Registration Dossier
Registration Dossier
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EC number: 204-557-2 | CAS number: 122-60-1
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / bone marrow chromosome aberration
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Scientific publication with restrictions compared to Guideline Study (limited documentation)
Data source
Reference
- Reference Type:
- publication
- Title:
- The inhalation toxicity of phenylglycidyl ether: Reproduction, mutagenic, teratogenic, and cytogenetic studies
- Author:
- James B. Terrill1, K.P. Lee, Rudolf Culik, Gerald L. Kennedy Jr.
- Bibliographic source:
- Toxicology and Applied Pharmacology, Volume 64, Issue 2, 30 June 1982, Pages 204-212
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 475 (Mammalian Bone Marrow Chromosome Aberration Test)
- Deviations:
- yes
- Remarks:
- limited documentation
- GLP compliance:
- no
Test material
- Reference substance name:
- Automatically generated during migration to IUCLID 6, no data available
- IUPAC Name:
- Automatically generated during migration to IUCLID 6, no data available
- Details on test material:
- Name: phenylglycidyl ether (PGE)
Purity 99.6 %
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- Source: Charles River
Administration / exposure
- Route of administration:
- inhalation: vapour
- Details on exposure:
- vapour generated from liquid heated to a polymer process temperature of 310°C
- Duration of treatment / exposure:
- 6 hours per day for 19 consecutive days
- Frequency of treatment:
- daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 1, 5, 12 ppm
Basis:
analytical conc.
- No. of animals per sex per dose:
- 6
- Control animals:
- yes, sham-exposed
- Positive control(s):
- no
Examinations
- Tissues and cell types examined:
- bone marrow smears
- Details of tissue and slide preparation:
- The bone marrow was removed from the femur, followed by suspension in Hank’s solution, and further in a hypotonic salt solution. Fixationof cells was performed in methanol-acetic acid.
Air-dried slides were stained by the Giemsa method, and chromosome spreads were examined for modal number and aberrations such as gaps, breaks, rearrangements, and multiple aberrations. At least 50 cells were examined from each animal.
Results and discussion
Test results
- Sex:
- male
- Genotoxicity:
- negative
- Remarks:
- high control level of 7.9 % with abberations
- Toxicity:
- not examined
- Vehicle controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
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