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EC number: 224-052-0 | CAS number: 4180-23-8
- 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

Endpoint summary
Administrative data
Key value for chemical safety assessment
- Toxic effect type:
- concentration-driven
Effects on fertility
Link to relevant study records
- Endpoint:
- two-generation reproductive toxicity
- Remarks:
- based on test guideline (migrated information)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 416 (Two-Generation Reproduction Toxicity Study)
- GLP compliance:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Route of administration:
- oral: feed
- Duration of treatment / exposure:
- F0:70 days
F1-F4: raised on treated diet - Remarks:
- Doses / Concentrations:
600-1500 mg/kg bw/day
Basis:
actual ingested - No. of animals per sex per dose:
- 20
- Control animals:
- yes, plain diet
- Details on study design:
- Groups of 20 male and 20 female Wistar SPF rats were fed 0 or 1% anethole in the diet (approximately 600-1,500 mg/kg bw/day) for 70 days prior to mating. Four paired groups were formed: (1) control males X control females; (2) control males X treated females; (3) treated males X control females; and (4) treated males X treated females. During the mating period of 15 days, the first 3 groups were maintained on basal diet; whereas, group 4 received treated diet. During gestation and lactation, females of groups 2, 3 and 4 were maintained on 1% anethole diet. Offspring from groups 1 and 4 were used for propagating the next generation and were raised on the same dietary treatment as their parents (70 days from time of weaning). At approximately 3 months of age, rats were bred to obtain the next generation. A similar procedure was followed to obtain the 3rd and 4th generations. The treatment groups for F1, F2 and F3 were: (1) control males X control females; and (2) treated males X treated females. Mortality, body weight, food consumption, and reproductive performance (fertility, sex ratio, date of birth, stillbirths, clinical observations, litter size, litter viability) were monitored.
- Statistics:
- Yes, one factor variance analysis, Fischer test, t-test, Chisquare test
- Clinical signs:
- no effects observed
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- mortality observed, non-treatment-related
- Body weight and weight changes:
- effects observed, non-treatment-related
- Food consumption and compound intake (if feeding study):
- effects observed, non-treatment-related
- Food efficiency:
- no effects observed
- 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
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- effects observed, non-treatment-related
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- no effects observed
- Key result
- Dose descriptor:
- NOAEC
- Effect level:
- > 600 - < 1 500 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- clinical signs
- Clinical signs:
- no effects observed
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- mortality observed, non-treatment-related
- Body weight and weight changes:
- effects observed, non-treatment-related
- 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
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- not specified
- Key result
- Dose descriptor:
- NOAEC
- Effect level:
- > 600 - < 1 500 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- clinical signs
- Clinical signs:
- no effects observed
- Dermal irritation (if dermal study):
- not specified
- Mortality / viability:
- not specified
- Body weight and weight changes:
- effects observed, non-treatment-related
- 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
- Sexual maturation:
- no effects observed
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings:
- not specified
- Other effects:
- not specified
- Developmental immunotoxicity:
- effects observed, non-treatment-related
- Key result
- Dose descriptor:
- NOAEC
- Generation:
- F1
- Effect level:
- >= 600 - <= 1 500 mg/kg bw/day
- Based on:
- act. ingr.
- Sex:
- male/female
- Basis for effect level:
- other: No effects on reproductive performance
- Key result
- Dose descriptor:
- NOAEC
- Generation:
- F1
- Effect level:
- >= 600 - <= 1 500 mg/kg bw/day
- Based on:
- act. ingr.
- Sex:
- male/female
- Basis for effect level:
- other: No effects on reproductive performance.
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality / viability:
- not specified
- Body weight and weight changes:
- not specified
- 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
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings:
- not specified
- Other effects:
- not specified
- Behaviour (functional findings):
- not specified
- Developmental immunotoxicity:
- not specified
- Key result
- Dose descriptor:
- NOAEC
- Generation:
- F2
- Effect level:
- >= 600 - <= 1 500 mg/kg bw/day
- Based on:
- act. ingr.
- Sex:
- male/female
- Basis for effect level:
- other: No effects on reproductive performance.
