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EC number: 208-293-9 | CAS number: 520-45-6
- 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
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Toxicity to reproduction
Administrative data
- Endpoint:
- screening for reproductive / developmental toxicity
- Remarks:
- Study is essentially a developmental toxicity study but has a postnatal development phase.
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Crica 1988
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 988
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Version / remarks:
- Essentially a developmental toxicity study but with a number females allowed to deliver their offspring and their postnatal growth and development monitored.
- Principles of method if other than guideline:
- Essentially a developmental toxicity study but with a number females allowed to deliver their offspring and their postnatal growth and development monitored.
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- Sodium 1-(3,4-dihydro-6-methyl-2,4-dioxo-2H-pyran-3-ylidene)ethanolate
- EC Number:
- 224-580-1
- EC Name:
- Sodium 1-(3,4-dihydro-6-methyl-2,4-dioxo-2H-pyran-3-ylidene)ethanolate
- Cas Number:
- 4418-26-2
- Molecular formula:
- C8H7O4.Na
- IUPAC Name:
- sodium 1-(6-methyl-2,4-dioxo-2H-pyran-3(4H)-ylidene)ethanolate
Constituent 1
- Specific details on test material used for the study:
- Dihydroacetic acid sodium salt (DHA-Na) referred to as sodium dehydroacetate in the publication.
Test animals
- Species:
- rat
- Strain:
- Wistar
- Details on test animals or test system and environmental conditions:
- Wistar rats (Japanese Rat), 12 to 13 weeks old. Cohabitated nulliparous females and males were paired overnight to achieve conception. For females presenting with sperm on the vaginal smear on the following morning for the experiment this was designated as gestation day 0 (GD 0). The females were housed in individual aluminium pregnancy cages (manufactured by Natsume Seisakusho Co., Ltd.), and were allowed free access to solid feed (Oriental Yeast Co., Ltd., MF) and tap water. The animal rearing laboratory was kept at 25 ± 1oC, 55 ± 5% relative humidity, ventilated 15 times/hr. and under a 12 hours of light regimen (6:00 to 18:00).
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- Gestation days (GD) 6 to 17.
- Details on mating procedure:
- Cohabitated nulliparous females and males overnight to achieve conception.
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- Gestation days (GD) 6 to 17.
- Frequency of treatment:
- Daily Gestation days (GD) 6 to 17.
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Remarks:
- Control
- Dose / conc.:
- 25 mg/kg bw/day (nominal)
- Dose / conc.:
- 50 mg/kg bw/day (nominal)
- Dose / conc.:
- 100 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 22-13
- Control animals:
- yes, concurrent vehicle
- Positive control:
- No
Examinations
- Parental animals: Observations and examinations:
- Clinical observations, body weight, food consumption.
- Oestrous cyclicity (parental animals):
- Not examined.
- Sperm parameters (parental animals):
- Not examined.
- Litter observations:
- From day of birth to 10 weeks of age of the offspring. Clinical observations, body weight.
- Postmortem examinations (parental animals):
- Necropsy, macroscopic examination.
- Postmortem examinations (offspring):
- Necropsy, macroscopic examination, organ weights.
- Statistics:
- Dams were considered to be the the unit of evaluation for the experimental results; Chi square-tests, t-tests and signed rank sum tests, results compared to the control group; hazard ratios of 5% and 1% were considered significant.
- Reproductive indices:
- Not specified.
- Offspring viability indices:
- Not specified, but offspring viability findings are clearly indicated by the data.
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- Piloerection at 100 mg/kg bw/day from GD 9. Not observed on GD 20.
- Dermal irritation (if dermal study):
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- At 100 mg/kg bw/day: significantly reduced at GD 15, 18 and 20. See tabulated data attached. See tabulated data attached.
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- At 100 mg/kg bw/day: significantly reduced at GD 12, 15 and 18. See tabulated data attached.
