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Toxicological information

Genetic toxicity: in vitro

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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:
supporting study
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:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
not specified
GLP compliance:
yes
Type of assay:
bacterial gene mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
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.