Registration Dossier

Diss Factsheets

Toxicological information

Genetic toxicity: in vitro

Currently viewing:

Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
January 1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Performed before test guidelines and GLP principles were in place, but performed according to the published method of Ames: only two strains were used to proof earlier positive results.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report date:
1980

Materials and methods

Principles of method if other than guideline:
Procedures followed in the present study, mimic as closely as possible those described by Ames and coworkers in Mutation Research 31, 1975, 347-365. Only S. typhimurium TA1535 and TA100 have been tested, based on findings in another performed study.
GLP compliance:
no
Remarks:
before GLP came into force
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction mass of 2-ethyl-2-[[3-(2-methylaziridin-1-yl)propionyl]methyl]propane-1,3-diyl bis(2-methylaziridine-1-propionate) and 2,2-bis({[3-(2-methylaziridin-1-yl)propanoyl]oxy}methyl)butyl 3-[2,2-bis({[3-(2-methylaziridin-1-yl)propanoyl]oxy}methyl)butoxy]propanoate
EC Number:
939-180-9
Molecular formula:
Not relevant - Multiconstituent substance
IUPAC Name:
Reaction mass of 2-ethyl-2-[[3-(2-methylaziridin-1-yl)propionyl]methyl]propane-1,3-diyl bis(2-methylaziridine-1-propionate) and 2,2-bis({[3-(2-methylaziridin-1-yl)propanoyl]oxy}methyl)butyl 3-[2,2-bis({[3-(2-methylaziridin-1-yl)propanoyl]oxy}methyl)butoxy]propanoate
Details on test material:
- Name of test material (as cited in study report): CX-100
- Substance type: polyfunctional aziridene crosslinkers
- Physical state: yellow liquid
- Lot/batch No.: Three batches were used for testing, CX-100 PCH Lot 36.942, CX-100 PCH lot 36110 and CX-100 PCI.
- Other: Received material January 30, 1980

Method

Species / strain
Species / strain / cell type:
S. typhimurium, other: TA100 and TA1535
Details on mammalian cell type (if applicable):
approx. 10E9 bacteria/ml were used
Metabolic activation:
with and without
Metabolic activation system:
Aroclor 1254 induced livers of male wistar rats
Test concentrations with justification for top dose:
0, 0.06, 0.18, 0.56, 1.67, 5, 10 mg/plate (+/- S9 mix)
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: DMSO
Controlsopen allclose all
Negative solvent / vehicle controls:
yes
Remarks:
DMSO
Positive controls:
yes
Positive control substance:
sodium azide
Remarks:
1.3 µg/plate

Migrated to IUCLID6: without S9 mix
Negative solvent / vehicle controls:
yes
Remarks:
DMSO
Positive controls:
yes
Positive control substance:
other: 2-aminoanthracene (with S9 mix)
Remarks:
0.5 µg/plate
Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar (plate incorporation); test concentrations were prepared immediately before use.

DURATION
- Exposure duration: 3 days

NUMBER OF REPLICATIONS: triplicate, positive controls in duplicate

DETERMINATION OF CYTOTOXICITY
Less dense background lawn of bacterial growth.

Results and discussion

Test results
Species / strain:
S. typhimurium, other: TA100 and TA1535
Metabolic activation:
with and without
Genotoxicity:
positive
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
at 10 mg/plate the substance was toxic for the bacteria
Vehicle controls validity:
valid
Positive controls validity:
valid
Additional information on results:
The positive effect, was more pronounced in the presence than in the absence of the liver microsome activation system.

COMPARISON WITH HISTORICAL CONTROL DATA: historical positive control data are included in the report for 2-aminoanthracene (not for sodium azide)

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
positive with and without metabolic activation

CX-100 showed to be positive in two strains, TA100 and TA1535, in an Ames test with and without metabolic activation.