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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
Toxicity to reproduction
Administrative data
- 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
Cross-reference
- Reason / purpose for cross-reference:
- reference to other study
Reference
- 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.
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.
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- 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
Test material
- Reference substance name:
- Benzophenone
- EC Number:
- 204-337-6
- EC Name:
- Benzophenone
- Cas Number:
- 119-61-9
- Molecular formula:
- C13H10O
- IUPAC Name:
- benzophenone
1
- 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
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
Administration / exposure
- 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
Examinations
- 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.
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- 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 / performance (P0)
- Reproductive function: oestrous cycle:
- no effects observed
- Reproductive function: sperm measures:
- no effects observed
- Reproductive performance:
- no effects observed
Effect levels (P0)
open allclose all
- 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
Results: P1 (second parental generation)
Reproductive function / performance (P1)
- Reproductive function: oestrous cycle:
- no effects observed
- Reproductive function: sperm measures:
- no effects observed
- Reproductive performance:
- no effects observed
Details on results (P1)
Results: F1 generation
General toxicity (F1)
- 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
Effect levels (F1)
- 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
Results: F2 generation
Effect levels (F2)
- 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
Overall reproductive toxicity
- Key result
- Reproductive effects observed:
- no
Applicant's summary and conclusion
- 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.
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