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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
Key value for chemical safety assessment
Effects on fertility
Description of key information
There is no reproduction 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.
Regarding effects of BZP on the FO and F I parental animals in the present study, changes such as inhibition of body weight gain and food consumption, increase in renal weights and dilatation and regeneration of renal proximal tubules were recognized in the groups receiving 450 ppm or 2000 ppm, and increase in the hepatic weights and centrilobular hepatocytic hypertrophy were observed in the 100 ppm or higher groups.
With regard to reproductive toxicity in FO and Fl parental animals, there were no obvious effects even at the highest dose of 2000 ppm. As for effects on Fl and F2 offspring, inhibition of the body weight gain was observed at the dose of 2000 ppm.
Therefore, from the present study of BZP administered to rats over two-generations, the no observed effect level (NOEL) on the parental animals is concluded to be less than 100 ppm based on body weight and liver and kidney observation.
Concerning effects on the endocrine system and reproductive toxicity in parental animals, the NOEL is 2000 ppm.
In terms of the effects on the offspring, the NOEL is considered to be 450 ppm.
Reproductive toxicity was not observed in this study, effects on the offspring were observed at the highest dose only.
Link to relevant study records
- Endpoint:
- two-generation reproductive toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 416 (Two-Generation Reproduction Toxicity Study)
- Version / remarks:
- OECD 1983
- GLP compliance:
- not specified
- Remarks:
- Testing carried out in Japan in 2005 by Hoshino et al. Details not given in paper
- Specific details on test material used for the study:
- Details specified in publication by Hoshino et al, published in 2005, the summary of which is contained in the EFSA review paper.
Analytical purity: 99.98% or higher
- Lot/batch No.: 112D2013 - Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- Male and female Sprague-Dawley (SD) rats, parental (F0) and first generation (F1), were exposed to benzophenone by feeding diet with concentrations of 0 (control), 100, 450 or 2000 ppm (corresponding approximately to doses of 6-9, 29-40 and 130-179 mg/kg body weight/day, respectively) .
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- Administration of F0 parental animals started from an age of 5 weeks and continued in males for 10 weeks. For females, administration lasted through 10 weeks or more of the pre-mating, mating, gestational, lactational and during weaning of the F1 offspring (PND 21).
Administration to F1 parental animals was started from the time of weaning (three weeks old); in F1 males it was continued until necropsy trough 10 weeks or more of the pre-mating and mating periods, and in F1 females until necropsy through 10 weeks or more of the pre-mating, mating, gestational, lactational periods, and during weaning of the F2 offspring (PND 21). - Frequency of treatment:
- Daily through diet
- No. of animals per sex per dose:
- 24 of each sex
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- Dosing was based on the results of a preliminary dose-range finding study over 4 weeks with dietary concentrations of 0, 600, 2000, 6000 or 20000 ppm. The highest dose for the definite study was set at 2000 ppm
- Positive control:
- No
- Parental animals: Observations and examinations:
- In F0 and F1 parental animals, inhibition of body weight gain and food consumption, significantly elevated renal weights, dilatation of the renal proximal tubules, and regeneration of the proximal tubular epithelium were recognized at doses of 450 ppm and 2000 ppm, along with an increase in hepatic weight and centrilobular
hepatocytic hypertrophy.
Obvious effects on the endocrine system and reproductive toxicological effects were not observed up to the highest dose of 2000 ppm in the F0 or F1 parent animals (no test substance related changes in the estrous cycle, reproductive capability, delivery and lactation, sperm parameters, serum hormone levels, or necropsy findings). - Litter observations:
- Inhibition of body weight gain was observed in both the F1 and F2 males and females of the 2000 ppm group, but no other treatment-related effects were observed (in the number of male and female F1 or F2 pups delivered, viability, anogenital distance, physical development, the results of reflex and response tests, or on the observation results of external abnormalities)., where there was an increase in liver weight and centrilobular hypertrophy, and in kidney.
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- 100 ppm: hypertrophy of centrilobular hepatocytes in males and females
>= 450 ppm: dilation of renal proximal tubules in both males and females. - Reproductive function: oestrous cycle:
- no effects observed
- Reproductive function: sperm measures:
- no effects observed
- Reproductive performance:
- no effects observed
- Dose descriptor:
- NOEL
- Remarks:
- general clinical observations
- Effect level:
- < 100 ppm (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- organ weights and organ / body weight ratios
- histopathology: non-neoplastic
- Dose descriptor:
- NOEL
- Remarks:
- reproduction and endocrine system
- Effect level:
- > 2 000 ppm (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- reproductive function (oestrous cycle)
- reproductive function (sperm measures)
- reproductive performance
- Reproductive function: oestrous cycle:
- no effects observed
- Reproductive function: sperm measures:
- no effects observed
- Reproductive performance:
- no effects observed
- Clinical signs:
- no effects observed
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- inhibition of body weight gain was observed in both the F1 and F2 males and females of the 2000 ppm group
- Dose descriptor:
- NOEL
- Generation:
- F1
- Effect level:
- 450 ppm (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- Dose descriptor:
- NOEL
- Generation:
- F2
- Effect level:
- 450 ppm (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- Key result
- Reproductive effects observed:
- no
- Conclusions:
- Regarding effects of BZP on the FO and F I parental animals in the present study, changes such as inhibition of body weight gain and food consumption, increase in renal weights and dilatation and regeneration of renal proximal tubules were recognized in the groups receiving 450 ppm or 2000 ppm, and increase in the hepatic weights and centrilobular hepatocytic hypertrophy were observed in the 100 ppm or higher groups.
These changes were generally in line with the report of Burdock et al. (1991 When BZP was administered to rats at the dose of 20 mg/kg/day for 90 days or at the doses of 100 or 500 mg/kg/day for 28 days, inhibition of the body weight gain, increased relative liver and kidney weights and centrilobular hepatocyte hypertrophy were thus evident (Burdock et al., 1991) - see Repeat dose oral toxicity end point - woe2
Although there have been previous reports of potential effects of BZP on the endocrine system, only weak estrogenic, as well as weak antiestrogenic action was observed in uterotrophic assays (METI, 2002).
No adverse effects seemingly related to these actions were observed in this two-generation reproductive toxicity study. With regard to reproductive toxicity in FO and Fl parental animals, there were no obvious effects even at the highest dose of 2000 ppm.
As for effects on Fl and F2 offspring, inhibition of the body weight gain was observed at the dose of 2000 ppm.
Therefore, from the present study of BZP administered to rats over two-generations, the no observed effect level (NOEL) on the parental animals is concluded to be less than 100 ppm. Concerning effects on the endocrine system and reproductive toxicity in parental animals, the NOEL is 2000 ppm. In terms of the effects on the offspring, the NOEL is considered to be 450 ppm.
Reproductive toxicity was not observed in this study, effects on the offspring were observed at the highest dose only.
Reference
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Species:
- rat
Justification for classification or non-classification
Additional information
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