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Diss Factsheets

Toxicological information

Genetic toxicity: in vivo

Currently viewing:

Administrative data

Endpoint:
in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
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:
Gene mutation in vivo toxicity study if the test chemical
Author:
Wild et al
Year:
1983
Bibliographic source:
Food and chemical toxicology

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Refer below principle
Principles of method if other than guideline:
Micronucleus assay was performed in NMRI mice to determine the mutagenic nature of the test chemical
GLP compliance:
not specified
Type of assay:
other: Micronucleus assay in mice

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: 2'-acetonaphthone
- Molecular formula: C12H10O
- Molecular weight: 170.21 g/mol
- Substance type: Organic
- Physical state: Solid

Test animals

Species:
mouse
Strain:
NMRI
Details on species / strain selection:
No data available
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: lvanovas GmbH, Kisslegg
- Age at study initiation: 10 to 14 week old
- Weight at study initiation: No data
- Assigned to test groups randomly: No data
- Fasting period before study: No data
- Housing: No data
- Diet (e.g. ad libitum): standard chow (Altromin) ad libitum
- Water (e.g. ad libitum): Water ad libitum
- Acclimation period: No data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data
- Humidity (%):No data
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): No data

IN-LIFE DATES: From: To: No data

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
- Vehicle(s)/solvent(s) used: Olive oil
- Justification for choice of solvent/vehicle: The chemical was soluble in olive oil
- Concentration of test material in vehicle: 0, 340, 681 or 876 mg/Kg
- Amount of vehicle (if gavage or dermal): No data
- Type and concentration of dispersant aid (if powder): No data
- Lot/batch no. (if required): No data
- Purity: No data
Details on exposure:
No data
Duration of treatment / exposure:
0 and 24 hours
Frequency of treatment:
Once
Post exposure period:
6 hours
Doses / concentrations
Remarks:
0, 340, 681 or 876 mg/Kg
No. of animals per sex per dose:
Total: 16
0 mg/Kg: 4
405 mg/Kg: 4
876 mg/Kg: 4
Control animals:
yes, concurrent vehicle
Positive control(s):
No data available

Examinations

Tissues and cell types examined:
MIcronucleated Immature eythrocytes from bone marrow were examined.
Details of tissue and slide preparation:
CRITERIA FOR DOSE SELECTION: No data

TREATMENT AND SAMPLING TIMES ( in addition to information in specific fields): 30 hrs

DETAILS OF SLIDE PREPARATION: The smears were stained according to the method of Schmid (1976)

METHOD OF ANALYSIS: increase in the number of micronucleus

OTHER: No data
Evaluation criteria:
The smears were noted for micronucleated polychromatic erythrocytes.
Statistics:
Statistical significance was determined according to the methods of Kastenbaum & Bowman (1970).

Results and discussion

Test results
Sex:
male/female
Genotoxicity:
negative
Toxicity:
not specified
Vehicle controls validity:
not specified
Negative controls validity:
not specified
Positive controls validity:
not specified
Remarks on result:
other: No mutagenic potential
Additional information on results:
RESULTS OF RANGE-FINDING STUDY
- Dose range: No data
- Solubility: No data
- Clinical signs of toxicity in test animals: No data
- Evidence of cytotoxicity in tissue analyzed: No data
- Rationale for exposure: No data
- Harvest times: No data
- High dose with and without activation: No data
- Other: No data


RESULTS OF DEFINITIVE STUDY
- Types of structural aberrations for significant dose levels (for Cytogenetic or SCE assay): No data
- Induction of micronuclei (for Micronucleus assay):Yes
- Ratio of PCE/NCE (for Micronucleus assay): Refer table below
- Appropriateness of dose levels and route: Intra-peritoneal
- Statistical evaluation:No data

Applicant's summary and conclusion

Conclusions:
The test chemical of 1-(2-naphthyl)ethenone did not increase the frequency of micronucleated immature erythrocytes in treated NMR1 mice and hence, it is regarded non-mutagenic (negative) in mammalian erythrocyte micronucleus test.
Executive summary:

An in vivo micronucleus test was performed to investigate the mutagenic potential of 1-(2-naphthyl)ethenoneusing 10-14-week-old NMRI mice. The test chemical was dissolved in olive oil administered at the doses of 0, 340, 681 and 879 mg/kg by intraperitoneal injection. The mice were sacrificed, and bone-marrow smears were prepared 30 hours after treatment. The smears were stained and the mean numbers of micronucleated polychromatic erythrocytes (PE) per 1000 polychromatic erythrocytes were calculated.As seen by the results,the single intraperitoneal administration of 2'-acetonaphthone did not increase the frequency of micronucleated immature erythrocytes in the treated animals. Hence, the administration of 2-acetonaphthone to NMRI mice did not induced cytogenetic damages such as structural and numerical chromosome aberrations in the bone marrow cells and, consequently 2-acetonaphthone was regarded Non-mutagenic(negative) in mammalian erythrocyte micronucleus test.