2-Propenoic acid, 2-cyano-, 1-methylheptyl ester

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study and according to GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

not specified

GLP compliance:

yes

Type of assay:

bacterial gene mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Enbucrilate

EC Number:

229-552-2

EC Name:

Enbucrilate

Cas Number:

6606-65-1

Molecular formula:

C8H11NO2

IUPAC Name:

butyl 2-cyanoacrylate

Constituent 2

Reference substance name:

[TN]1-butyl cyanoacrylate[/TN][SPEC][/SPEC][AM][/AM]

IUPAC Name:

[TN]1-butyl cyanoacrylate[/TN][SPEC][/SPEC][AM][/AM]

Details on test material:

LID-1187A is the code for the trade name Indermil. Indermil is a formulation of 97 % 1-butyl cyanoacrylate (CAS 6606-65-1).

Method

Target gene:

TA 1535, TA 100, TA 1537, TA 98

Species / strain

Species / strain / cell type:

other: S.typhimurium: TA 1535, TA 100, TA 1537, TA98

Metabolic activation:

with and without

Metabolic activation system:

rat liver S9 induced

Test concentrations with justification for top dose:

25 to 2500 µg/plate

Vehicle / solvent:

Acetone

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: sodium azide, 2-aminoanthracene, 9-aminoacridine, 2-nitrofluorene, benzo(a)pyrene

Results and discussion

Test results

Species / strain:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

in all strains at 2500 µg

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

The test materials, LID-1187A and Histoacryl, were devoid of mutagenic activity under the conditions of test.

Executive summary:

LID-1187A and Histoacryl were examined for mutagenic activity in four histidine-dependent auxotrophs of Salmonella typhimurium, strains TA 98, TA 100, TA 1535 and TA 1537, using pour-plate assays. The procedures used complied with OECD Guideline for Testing of Chemicals No. 471 (issued 1983) and EPA Toxic Substances Control Act Test Guideline § 798.5265 (first issued 1985, amended 1987). Each test, in each strain, was conducted on two separate occasions.

The studies, which were conducted in the absence and presence of an activating system derived from rat liver (S-9 mix), employed a range of levels of both test materials from 25 to 2500 µg per plate, selected following a preliminary toxicity test in strain TA 98. All tests included solvent (acetone) controls with and without S-9 mix.

No increases in reversion to prototrophy were obtained with any of the four bacterial strains following exposure to either LID-1187A or Histoacryl at the levels tested, either in the presence or absence of S-9 mix. Inhibition of growth, observed as thinning of the background lawn of non-revertant cells and reduction in revertant colony numbers, occurred in all strains following exposure to both test materials at 2500 ug per plate.

Marked increases in the number of revertant colonies were induced by the known mutagens benzo[a]pyrene, 2-nitrofluorene, 2-aminoanthracene, 9-aminoacridine and sodium azide when examined under similar conditions.

It was concluded that both LID-1187A and Histoacryl were devoid of mutagenic activity under the conditions of the test.