1,1-diethoxy-3,7-dimethylocta-2,6-diene

Endpoint summary

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

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 or test system 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.