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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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- publication
- Title:
- Developmental toxicity study of piperonyl butoxide in CD rats
- Author:
- Tanaka T, Fujitani T, Takahashi O, Oishi S, Yoneyama M.
- Year:
- 1 995
- Bibliographic source:
- Toxicol Ind Health 11, 175-184
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Principles of method if other than guideline:
- treatment only on gestation days 11 and 12
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Piperonyl butoxide
- IUPAC Name:
- Piperonyl butoxide
- Test material form:
- other: liquid
- Details on test material:
- Piperonyl butoxide (Lot No DZ01) from Tokyo Kasei Co, Ltd (Tokyo, Japan)
Purity >95%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Crj:CD
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Japan inc (Kanagawa, Japan)
- Age at study initiation: 8 weeks
- Weight at study initiation: no data
- Fasting period before study: no data
- Housing:
- Diet : ad libitum (nihon Clea, CE-2)
- Water: ad libitum):
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 24 ± 1 °C
- Humidity (%): 55 ± 5%
- Air changes (per hr): air conditioned
- Photoperiod (hrs dark / hrs light): no data
IN-LIFE DATES: From: To: no data
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- not applicable
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- test item was administered directly by gavage
- Details on mating procedure:
- no data
- Impregnation procedure: cohoused
- If cohoused:
- M/F ratio per cage: 1 male/ 2 females
- Length of cohabitation: over night
- Proof of pregnancy: vaginal plug / referred to as day 0 of pregnancy
- Any other deviations from standard protocol: none - Duration of treatment / exposure:
- day 11-12 of gestation
- Frequency of treatment:
- daily
- Duration of test:
- until caesarian on gestation day 20
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 630, 1065, 1800 mg/kg bw
Basis:
actual ingested
- No. of animals per sex per dose:
- 15 control mated females
10 mated females per treatment group - Control animals:
- other: saline by gavage
- Details on study design:
preliminary pilot studies to determine dose and timing of treatment
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: no data
DETAILED CLINICAL OBSERVATIONS:o data
BODY WEIGHT: Yes
- Time schedule for examinations: gestation days 11-20
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): No data
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day 20
- Organs examined: no data - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: No data
- Number of corpora lutea: No data
- Number of implantations: Yes
- Number of resorptions: Yes
- - Fetal examinations:
- - External examinations: Yes: all per litter
- Soft tissue examinations: No data
- Skeletal examinations: Yes: all per litter
- Head examinations: No data - Statistics:
- Bonferroni's multiple comparison test after ANOVA or Kruskal-Wallis-test
Chi-square test
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:yes
Details on maternal toxic effects:
No abnormal behaviour
No mortality
3/15 not pregant in control group
2 litters were totally resorbed at 1800 mg/kg bw/d
reduced bw gain (gestation day 11-20)
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 630 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- NOAEL
- Effect level:
- 630 mg/kg bw/day (actual dose received)
- Based on:
- act. ingr.
- Basis for effect level:
- other: developmental toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:yes
Details on embryotoxic / teratogenic effects:
The average fetal body weight of each sex was significantly reduced in the 1065 and 1800 mg/kg bw groups. External limb deformity (oligodactyly, syndactyly, and polydactyly) was significantly increased in the 1065 and 1800 mg/kg bw groups in a dose-related manner.
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
|
Dose level (mg/kg bw/day) |
|||
|
0 |
630 |
1065 |
1800 |
No of females examined |
15 |
10 |
10 |
10 |
No of pregnant females |
12 |
10 |
10 |
10 |
No of dams with viable fetuses |
12 |
10 |
10 |
8 |
Maternal body weight gain |
109 |
92.5 |
83.0 |
69.0** |
Total implantation sites |
179 |
142 |
142 |
153 |
Average implantation sites |
14.9 |
14.2 |
14.2 |
15.3 |
No of resorptions |
1 |
0 |
3 |
54 |
Total resorption rate (%) |
0.56 |
0 |
2.1 |
35.3** |
Number of viable fetuses |
178 |
142 |
139 |
99 |
Sex ratio(male/female) |
1.31 |
1.06 |
1.28 |
1.15 |
Average litter size |
14.8 |
14.2 |
13.9 |
12.4 |
Fetal body weight male(g) |
3.52 |
3.61 |
3.35 |
3.01** |
Fetal body weight (female) |
3.33 |
3.40 |
3.21 |
2.88** |
Proportion of fetuses with limb deformity (%) |
0 |
0 |
19.4** |
44.4** |
Applicant's summary and conclusion
- Conclusions:
- Developmental effects at maternally toxic dose levels. NOAEL for maternal and developmental toxicity was 630 mg/kg bw/day.
- Executive summary:
Piperonylbutoxide was administered to pregnant rats by gavage at a level of 0 (control), 630, 1065, and 1800 mg/kg bw on days 11-12 of gestation. The animals were killed on day 20 of gestation. Average maternal body weight gain (gestational days 11-20) was significantly reduced in the 1065 and 1800 mg/kg bw groups. Total resorption rate was significantly increased in the 1800 mg/kg bw group and those effects were significantly dose-related. The average fetal body weight of each sex was significantly reduced in the 1065 and 1800 mg/kg bw groups. External limb deformity (oligodactyly, syndactyly, and polydactyly) was significantly increased in the 1065 and 1800 mg/kg bw groups in a dose-related manner. The dose levels of piperonylbutoxide in the present study produced limb deformities in rats at maternally toxic dose levels only..
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