Registration Dossier
Registration Dossier
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EC number: 425-220-8 | CAS number: 5945-33-5
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 72 h
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study
Data source
Reference
- Reference Type:
- other: Provided by ECHA
- Title:
- Unnamed
- Year:
- 1 999
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- -
- EC Number:
- 425-220-8
- EC Name:
- -
- Cas Number:
- 5945-33-5
- Molecular formula:
- C39H34O8P2
- IUPAC Name:
- 4-(2-{4-[(diphenoxyphosphoryl)oxy]phenyl}propan-2-yl)phenyl diphenyl phosphate; 4-{2-[4-({[4-(2-{4-[(diphenoxyphosphoryl)oxy]phenyl}propan-2-yl)phenoxy](phenoxy)phosphoryl}oxy)phenyl]propan-2-yl}phenyl diphenyl phosphate
- Details on test material:
- No data, but ECHA think it's identical with our substance.
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- ICR
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- no data
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- Corn oil
- Details on exposure:
- No data
- Duration of treatment / exposure:
- Male: 0 mg/kg; No. of animals: 5; Sacrifice time: 24 hours
Male: 1250 mg/kg; No. of animals: 5; Sacrifice time: 24 hours
Male: 2500 mg/kg; No. of animals: 5; Sacrifice time: 24 hours
Male: 5000 mg/kg; No. of animals: 5; Sacrifice time: 24 hours
Male: 0 mg/kg; No. of animals: 5; Sacrifice time: 48 hours
Male: 1250 mg/kg; No. of animals: 5; Sacrifice time: 48 hours
Male: 2500 mg/kg; No. of animaIs: 5; Sacrifice time: 48 hours
Male: 5000 mg/kg; No. of animals: 5; Sacrifice time: 48 hours
Male: 0 mg/kg; No. of animals: 5; Sacrifice !ime: 72 hours
Male: 1250 mg/kg; No. of animals: 5; Sacrifice time: 72 hours
Male: 2500 mg/kg; No. of animals: 5; Sacrifice time: 72 hours
Male: 5000 mg/kg; No. of animals: 5; Sacrifice time: 72 hours
Female: 0 mg/kg; No. of animals: 5; Sacrifice times: 24 hours
Female: 1250 mg/kg; No. of animals: 5; Sacrifice times: 24 hours
Female: 2500 mg/kg; No. of animals: 5; Sacrifice times: 24 hours
Female: 5000 mg/kg; No. of animals: 5; Sacrifice times: 24 hours
Female: 0 mg/kg; No. of animals: 5; Sacrifice times: 48 hours
Female: 1250 mg/kg; No. of animals: 5; Sacrifice times: 48 hours
Female: 2500 mg/kg; No. of animals: 5; Sacrifice times: 48 hours
Female: 5000 mg/kg; No. of animals: 5; Sacrifice times: 48 hours
Female: 0 mg/kg; No. of animals: 5; Sacrifice times: 72 hours
Female: 1250 mg/kg; No. of animals: 5; Sacrifice times: 72 hours
Female: 2500 mg/kg; No. of animals: 5; Sacrifice times: 72 hours
Female: 5000 mg/kg; No. of animals: 5; Sacrifice times: 72 hours - Frequency of treatment:
- No data
- Post exposure period:
- No data
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
0 mg/kg
Basis:
no data
- Remarks:
- Doses / Concentrations:
1250 mg/kg
Basis:
no data
- Remarks:
- Doses / Concentrations:
2500 mg/kg
Basis:
no data
- Remarks:
- Doses / Concentrations:
5000 mg/kg
Basis:
no data
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- No data
Examinations
- Tissues and cell types examined:
- Doses producing toxicity:
From a preliminary test, a maximum dose level of 5000 mg/kg was selected.
No animals died during the study. Clinical signs included lethargy which was observed in all animals at all dose levels on the days following dosing.
Slight reductions (up to 13%) in the ration of polychromatic erthrocytes to total erythrocytes were observed, these were within hislorical conlrol ranges. - Details of tissue and slide preparation:
- No data
- Evaluation criteria:
- No data
- Statistics:
- No data
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Remarks:
- No significant increases in the frequency of micronuclealed immalure erythrocytes were observed in groups of mice treated with the test substance.
- Toxicity:
- no effects
- Vehicle controls validity:
- not specified
- Negative controls validity:
- not specified
- Positive controls validity:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
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