscopic pathological examinations were conducted and organ weights were recorded.
Treatment-related changes resulted in decreases in red blood cell count and haematocrit, increases in urea nitrogen, bilirubin, total protein and albumin, increases in liver and kidney weights and hypertrophy of liver cells in the 100 and 500 mg/kg/day groups.
Decreases in haemoglobin and alkaline phosphatase and increase in glucose in 500 mg/kg/day group.
Additional information
Justification for classification or non-classification
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.
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