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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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- no data
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: peer reviewed published data, NTP study
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 979
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: NTP study
- Principles of method if other than guideline:
- NTP
Dose range finding study for carcinogenicity assay
7 weeks treatment + 1 week observation - GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Piperonyl butoxide
- IUPAC Name:
- Piperonyl butoxide
- Details on test material:
- PBO technical grade
Lot No 5
piperonyl butoxide, 88.4%
Niagara Chemical Company FMC, Middleport, new York, USA
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Frederick Cancer Research Center
- Age at study initiation: 4 weeks
- Weight at study initiation: 80-105 g
- Fasting period before study: not applicable
- Housing:
- Diet ad libitum
- Water ad libitum
- Acclimation period: 2 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22-24
- Humidity (%): 45-55
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light):12/12
IN-LIFE DATES: From: To: no data
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- other: with feed
- Details on oral exposure:
- Test diets containing piperonyl butoxide were prepared fresh each
week in 6- to 12-kilogram batches at appropriate doses. A known
weight of the chemical was first mixed with an equal weight of
autoclaved Wayne® Sterilizable Lab Meal (Allied Mills, Inc.,
Chicago, 111.), using a mortar and pestle. The mixing was
repeated with second and third additions of feed, and final
mixing was performed with the remaining quantity of feed for a
minimum of 15 minutes in a Patterson-Kelly twin-shell blender.
The diets were stored at 7 C in plastic bags during the 1 to
1-1/2 weeks it was used. - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 7 weeks + 1 week additional observation
- Frequency of treatment:
- daily
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
0, 1.47%, 2.15%, 3.15%, 4.6%, 6.8%
Basis:
nominal in diet
- Remarks:
- Doses / Concentrations:
0, 1323, 1935, 2835, 4140, 6120 mg/kg bw/day
Basis:
other: calculated using a factor 0f 0.09 mg/kg bw/d/ ppm
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, plain diet
- Details on study design:
- no data
- Positive control:
- not applicable
Examinations
- Observations and examinations performed and frequency:
- Daily observation for mortality
Clinicla signs,
body weight: twice per week
Food and water consumption on days 4, 11, 18, 39 for 6 rats per group - Sacrifice and pathology:
- organ weights and relative organe weights determined for:
liver, brain, heart, kidney, spleen, lung, testis, prostate, adrenal, thymus, ovary, uterus - Other examinations:
- Haematological and clinical chemical examinations
Histological examinations of liver and kidney
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- All animals died at the highest dose level; 4 males and 3 female sdied at the 4.6% dose level, no moratlites at 1.47-3.31%
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- All animals died at the highest dose level; 4 males and 3 female sdied at the 4.6% dose level, no moratlites at 1.47-3.31%
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- No effect at 1.47%, reduced body weight at higher dose levesl.
- 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 examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 14 700 ppm
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: body weight, histopathological findings
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Mortality and body weight
Dose | Males | Mean bw at week 7 | Females | Mean bw at week 7 | ||
% | Mortality | % of control | Mortality | % of control | ||
1.47 | 0/5 | 94 | 0/5 | 95 | ||
2.15 | 0/5 | 73 | 0/5 | 76 | ||
3.15 | 0/5 | 60 | 0/5 | 68 | ||
4.6 | 4/5 | 60 | 3/5 | 38 | ||
6.8 | 5/5 | n/a | 5/5 | n/a |
Applicant's summary and conclusion
- Conclusions:
- In this dose range finding study the NOAEL.was at lowest dose level at 14700 ppm (corresponding to calculated 1935 mg/kg bw/day).
MTD calculated were 10000 ppm which was employed in a subsequent carcinogenicity study in rats. - Executive summary:
Groups of 5 male and 5 female rats were administered PBO at levels 14700, 21500, 31500, 46000, and 68000 ppm included in the diet. groups of five control animals of each sex were administered a basal diet only. Calculated daily dose levels were 1323, 1935, 2835, 4140, 6120 mg/kg bw/day.
The period of administration of the test chemical was 7 weeks, followed by 1 week of additional observation. Each animal was weighed twice per week At the end of the subchronic studies, all animals were killed by CO2- inhalation and necropsied. The lowest doses at which clinical and histopathologic findings were observed were 21,500 ppm in the male and female rats thus a NOAEL of 14700 ppm was identified. (1323 mg/kg bw/day).
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