2'-acetonaphthone

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:

data from handbook or collection of data

Justification for type of information:

Data is from peer reviewed publication

Data source

Reference

Reference Type:

publication

Title:

Repeated dose oral toxicity study of the test chemical

Author:

Oser et al

Year:

1965

Bibliographic source:

Fd Chem. Toxicology,1965

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Refer below principle

Principles of method if other than guideline:

A 90-day repeated dose toxicity study was performed to investigate the toxic nature of 1-(2-naphthyl)ethanone following dietary administration to male and female rats.

GLP compliance:

no

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

2'-acetonaphthone

EC Number:

202-216-2

EC Name:

2'-acetonaphthone

Cas Number:

93-08-3

Molecular formula:

C12H10O

IUPAC Name:

1-(naphthalen-2-yl)ethan-1-one

Details on test material:

- Name of test material: Methyl beta- naphthyl ketone
- Molecular formula: C12H10O
- Molecular weight: 170.21 g/mol
- Substance type: Organic
- Physical state: Solid

Test animals

Species:

rat

Strain:

other: FDRL

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: No data
- Age at study initiation: No data
- Weight at study initiation: No data
- Fasting period before study: No data
- Housing: Housed individually in wiremesh cages
- Diet (e.g. ad libitum): Purina Laboratory Chow ad libitum
- Water (e.g. ad libitum): Fresh water ad libitum
- Acclimation period: No data

Administration / exposure

Route of administration:

oral: feed

Vehicle:

cotton seed oil

Details on oral exposure:

PREPARATION OF DOSING SOLUTIONS: The test chemical was diluted with cotton seed oil in a concentration sufficient to provide the predetermined dosage in 2% of the diet. The daily consumption of the test chemical was 33 mg/kg body weight/day for males and 36.9 mg/kg body weight/day for females.

DIET PREPARATION
- Rate of preparation of diet (frequency): biweekly
- Mixing appropriate amounts with (Type of food): commercial diet (Purina Laboratory Chow)
- Storage temperature of food: No data
VEHICLE
- Justification for use and choice of vehicle (if other than water): Cotton seed oil
- Concentration in vehicle: 0, 33 mg/kg/day (males) and 36.9 mg/kg/day (females)
- 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

Duration of treatment / exposure:

90 days

Frequency of treatment:

daily

Doses / concentrations

Doses / concentrations 1

Dose / conc.:

0 mg/kg bw/day (nominal)

Remarks:

control

Doses / concentrations 2

Dose / conc.:

33 mg/kg bw/day (nominal)

Remarks:

male

Doses / concentrations 3

Dose / conc.:

36.9 mg/kg bw/day (nominal)

Remarks:

female

No. of animals per sex per dose:

15 male and 15 female rats

Control animals:

yes, plain diet

Details on study design:

No data

Positive control:

No data

Examinations

Observations and examinations performed and frequency:

DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: No data
BODY WEIGHT: Yes
- Time schedule for examinations: No data
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: Yes
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No
FOOD EFFICIENCY:
- 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: Efficiency of food utilization (EFU), body weight gain (g)/ 100 g food eaten.
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data
- Time schedule for examinations:
OPHTHALMOSCOPIC EXAMINATION: No data
- Time schedule for examinations:
- Dose groups that were examined:
HAEMATOLOGY: Yes
- Time schedule for collection of blood: on 8 rats of each sex at a 6-week period, and in all rats at 12 weeks
- Anaesthetic used for blood collection: Yes (identity) / No / No data
- Animals fasted: No data
- How many animals: 15 males and 15 females
- Parameters checked in table [No.?] were examined. No data

CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: on 8 rats of each sex at a 6-week period, and in all rats at 12 weeks
- Animals fasted: No data
- How many animals: 15 males and 15 females
- Parameters checked in table [No.?] were examined. No data
URINALYSIS: No data
- Time schedule for collection of urine: No data
- Metabolism cages used for collection of urine: No data
- Animals fasted: No data
- Parameters checked in table [No.?] were examined. No data
NEUROBEHAVIOURAL EXAMINATION: No data
- Time schedule for examinations: No data
- Dose groups that were examined: No data
- Battery of functions tested: sensory activity / grip strength / motor activity / other: No data

OTHER:

Sacrifice and pathology:

The test was terminated at 90 days and at autopsy, liver and kidney weights were recorded and the following organs from half the animals in each group were taken for histological examination: liver, kidneys, stomach, small and large intestines, spleen, pancreas, heart, lungs, bone marrow, muscle, brain, spinal cord, bladder, adrenals, thyroid, pituitary, gonads, salivary glands, and lymph nodes.

