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Diss Factsheets
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EC number: 200-076-7 | CAS number: 51-03-6
- 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
Carcinogenicity
Administrative data
- Endpoint:
- carcinogenicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 1 (reliable without restriction)
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 979
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 451 (Carcinogenicity Studies)
- Deviations:
- yes
- Remarks:
- NTP study protocol
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Piperonyl butoxide
- IUPAC Name:
- Piperonyl butoxide
- Details on test material:
- PBO technical grade, 88.4%
Lor No 5
Niagara Chemical Company FMC, Middleport, new York, USA
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- other: feed
- Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- 107 weeks
- Frequency of treatment:
- daily
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
0, 5000 ppm, 10000 ppm
Basis:
analytical conc.
- Remarks:
- Doses / Concentrations:
0, 250, 500 mg/kg bw/day
Basis:
other: calculated
- No. of animals per sex per dose:
- 50
- Control animals:
- yes, plain diet
Examinations
- Statistics:
- Taone test for mortality
Cochran-Armitage test for positive dose-related trend in the incidence of lymphomas and Fisher exact test
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- reduced body weights at both treatment levels
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Relevance of carcinogenic effects / potential:
- In the female rats, lymphomas occurred at incidences that were dose related (P = 0.007); in a direct comparison, the incidence
of the tumor in the high-dose group was higher (P = 0.020) than that in the control group (controls 1/20, low-dose 7/50, high-dose 15/50). However, the incidence of lymphomas, leukemias, and reticuloses in historical-control female Fischer 344 rats at the same laboratory was 19/191 (10%). These historical-control groups include one with an incidence of animals with lymphoma or leukemia of 7/20 (35%) and another with an incidence of 6/20 (30%). Thus, the incidence of lymphomas in the control female rats of the present bioassay may have been abnormally low, and the occurrence of the higher incidence in the dosed groups cannot be clearly related to administration of piperonyl butoxide.
Effect levels
open allclose all
- Dose descriptor:
- LOAEL
- Effect level:
- 5 000 mg/kg diet
- Based on:
- act. ingr.
- Sex:
- male/female
- Basis for effect level:
- other: see 'Remark'
- Remarks on result:
- other: Effect type: toxicity (migrated information)
- Dose descriptor:
- NOAEL
- Effect level:
- 10 000 mg/kg diet
- Based on:
- act. ingr.
- Sex:
- male/female
- Basis for effect level:
- other: No carcinogenic effect observd
- Remarks on result:
- other: Effect type: carcinogenicity (migrated information)
Any other information on results incl. tables
Taone test for mortality
Cochran-Armitage test for positive dose-related trend in the incidence of lymphomas and Fisher exact test
Applicant's summary and conclusion
- Conclusions:
- It is concluded that under the conditions of this bioassay, piperonyl butoxide was not carcinogenic for Fischer 344 rats
- Executive summary:
Groups of 50 rats of each sex were administered piperonyl butoxide in the diet at one of two doses, either 5,000 or 10,000 ppm, for 107 weeks. Matched controls consisted of 20 untreated rats of each sex. All surviving rats were killed at the end of the period of administration of the test chemical.
Mean body weights of dosed groups of rats and mice of each sex were lower than those of corresponding control group, and the
depressions in body weights were dose related. Survival of the rats was unaffected by the piperonyl butoxide and was
80% or greater in all groups at week 90 of the bioassay; thus, sufficient numbers of dosed and control rats and mice of each sex
were at risk for the development of late-appearing tumors.
In the female rats, lymphomas occurred at incidences that were dose related (P = 0.007); in a direct comparison, the incidence
of the tumor in the high-dose group was higher (P = 0.020) than that in the control group (controls 1/20, low-dose 7/50, high-dose 15/50). However, the incidence of lymphomas, leukemias, and reticuloses in historical-control female Fischer 344 rats at the same laboratory was 19/191 (10%). These historical-control groups include one with an incidence of animals with lymphoma or leukemia of 7/20 (35%) and another with an incidence of 6/20 (30%). Thus, the incidence of lymphomas in the control female rats of the present bioassay may have been abnormally low, and the occurrence of the higher incidence in the dosed groups cannot be clearly related to administration of piperonyl butoxide.
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