Registration Dossier
Registration Dossier
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EC number: 947-968-9 | CAS number: -
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Food Flavouring amd Compounds of Related Structure II. Subacute and Chronic toxicity
- Author:
- E.C. Hagan. W.H. Hansen, O.G. Fitzhugh, P.M. Jenner, W.I. Jones, Jean M. Taylor, Eleanor L. Long, A.A. Nelson and J.B. Brouwer
- Year:
- 1 967
- Bibliographic source:
- Fd Cosmet. Toxicol. Vol. 5, pp. 141-157. Pergamon Press 1967
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 452 (Chronic Toxicity Studies)
- GLP compliance:
- no
- Limit test:
- 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:
- Osborne-Mendel
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Duration of treatment / exposure:
- 16 weeks
- Frequency of treatment:
- animals had unlimited access to food
Doses / concentrations
- Remarks:
- Doses / Concentrations:
10000 ppm
Basis:
actual ingested
- No. of animals per sex per dose:
- 10
- Control animals:
- yes
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
DETAILED CLINICAL OBSERVATIONS: Yes
BODY WEIGHT: Yes
- Time schedule for examinations: weekly
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): yes. food at all times
FOOD EFFICIENCY: no data
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): Yes, water at all times
OPHTHALMOSCOPIC EXAMINATION: No data
HAEMATOLOGY: Yes, white cell counts, red cell counts, haemoglobins and haemotocrits were measured at the end of the experiment
CLINICAL CHEMISTRY: No data
URINALYSIS: No data
NEUROBEHAVIOURAL EXAMINATION: No data
ORGAN WEIGHTS: yes: lives, kidneys, spleen heart, and testes
GROSS PATHOLOGY: no data
HISTOPATHOLOGY: non-neoplastic: Liver
HISTOPATHOLOGY: neoplastic: no effects
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- Liver: microscopic- slight hydropic changes of hepatic cells in males only
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- Liver: microscopic- slight hydropic changes of hepatic cells in males only
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Ophthalmological findings:
- not specified
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- Liver: microscopic- slight hydropic changes of hepatic cells in males only
- Histopathological findings: neoplastic:
- no effects observed
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 10 000 ppm
- Based on:
- act. ingr.
- Sex:
- male/female
- Basis for effect level:
- other: Liver: microscopic- slight hydropic changes of hepatic cells in males only
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The substance is not considered as toxic by repeated doses as only slight hydropic changes of hepatic cells in males only are produced by its action.
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