Registration Dossier
Registration Dossier
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EC number: 231-323-7 | CAS number: 7492-66-2
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- Data is from secondary literature
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Safety Evaluation of Certain Food Additives and Contaminants
- Author:
- Joint FAO/WHO Expert Committee on Food Additives (JECFA) World Health Organization
- Year:
- 2 002
- Bibliographic source:
- WHO Food Additive Series: 48, 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Refer below principle
- Principles of method if other than guideline:
- Repeated dose oral toxicity test was performed on male and female rats to determine the oral toxic nature of Citral diethylacetal
- GLP compliance:
- no
Test material
- Reference substance name:
- 1,1-diethoxy-3,7-dimethylocta-2,6-diene
- EC Number:
- 231-323-7
- EC Name:
- 1,1-diethoxy-3,7-dimethylocta-2,6-diene
- Cas Number:
- 7492-66-2
- Molecular formula:
- C14H26O2
- IUPAC Name:
- 1,1-diethoxy-3,7-dimethylocta-2,6-diene
- Details on test material:
- - Name of test material: 1,1-diethoxy-3,7-dimethylocta-2,6-diene
- Molecular formula: C14H26O2
- Molecular weight: 226.35 g/mole
- Smiles notation: O(C(OCC)C=C(CCC=C(C)C)C)CC
- Substance type: Liquid
- Physical state: Organic
- Impurities (identity and concentrations): No data
Constituent 1
- Specific details on test material used for the study:
- - Name of test material: Citral diethylacetal
- IUPAC name: 1,1-diethoxy-3,7-dimethylocta-2,6-diene
- Molecular formula: C14H26O2
- Molecular weight: 226.357 g/mol
- Substance type: Organic
- Physical state: Solid
- Purity: No data
- Impurities (identity and concentrations): No data
Test animals
- Species:
- rat
- Strain:
- not specified
- Details on species / strain selection:
- No data
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- No data available
Administration / exposure
- Route of administration:
- oral: unspecified
- Details on route of administration:
- No data
- Vehicle:
- not specified
- Details on oral exposure:
- No data available
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- No data available
- Duration of treatment / exposure:
- 84 days (12 weeks)
- Frequency of treatment:
- Daily
Doses / concentrations
- Remarks:
- 0 or 56 mg/Kg bw
- No. of animals per sex per dose:
- Total: 42
0 mg/Kg bw: 21 rats
56 mg/Kg bw: 21 rats - Control animals:
- yes, concurrent vehicle
- Details on study design:
- No data available
- Positive control:
- No data available
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: During the study
- Cage side observations checked in table [No.?] were included. The animals were observed for behaviour, appearance and growth
DETAILED CLINICAL OBSERVATIONS: Not specified
- Time schedule: Not specified
BODY WEIGHT: Not specified
- Time schedule for examinations: Not specified
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Yes
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Not specified
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: Not specified
FOOD EFFICIENCY: Yes
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: Not specified
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): Not specified
- Time schedule for examinations: Not specified
OPHTHALMOSCOPIC EXAMINATION: Not specified
- Time schedule for examinations: Not specified
- Dose groups that were examined: Not specified
HAEMATOLOGY: Yes
- Time schedule for collection of blood: Not specified
- Anaesthetic used for blood collection: Not specified
- Animals fasted: Not specified
- How many animals: Not specified
- Parameters checked in table [No.?] were examined. Haemoglobin concentration was determined
CLINICAL CHEMISTRY: Not specified
- Time schedule for collection of blood: Not specified
- Animals fasted: Not specified
- How many animals: Not specified
- Parameters checked in table [No.?] were examined. Not specified
URINALYSIS: Not specified
- Time schedule for collection of urine: Not specified
- Metabolism cages used for collection of urine: Not specified
- Animals fasted: Not specified
- Parameters checked in table [No.?] were examined. Not specified
NEUROBEHAVIOURAL EXAMINATION: Not specified
- Time schedule for examinations: Not specified
- Dose groups that were examined: Not specified
- Battery of functions tested: sensory activity / grip strength / motor activity / other: Not specified
IMMUNOLOGY: Not specified
- Time schedule for examinations: Not specified
- How many animals: Not specified
- Dose groups that were examined: Not specified
- Parameters checked in table [No.?] were examined. Not specified
OTHER: Not specified - Sacrifice and pathology:
- No dataGROSS PATHOLOGY: Yes, gross examination was performed to determine the organ weight
HISTOPATHOLOGY: Not specified - Other examinations:
- No data
- Statistics:
- No data
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- not specified
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- no effects observed
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- no effects observed
- 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:
- no effects observed
- Gross pathological findings:
- not specified
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
- Details on results:
- Clinical signs and mortality:
Clinical signs: The treated animals had normal behaviour and appearance during the study
Mortality: No data
Body weight and weight gain: No data
Food consumption and compound intake: The animals were note affected for food consumption
Food efficiency : The animals were note affected for food efficiency
Water consumption and compound intake: No data
Opthalmoscopic examination: No data
Haematology: No changes in haemoglobin concentration were observed
Clinical chemistry: No data
Urinanalysis: No data
Neurobehaviour: No data
Organ weights: Gross examination revealed no changes in organ weights
Gross pathology: No data
Histopathology: No data
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 56 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No significant changes were observed
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The No Observed Adverse Effect Level (NOAEL) for Citral diethylacetal is 56 mg/kg in male and female rats.
- Executive summary:
Repeated dose oral toxicity test was performed on male and female rats to determine the oral toxic nature of Citral diethyacetal. The animals were treated with the test chemical Citral diethylacetal at a dose level of 0 or 56 mg/Kg bw for 12 weeks (84 days). The animals were observed for Daily food consumption, growth rate, food intake and efficiency, gross pathology including organ weight and haemoglobin concentration. The treated animals had normal behaviour and appearance during the study. Growth, food intake, and efficiency of food use were reported not to be affected, and gross examination revealed no changes in organ weights or haemoglobin concentration. Hence, the No Observed Adverse Effect Level (NOAEL) for Citral diethylacetal is 56 mg/kg in male and female rats.
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