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Diss Factsheets
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EC number: 204-409-7 | CAS number: 120-57-0
- 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
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian germ cell study: cytogenicity / chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1972
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Study without detailed documentation; Oral gavage dose volume, purity not reported.
Data source
Reference
- Reference Type:
- publication
- Title:
- Detection of chemical mutagens by the dominant lethal assay in the mouse
- Author:
- Epstein S.S., Arnold E., Andrea J., Bass W., and Bishop Y
- Year:
- 1 972
- Bibliographic source:
- Toxicology and Applied Pharmacology 23, 288-325 (1972)
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 478 (Genetic Toxicology: Rodent Dominant Lethal Test)
- Deviations:
- yes
- Remarks:
- -Oral gavage dose volume, purity not reported.
- GLP compliance:
- no
- Remarks:
- Study pre-dates GLP.
- Type of assay:
- rodent dominant lethal assay
Test material
- Reference substance name:
- Piperonal
- EC Number:
- 204-409-7
- EC Name:
- Piperonal
- Cas Number:
- 120-57-0
- Molecular formula:
- C8H6O3
- IUPAC Name:
- 1,3-benzodioxole-5-carbaldehyde
- Test material form:
- not specified
- Details on test material:
- - Name of test material (as cited in study report): Heliotropine
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- other: ICR/Ha Swiss
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: males were 8-10 weeks old at the study initiation; females were 8-10 weeks old when mated
- Weight at study initiation: Not reported
- Assigned to test groups randomly: Not reported
- Fasting period before study: Not reported
- Housing: housed in suspended mesh caged in air-conditioned rooms with automated light-darkness cycles.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: Not reported
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not reported
- Humidity (%): Not reported
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): Not reported
Administration / exposure
- Route of administration:
- other: Oral gavage (daily for 5 days) or intraperitoneal (single dose).
- Vehicle:
- - Vehicle(s)/solvent(s) used: The study stated that agents under test were freshly prepared in triacprylin or distilled water for single administration to male mice by intraperitoneal injection or by gavage; however, it is unclear which vehicle was used in this study.
- Details on exposure:
- The study stated that agents under test were freshly prepared in triacprylin or distilled water for single administration to male mice by intraperitoneal(ip) injection or by gavage (further details were not reported). No details were available regarding the day(s) of dosing relative to start of mating periods.
- Duration of treatment / exposure:
- IP: Single administration
Oral gavage: Once per day for 5 successive days - Frequency of treatment:
- IP injection: Single administration
Oral gavage administration: Once per day for 5 successive days - Post exposure period:
- Each treated male was mated with 3 females per week for 8 weeks. Females were sacrificed 13 days after the midweek of their caging and presumptive mating, without being checked for vaginal plugs.
Doses / concentrationsopen allclose all
- Dose / conc.:
- 124 other: mg/kg
- Remarks:
- nominal conc.
IP injection for males only
- Dose / conc.:
- 620 other: mg/kg
- Remarks:
- nominal conc.
IP injection for males only
- Dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- Remarks:
- oral gavage administration for males only
- No. of animals per sex per dose:
- 124 mg/kg: 7 males per dose; 21 females per dose (each mated with 3 females per week for 8 weeks)
640, 1000 mg/kg: 9 males per dose; 27 females per dose (each mated with 3 females per week for 8 weeks)
Control group: 10 males; 30 females per dose (each mated with 3 females per week for 8 weeks) - Control animals:
- yes, concurrent vehicle
- Positive control(s):
- A total of 174 chemicals including, but not limited to, pharmaceuticals, food additives, and pesticides in the dominant lethal assay. Some substances, including acetylaminofluorene and benzoyl peroxide, produced positive results (and therefore can be considered positive controls by default).
Examinations
- Tissues and cell types examined:
- At autopsy, each female was scored for pregnancy, and for numbers of total implants and early fetal deaths were analyzed. Corpora lutea counts were omitted.
- Details of tissue and slide preparation:
- Information not reported
- Evaluation criteria:
- See below for information on evaluation criteria.
- Statistics:
- Analaysis of variance performed for the complete experiment and its replicates.
Results and discussion
Test results
- Key result
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- not examined
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- On the basis of these procedures, heliotropin was classified as a test agent meeting screening criteria but judged non-significant by analysis of variance. See Table 1.
Any other information on results incl. tables
Table 1. Agent producing early fetal deaths and/or pre-implantation losses beyond control limits but with differences not significant by analysis of variance |
||||||||
Agent |
Route and frequency of administration |
Total weeks of mating |
Dose (mg/kg) |
No. of males (No. of deaths) |
Parameters selected in screen (mating week) |
|||
% pregnancy |
Implants per pregnancy |
Early deaths per pregnancy |
% pregnant females with early deaths |
|||||
Heliotropine* |
IP |
8 |
124 |
7 |
- |
- |
- |
- |
|
|
|
620 |
9 |
- |
- |
1.80 (2) |
- |
|
|
8 |
124 |
7 |
20 (8) |
- |
- |
- |
|
|
|
620 |
9 |
19 (8) |
- |
1.00 (1) |
- |
|
Oral |
8 |
1000 |
9 |
- |
- |
- |
- |
*Compound meeting only less stringent screening criteria.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
Heliotropine (piperonal) produced early fetal deaths beyond control limits, but judged non-significant by analysis of variance and is therefore considered to be negative for genotoxicity. - Executive summary:
Compared with control values, oral administration of heliotropin (piperonal) for 5 consecutive days had no effect on the incidence of pregnancies, early fetal deaths, or pre-implantation losses at any of the timepoints evaluated. Intraperitoneal administration of heliotropin (piperonal) (620 mg/kg body weight) resulted in a slight increase in early fetal deaths only during the first or second week after dosing; this effect was not statistically significant relative to control values and was therefore considered not adverse or reflective of potential genotoxicity. Based on these findings, the no-observed-adverse-effect level (NOAEL) for this study can be considered to be an oral dose level of 1,000 mg/kg body weight/day.
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