Registration Dossier
Registration Dossier
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EC number: 203-564-8 | CAS number: 108-24-7
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Adopted according to OECD SIDS
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
- Principles of method if other than guideline:
- This micronucleus test was performed as part of a 13-week repeated dose study according to OECD TG 413. Details of the test are not available. Bone marrow samples were analyzed to assess the mutagenic potential of the test substance in an in vivo cytogenic system. The methods and experimental design complied with EEC Annex to Directive 92/69/EEC (Method B12).
- GLP compliance:
- yes
- Remarks:
- Huntingdon Life Sciences
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- Acetic anhydride
- EC Number:
- 203-564-8
- EC Name:
- Acetic anhydride
- Cas Number:
- 108-24-7
- Molecular formula:
- C4H6O3
- IUPAC Name:
- acetyl acetate
- Details on test material:
- - Name of test material (as cited in study report): acetic anhydride
- Physical state: liquid
- Analytical purity: >99 %
- Storage condition of test material: ambient temperature, dry
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK) Limited
- Age at study initiation: 6-7 weeks
- Mean weight at study initiation: male 227 g, female 184 g
- Housing: 5 per cage
- Diet (e.g. ad libitum): SDS Rat and Mouse No 1 SQC modified maintenance diet
- Water (e.g. ad libitum): tap water
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3
- Humidity (%): 55±15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- inhalation
- Vehicle:
- - Vehicle(s)/solvent(s) used: none
- Details on exposure:
- TYPE OF INHALATION EXPOSURE: whole body
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: 2.43 m3, stainless steel and glass
- Source and rate of air: Air was passed through the vapouriser at a rate of 80 l/min
- System of generating vapor: The vapor was generated by metering the test substance from a polypropylene syringe mounted on an infusion pump to a glass frit contained in a glass vessel. In order to facilitate production of the vapor, the air to the vaporizer passed through a copper coil immersed in a water bath, maintained at 60 ± 1°C. The vapor/air mixture passed out of the vaporizer into the chamber inlet ducting. The vapor generating equipment was housed in an extracted cabinet. Different chamber concentrations were achieved by varying the syringe pump infusion rate. For all groups the vapor/air mixture produced passed along the chamber inlet ducting to a tangential inlet mounted at the apex of the chamber where it was mixed with additional diluent air at a rate (approximately 570 L/min) sufficient to maintain the total chamber airflow at approximately 650 L/min.
- Temperature, humidity in air chamber: 20.4-20.8 °C, 56.1-66.7 % - Duration of treatment / exposure:
- 13 weeks
- Frequency of treatment:
- 6 h/day, 5 days/week
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
1, 5, 20 ppm
Basis:
nominal conc.
- Remarks:
- Doses / Concentrations:
0.98, 4.96, 20.0 ppm
Basis:
analytical conc.
- Remarks:
- Doses / Concentrations:
0.0042, 0.021, 0.085 mg/l
Basis:
other: calculated with conversion factor, 1 ppm = 0.00424 mg/l
- No. of animals per sex per dose:
- 10
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- yes, no further data
Examinations
- Tissues and cell types examined:
- bone marrow
- Details of tissue and slide preparation:
- no data
- Evaluation criteria:
- no data
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Remarks:
- only irritating effects of the respiratory tract
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Acetic anhydride did not cause any substantial increase in the incidence of micronucleated immature erythrocytes or any substantial decrease in the proportion of immature erythrocytes.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
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