Registration Dossier
Registration Dossier
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EC number: 224-052-0 | CAS number: 4180-23-8
Toxicological information
Toxicity to reproduction
Administrative data
- 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
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 971
- Report date:
- 1971
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 416 (Two-Generation Reproduction Toxicity Study)
- GLP compliance:
- no
Test material
- Reference substance name:
- (E)-anethole
- EC Number:
- 224-052-0
- EC Name:
- (E)-anethole
- Cas Number:
- 4180-23-8
- Molecular formula:
- C10H12O
- IUPAC Name:
- 1-methoxy-4-prop-1-en-1-ylbenzene
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: feed
- Duration of treatment / exposure:
- F0:70 days
F1-F4: raised on treated diet
Doses / concentrations
- 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.
Examinations
- Statistics:
- Yes, one factor variance analysis, Fischer test, t-test, Chisquare test
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- 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 / performance (P0)
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- no effects observed
Details on results (P0)
P0: death of 1 control male and 1 treated female, no other deaths, decreased body weight in treated rats, decreased food consumption in treated rats, no effect on reproductive performance.
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.
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 levels (P0)
- 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
Results: P1 (second parental generation)
General toxicity (P1)
- 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 / performance (P1)
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- not specified
Effect levels (P1)
- 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
Results: F1 generation
General toxicity (F1)
- 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 (F1)
- Developmental immunotoxicity:
- effects observed, non-treatment-related
Details on results (F1)
F2 and F3: no deaths, reduced body weight gain and body weight in treated rats, reduced food consumption in treated rats for first 2 weeks, no effect on reproductive performance
Effect levels (F1)
open allclose all
- 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.
Results: F2 generation
General toxicity (F2)
- 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
Developmental neurotoxicity (F2)
- Behaviour (functional findings):
- not specified
Developmental immunotoxicity (F2)
- Developmental immunotoxicity:
- not specified
Effect levels (F2)
- 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.
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Applicant's summary and conclusion
- 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.
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