Other examinations:

No data

Statistics:

No data

Results and discussion

Results of examinations

Clinical signs:

not specified

Mortality:

not specified

Body weight and weight changes:

not specified

Food consumption and compound intake (if feeding study):

not specified

Food efficiency:

no effects observed

Water consumption and compound intake (if drinking water study):

not examined

Ophthalmological findings:

not examined

Haematological findings:

no effects observed

Clinical biochemistry findings:

no effects observed

Urinalysis findings:

not examined

Behaviour (functional findings):

not examined

Immunological findings:

not specified

Organ weight findings including organ / body weight ratios:

no effects observed

Gross pathological findings:

no effects observed

Neuropathological findings:

not specified

Histopathological findings: non-neoplastic:

no effects observed

Histopathological findings: neoplastic:

not specified

Other effects:

not specified

Details on results:

-Measurements of growth, haematological and blood clinical chemical analysis, gross and histological examination at necropsy revealed no adverse effects related to the test chemical administration.

-No significant test chemical-related gross pathological and histopathological changes were observed at autopsy in any rats.

Effect levels

1

Key result

Dose descriptor:

NOAEL

Effect level:

33 mg/kg bw/day (nominal)

Based on:

test mat.

Sex:

male

Basis for effect level:

body weight and weight gain

clinical biochemistry

food consumption and compound intake

food efficiency

gross pathology

haematology

histopathology: non-neoplastic

organ weights and organ / body weight ratios

2

Key result

Dose descriptor:

NOAEL

Effect level:

36.9 mg/kg bw/day (nominal)

Based on:

test mat.

Sex:

female

Basis for effect level:

body weight and weight gain

clinical biochemistry

food consumption and compound intake

food efficiency

gross pathology

haematology

histopathology: non-neoplastic

organ weights and organ / body weight ratios

Target system / organ toxicity

Critical effects observed:

no

Applicant's summary and conclusion

Conclusions:

The NOAEL of 1-(2-naphthyl)ethanone for repeated dose exposure was considered to be 33 mg/kg body weigh/day for males and 36.9 mg/kg body weigh/day for females.

Executive summary:

A 90-day repeated dose toxicity study was performed to investigate the toxic nature of 1-(2-naphthyl)ethanone in 15 male and 15 female rats of the FDRL strain.The test chemical was diluted in cotton seed oil in a concentration sufficient to provide the predetermined dosage in 2% of the diet. The daily consumption of the test chemical was 33 mg/kg body weight/day for males and 36.9 mg/kg body weight/day for females. The individual body weight and food consumption was recorded during the administrating period. In addition, haematological and blood chemical determinations were made on 8 rats of each sex at a 6-week period, and in all rats at 12 weeks. The tests were terminated at 90 days and at autopsy, liver and kidney weights were recorded. The following organs from half the animals in each group were taken for histological examination: liver, kidneys, stomach, small and large intestines, spleen, pancreas, heart, lungs, bone marrow, muscle, brain, spinal cord, bladder, adrenals, thyroid, pituitary, gonads, salivary glands, and lymph nodes.Measurements of growth, haematological andbloodclinical chemicalanalysis,gross and histological examinationof the major organsrevealed no significant adverse effectsrelated to the test chemical administration.Hence,the repeated exposure to 1-(2-naphthyl)ethenone up to concentration of 33 and 36.9 mg/kg body weight/day exerted no specific target organ toxicity when administered in feed to rats for 90 days.The NOAEL (NoObservedAdverseEffectLevel ) of the test chemical was considered to be 33 mg/kgbody weigh/dayper day for males and 36.9 mg/kgbody weight/dayfor females.