At 50 mg/kg bw/day: tansistory reduction at GD 12 and 18 - not reduced GD 15 or 20. See tabulated data attached. - Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- no effects observed
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- not specified
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not examined
- Reproductive function: sperm measures:
- not examined
- Reproductive performance:
- no effects observed
Effect levels (P0)
open allclose all
- Dose descriptor:
- LOAEL
- Effect level:
- ca. 100 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- body weight and weight gain
- food consumption and compound intake
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 50 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: : No significant maternal or embryo-fetal toxicity at 50 mg/kg bw/day.
Target system / organ toxicity (P0)
- Critical effects observed:
- not specified
Results: P1 (second parental generation)
General toxicity (P1)
- Mortality:
- not examined
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- no effects observed
- Dermal irritation (if dermal study):
- no effects observed
- Mortality / viability:
- mortality observed, non-treatment-related
- Description (incidence and severity):
- See tabulated data attached.
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- See tabulated data attached.
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Sexual maturation:
- no effects observed
- Description (incidence and severity):
- The offspring were weighed weekly and examined daily for 10 weeks, no observations were made regarding abnormal sexual development.
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Description (incidence and severity):
- See tabulated data attached.
- Gross pathological findings:
- no effects observed
- Histopathological findings:
- not examined
Developmental neurotoxicity (F1)
- Behaviour (functional findings):
- no effects observed
Developmental immunotoxicity (F1)
- Developmental immunotoxicity:
- not examined
Effect levels (F1)
- Key result
- Dose descriptor:
- NOEL
- Generation:
- F1
- Effect level:
- >= 100 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: : No significant embryo-fetal or F1 offspring toxicity at 100 mg/kg bw/day.
Overall reproductive toxicity
- Key result
- Reproductive effects observed:
- no
Any other information on results incl. tables
See tabulated data attached.
Applicant's summary and conclusion
- Conclusions:
- At 100 mg/kg bw/day: Maternal toxicity was evident as reduced food intake and body weight performance (there were also some changes in food intake at 50 mg/kg bw/day). Additionally, in the females killed at GD 20, for examination of their uterine content, early resorptions were higher and late resorptions marginally high. Fetal body weight was also low and decreased ossification was observed for some skeletal elements. There were no other treatment related effects at this dosage.
DHA-Na was not teratogenic.
For the parental (P0) females, that gave birth naturally, and their progeny, no treatment related effects were seen at any treatment level. All litters developed normally as expected until 10 weeks postpartum when the study was terminated. In utero treatment with DHA-Na up to 100 mg/kg bw/day was without effect on the F1 progeny. - Executive summary:
Groups of 22-23 female rats were treated with DHA-Na at 0, 25, 50 or 100 mg/kg bw/day throughout gestation (GD 6 -17). 16-17 females were selected for uterine exanimation at GD 20 and the remaining females were allowed to give birth naturally and raise their litters. The F1 offspring remained on study for 10 weeks.
At 100 mg/kg bw/day: Maternal toxicity was evident as reduced food intake and body weight performance (there were also some changes in food intake ay 50 mg/kg bw/day). Additionally, in the females killed at GD 20, for examination of their uterine content, early resorptions were higher and late resorptions marginally high. Fetal body weight was also low and decreased ossification was observed for some skeletal elements. There were no other treatment related effects at this dosage.
DHA-Na was not teratogenic.
For the parental (P0) females, that gave birth naturally, and their progeny, no treatment related effects were seen at any treatment level. All litters developed normally as expected until 10 weeks postpartum when the study was terminated. In utero treatment with DHA-Na up to 100 mg/kg bw/day was without effect on the F1 progeny.
The effects seen on the fetuses at 100 mg/kg bw/day (and to a lesser extent at 50 mg/kg bw/day) were most likely because of maternal toxicity. This was further illustrated by the females that were allowed to litter, where the F1 offspring survival and development were unaffected by treatment.
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