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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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:
experimental study
Adequacy of study:
other information
Study period:
Jan 1993
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: well reported GLP guideline estudy

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report date:
1993

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): rac-5-amino-N-(2,3-dihydroxypropyl)-2,4,6-triiodoisophthalamic acid (ZK 39.211)
- Lot/batch No.: 22028127 K1
- Stable until: Oct 1993

Method

Target gene:
Histidine gene locus
Species / strain
Species / strain / cell type:
other: Salmonella typhimurium TA 1535, TA 100, TA 1537, TA 1538, TA 98
Additional strain / cell type characteristics:
not specified
Metabolic activation:
with and without
Metabolic activation system:
liver mix from Aroclor 1254 -treated rat
Test concentrations with justification for top dose:
Six concentrations tested between 0.1 to 5 mg/plate
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
Positive controls:
yes
Positive control substance:
other: - S9 mix: 2-AA, 2-NF, NaN3; + S9 mix: 2-AA, BP, CP)

Results and discussion

Test results
Species / strain:
other: Salmonella typhimurium TA 1535, TA 100, TA 1537, TA 1538, TA 98
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

Growth inhibition of the background lawn was not observed. There were no precipitates in the agar.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

Tamip monoamide is not mutagenic under the conditions of this test system
Executive summary:

Tamip monoamide (ZK 39211) did not show any mutagenic potential in a bacterial reverse mutation assay with S. typhymurium (TA 1535, TA 100, TA 1537, TA 1538, TA 98) when tested up to 5.0 mg/plate in the absense and presense of intrinsic metabolic activation (liver mix from Aroclor 1254 -treated rats)