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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1993
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well documented study according to GLP guidelines. No indication if OECD guideline was used, only 4 strains were employed
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

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

Materials and methods

Test guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
yes
Remarks:
only 4 strains were employed
Principles of method if other than guideline:
-
GLP compliance:
yes (incl. QA statement)
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Reference substance name:
Reaction mass of [(4-Ethoxy-3-methyl-4-oxobut-2-en-1-yl](triphenyl)-phosphonium bromide and [(4-Ethoxy-3-methyl-4-oxobut-2-en-1-yl](triphenyl)-phosphonium chloride
IUPAC Name:
Reaction mass of [(4-Ethoxy-3-methyl-4-oxobut-2-en-1-yl](triphenyl)-phosphonium bromide and [(4-Ethoxy-3-methyl-4-oxobut-2-en-1-yl](triphenyl)-phosphonium chloride

Method

Species / strain
Species / strain / cell type:
S. typhimurium, other: TA97, TA98, TA100 and TA102
Additional strain / cell type characteristics:
other: rfa, delta-uvrB, pKM101, pAQ1
Metabolic activation:
with and without
Metabolic activation system:
S9
Test concentrations with justification for top dose:
0, 50, 166, 500, 1666, 5000 ug/plate
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
yes
Positive controls:
yes
Positive control substance:
2-nitrofluorene
sodium azide
mitomycin C
other: ICR 191, 2- Aminoanthracene

Results and discussion

Test results
Species / strain:
S. typhimurium, other: TA97, TA98, TA100 and TA102
Metabolic activation:
with and without
Genotoxicity:
negative
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'.

Any other information on results incl. tables

-

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

neither Wittigesterhalogenid per se, nor any of the metabolites formed under the described experimental conditions is
mutagenic in the Ames tester strains TA97, TA98, TA100 and TA102.
Executive summary:

A standard as well as a preincubation modification assay in absence and in presence of a exogenous metabolic

activation system (S9 mix) were perfomed. The four plasmid bearing tester strains TA97, TA98, TA100 and TA102 were employed. Responsiveness of the strains and activity of the S9 mix were demonstrated by including recommended positive controls in parallel to each experiment.

Wittigesterhalogenid was dissolved in dimethylsulfoxide (DMSO). The dose range 50 to 5’000 ug/plate, the generally recommended highest test concentration for non toxic compounds was evaluated. No precipitation of the compound was observed up to the chosen maximum test concentration. Toxic effects were only obtained in the preincubation modification assay starting at 500 ug/plate (TA102;-S9).

No toxic effects were observed in the standard plate incorporation assay. Wittigesterhaolgenid did not induce an incease in the number of revertant colonies.