- Reproductive effects observed:
- not specified
- Conclusions:
- The reduced palatability of the diet was considered to be responsible for the lower body weight gain and body weights of the rats receiving anethole.
trans-Anethole did not affect the reproductive performance of rats over 4 generations.
Reference
P1: no deaths, reduced body weight gain and body weight in treated rats, reduced food consumption in treated rats for 1st 2 weeks, no effect on reproductive performance.
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 600 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Effects on developmental toxicity
Link to relevant study records
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- GLP compliance:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- Groups of 10 female rats were gavaged with anethole 0, 35, 175, or 350 mg/kg bw/day in corn oil for 7 days prior to co habitation with male rats until day 4 of lactation for those rats producing litters and day 25 of cohabitation for those rats without confirmed mating dates. Body weight and feed consumption was monitored. Fertility, gestation index, implantation sites, length of gestation, number of stillborn pups, litter size, pup viability, pup weight, and clinical observations of pups were recorded. On day 4 of lactation, pups were examined, killed, and discarded.
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Duration of treatment / exposure:
- Approximately 32 days
- Frequency of treatment:
- Daily
- Duration of test:
- Approximately 32 days
- No. of animals per sex per dose:
- 10
- Control animals:
- yes, concurrent vehicle
- Maternal examinations:
- yes
- Ovaries and uterine content:
- yes
- Fetal examinations:
- yes
- Statistics:
- Yes, Bartlett's Test, ANOVA, Dunnett's test, Kruskal-Wallis Test, Dunn's test, Fischer's Test
- Indices:
- no data
- Historical control data:
- no data
- Details on maternal toxic effects:
- Maternal toxic effects:yes
Details on maternal toxic effects:
At 350 mg/kg bw/day: significantly reduced mean body weight and feed consumption throughout study; 1 rat found dead on day 20 of gestation (necropsy showed congested lungs, but uterine contents showed 17 normal fetuses and 2 early resorptions); 2 rats had urine-stained abdominal fur during the premating period, one of these rats also "had a tan perivaginal substance and appeared pale on day 23 of gestation, and during lactation was emaciated and pale and had an ungroomed coat and red perioral and perivaginal substances"; in necropsy 1 rat had a raised yellow area in the liver, 1 rat had hematomas on the vessels supplying the implantation sites; average gestation duration was increased (number of dams delivering on days 23 and 24 was increased over controls); number of dams with stillborn pups and with all pups dying before postpartum day 4 was significantly increased (P less than or equal to 0.01).
At 175 mg/kg bw/day, mean body weight was significantly decreased on gestation days 6 and 14; feed consumption was significantly reduced during premating days 1-8 but not during gestation - Dose descriptor:
- NOAEL
- Effect level:
- ca. 35 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- LOAEL
- Effect level:
- ca. 175 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:yes
Details on embryotoxic / teratogenic effects:
At 350 mg/kg bw/day, number of live born pups (75) was significantly decreased (P less than or equal to 0.01) compared to controls (147), number of stillborn pups (18) was significantly increased (P less than or equal to 0.01) compared to controls (0), number of pups dying on day 1 and days 2-4 (8 and 7 respectively) was significantly increased (P less than or equal to 0.01) compared to controls (0 and 0, respectively), viability index (number of live pups on postpartum day 4/number of live born pups on postpartum day 1) was significantly (P less than or equal to 0.01) decreased (80%) compared to controls (99.3%); number of surviving pups/litter on postpartum day 4 (7.5) was significantly (P less than or equal to 0.01) decreased compared to controls (14.6); live litter size on postpartum day 4 (12.0) was significantly (P less than or equal to 0.05) decreased compared to controls (14.6); pup weight/litter on postpartum day 1 (5.1 g) was significantly (P less than or equal to 0.05) decreased compared to controls (6.2 g).
No other effects were reported at the other doses. No anomalies were reported. - Dose descriptor:
- NOAEL
- Effect level:
- ca. 175 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- reduction in number of live offspring
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 350 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- reduction in number of live offspring
- Abnormalities:
- not specified
- Developmental effects observed:
- not specified
- Conclusions:
- Anethole did not cause any developmental effects on the rat fetus at doses below those causing maternal toxicity (reduced body weight and feed consumption).
Reference
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 35 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Additional information
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