Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Repeated dose toxicity: oral

Currently viewing:

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

Constituent 1
Chemical structure
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 / concentrationsopen allclose all
Dose / conc.:
0 mg/kg bw/day (nominal)
Remarks:
control
Dose / conc.:
33 mg/kg bw/day (nominal)
Remarks:
male
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

open allclose all
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
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.