Registration Dossier

Administrative data

Endpoint:
in vivo mammalian germ cell study: cytogenicity / chromosome aberration
Remarks:
Type of genotoxicity: chromosome aberration
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1986
Rationale for reliability incl. deficiencies:
other: Scientifically defensible or guideline method was used, study conducted according to GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

Principles of method if other than guideline:
AGS mixtures were administered in a single oral dose to SD rats. Animals were sacreficed 6, 18 or 30 h after treatment. A positive control group was included (Cyclophosphamide). 2 H before scheduled sacrefice animals were administered colchicine at to arrest cells in metaphase. Animals were sacreficed and both femurs were removed from each animal and metaphase slides were prepared. Slides were stained, coded and scored for chromosomal aberrations (50 metaphase bone marrow cells/animal were evaluated.
GLP compliance:
yes
Type of assay:
chromosome aberration assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Carboxylic acids, di-, C4-6
EC Number:
271-678-5
EC Name:
Carboxylic acids, di-, C4-6
Cas Number:
68603-87-2
Molecular formula:
C5H8O4, C4H6O4, C6H10O4
IUPAC Name:
68603-87-2
Details on test material:
Adipic acid: 6-9%
Glutaic acid 30-35%
Succinic acid 8-11%
Nitric acid 0.5 - 3%
Lot: FIT-85-45,46,47; white solid powder

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Duration of treatment / exposure:
6, 18, 30 h
Frequency of treatment:
single treatment
Doses / concentrations
Remarks:
Doses / Concentrations:
1375, 2750, 5500 mg/kg bw
Basis:
nominal conc.
No. of animals per sex per dose:
5 males and 5 females
Control animals:
yes, concurrent vehicle

Examinations

Tissues and cell types examined:
Animals were sacreficed and both femurs were removed from each animal and metaphase slides were prepared.

Results and discussion

Test results
Sex:
male/female
Genotoxicity:
negative
Toxicity:
yes
Remarks:
death in high dose group
Vehicle controls validity:
valid
Positive controls validity:
valid

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative