Registration Dossier
Registration Dossier
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EC number: 939-524-8 | CAS number: 71949-28-5
Toxicological information
Genetic toxicity: in vivo
Currently viewing:
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:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant, near-guideline study, available as unpublished report, no restrictions, fully adequate for assessment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 475 (Mammalian Bone Marrow Chromosome Aberration Test)
- GLP compliance:
- yes
- Type of assay:
- chromosome aberration assay
Test material
- Reference substance name:
- Reaction product of [29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]zinc, sulphuric acid and caustic soda
- EC Number:
- 939-524-8
- Cas Number:
- 71949-28-5
- Molecular formula:
- C32 H12 N8 O12 S4 Zn. 4Na
- IUPAC Name:
- Reaction product of [29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]zinc, sulphuric acid and caustic soda
- Details on test material:
- Test article I.D.: K0698.01
Lot number: not provided
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: Harlan Sprague Dawley Inc., Frederick, MD
- Age at study initiation: 9-10 weeks
- Weight at study initiation: 267-339 g (males), 206-259 g (females)
- Assigned to test groups randomly: yes
- Fasting period before study: no
- Diet: Rodent chow, ad libitum
- Water: from a municipal water supply, ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- distilled water
- Details on exposure:
- Male and female Sprague-Dawley rats were treated with the substance at dose volumes of 1.6, 5.3 or 16 mL/kg body weight which was given as a single gavage administration. A cell cycle kinetics study indicated that the substance had no adverse effects on bone marrow cell cycle kinetics following acute administration of the high dose level.
- Duration of treatment / exposure:
- single administration
- Frequency of treatment:
- once
- Post exposure period:
- 6 or 12 hours
Doses / concentrations
- Remarks:
- Doses / Concentrations:
1.6, 5.3, 16 mL/kg bw
Basis:
actual ingested
- No. of animals per sex per dose:
- 5
- Control animals:
- other: yes, distilled water
- Positive control(s):
- cyclophosphamide (CP)
2'-5'-bromodeoxyuridine (BrdU)
Examinations
- Tissues and cell types examined:
- Bone marrow cells
- Details of tissue and slide preparation:
- Bone marrow cells arrested in the metaphase and collected 6 or 12 hours after administration were examined microscopically for numerical and structural chromosome aberrations.
- Evaluation criteria:
- The test article is considered to induce a positive response when the number of aberrations per cell at any dose or doses is significantly increased relative to the vehicle centrol. A significant trend test (p≤0.05, Cochran-Armitage Test) only, with no single dose significantly increased, is considered equivocal.
- Statistics:
- Male and female animals ware analyzed separately. The Fisher's Exact Test was used to compare the percentage of aberrant ceIls between each animal and it's corresponding vehicle control group. The Wilcoxon's Rank Sum Test was used to compare the average number of aberrations per cell per animal in each treatment group to the appropriate vehicle control group. The Cochran-Armitage Trend Test was employed to test for evidence of a dose response between groups at each sacrifice time point.
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- The substance did not induce numerical and structural chromosome aberrations.
Applicant's summary and conclusion
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