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Administrative data

Description of key information

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.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Link to relevant study records
Reference
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
Qualifier:
according to
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
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
Species:
rat
Strain:
not specified
Details on species / strain selection:
No data
Sex:
male/female
Details on test animals and environmental conditions:
No data available
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
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
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
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
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
Critical effects observed:
not specified
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
56 mg/kg bw/day
Study duration:
subchronic
Species:
rat
Quality of whole database:
Data is from secondary literature

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Repeated dose oral toxicity:

Various data available for the target chemical was reviewed to determine the oral toxic nature of Citral diethyl acetal. The studies are as mentioned below:

Repeated dose oral toxicity test was performed (JECFA, 2002) on male and female rats to determine the oral toxic nature of Citral diethyacetal (CAS no 7492 -66 -2). 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.

Repeated dose oral toxicity study was performed to determine the oral toxic nature of Citral diethyl acetal. The chemical was administered orally via gavage at 0, 125, 250 or 500 mg/kg-day dissolved in corn oil or methyl cellulose to female Sprague-Dawley rats 7 days prior to cohabitation and through cohabitation, gestation, delivery and day 4 of lactation. The animals were necopsied and examined for gross lesions. Female rats showed clinical signs and lower body weights and body weight gains than controls at 250 and 500 mg/kg-day. Based on the observations made, the No Observed Adverse Effect Level (NOAEL) for Citral diethyl acetal is 125 mg/Kg/day when exposed to female Sprague Dawley rats.

Based on the data available for the target chemical, Citral diethylacetal does not exhibit oral toxic nature upon repeated exposure by oral route. Hence the test chemical is not likely to classify as toxicant upon repeated exposure by oral route.

Justification for classification or non-classification