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Toxicological information

Repeated dose toxicity: oral

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Administrative data

Endpoint:
repeated dose toxicity: oral, other
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Data is from monograph

Data source

Reference
Reference Type:
secondary source
Title:
Fragrance Raw Material Monograph: α-METHYL NAPHTHYL KETONE
Author:
D. L. J. Opydyke
Year:
1980
Bibliographic source:
Food and cosmetic toxicology

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Refer below principle
Principles of method if other than guideline:
Reproductive toxicity study was conducted for test chemicals in rats
GLP compliance:
not specified
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
1'-acetonaphthone
EC Number:
213-384-1
EC Name:
1'-acetonaphthone
Cas Number:
941-98-0
Molecular formula:
C12H10O
IUPAC Name:
1'-acetonaphthone
Details on test material:
- Name of test material: α-methyl naphthyl ketone
- IUPAC name: 1-(1-naphthyl)ethanone
- Molecular formula: C12H10O
- Molecular weight: 170.21 g/mol
- Substance type: Organic
- Physical state: Liquid
- Impurities (identity and concentrations): No data available

Test animals

Species:
rat
Strain:
not specified
Details on species / strain selection:
No data
Sex:
not specified
Details on test animals or test system and environmental conditions:
No data

Administration / exposure

Route of administration:
oral: feed
Details on route of administration:
No data
Vehicle:
other: Feed
Details on oral exposure:
PREPARATION OF DOSING SOLUTIONS: α-methyl naphthyl ketone was mixed with feed to give a dose range of 3, 10, 60 or 100 mg/Kg

DIET PREPARATION
- Rate of preparation of diet (frequency): No data
- Mixing appropriate amounts with (Type of food): No data
- Storage temperature of food: No data

VEHICLE
- Justification for use and choice of vehicle (if other than water): Feed
- Concentration in vehicle: 3, 10, 60 or 100 mg/Kg
- Amount of vehicle (if gavage): No data
- Lot/batch no. (if required): No data
- Purity: No data
Analytical verification of doses or concentrations:
not specified
Details on analytical verification of doses or concentrations:
No data
Duration of treatment / exposure:
No data
Frequency of treatment:
No data
Doses / concentrations
Remarks:
3, 10, 60 or 100 mg/Kg
No. of animals per sex per dose:
No data
Control animals:
not specified
Details on study design:
No data
Positive control:
No data

Examinations

Observations and examinations performed and frequency:
CAGE SIDE OBSERVATIONS: Yes
- Time schedule: No data available
- Cage side observations checked in table [No.?] were included. Growth

DETAILED CLINICAL OBSERVATIONS: No data available
- Time schedule: No data available

BODY WEIGHT: No data available
- Time schedule for examinations: No data available

FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): No data available
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No data available
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No data available

FOOD EFFICIENCY: No data
- 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: No data available

WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data available
- Time schedule for examinations: No data available

OPHTHALMOSCOPIC EXAMINATION: No data available
- Time schedule for examinations: No data available
- Dose groups that were examined: No data available

HAEMATOLOGY: No data available
- Time schedule for collection of blood: No data available
- Anaesthetic used for blood collection: No data available
- Animals fasted: No data available
- How many animals: No data available
- Parameters checked in table [No.?] were examined. No data available

CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: No data available
- Animals fasted: Yes
- How many animals: No data available
- Parameters checked in table [No.?] were examined. Hepatic protein content, hepatic nitrogen content, ascorbic acid content of adrenal glands

URINALYSIS: No data
- Time schedule for collection of urine: No data available
- Metabolism cages used for collection of urine: No data available
- Animals fasted: No data available
- Parameters checked in table [No.?] were examined. No data available

NEUROBEHAVIOURAL EXAMINATION: No data available
- Time schedule for examinations: No data available
- Dose groups that were examined: No data available
- Battery of functions tested: sensory activity / grip strength / motor activity / other: No data available

OTHER: No data available
Sacrifice and pathology:
No data
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):
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:
no effects observed
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
Details on results:
No data

Effect levels

Dose descriptor:
NOAEL
Effect level:
100 mg/kg diet
Based on:
test mat.
Sex:
not specified
Basis for effect level:
other: No alterations noted at the mentioned dose level
Remarks on result:
other: No toxic effects 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 test chemical was considered to be 100 mg/Kg bw/ day in rts for
Executive summary:

Repeated dose toxicity study was conducted on rats for the test compound at the dosage levels of 3, 10, 60 or 100 mg/Kg bw/day.  The animals were observed for clinical signs and clinical chemistry changes. No influence on the rate of hepatic protein recovery after fasting, on the hepatic nitrogen content, on the ascorbic acid content of the adrenal glands or on blood chemistry was noted. With oral doses of 3 or 10mg given every other day, growth was not significantly towered in rats fed 11 or 19% protein diets. Based on the observations made, the No Observed Adverse Effect Level (NOAEL) for test chemical was considered to be 100 mg/Kg bw/ day.