Copper, [29H,31H-phthalocyaninato(2-)-.kappa.N29,.kappa.N30,.kappa.N31,.kappa.N32]-, sulfonated, sodium salts

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:

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other: GLP compliant, near-guideline study, available as unpublished report, no restrictions, fully adequate for assessment.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:

1989

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

Test material information

Constituent 1

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

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.