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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
Study period:
March 2004 - May 2004
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report Date:
2004

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
yes (incl. certificate)
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
Read across data is presented from the structurally related substance, 1,1'-Bis(ferrocenyl)octane, CAS Number 501410-94-2, EC Number 479-710-1. This substance bears a close similarity to 1,1''-isopropylidenediferrocene, CAS Number 12609-95-9, EC Number 235-719-0, the distinction being that the alkyl bridging functionality between the two ferrocene moieties is an octyl derivative as opposed to an isopropyl derivative.

Method

Species / strain
Species / strain:
other: sat TA 98, 100, 1535, 1537; esc WP2 uvrA
Metabolic activation:
with and without
Metabolic activation system:
S9-Mix (Phenobarbital and beta-Naphthoflavone.
Test concentrations with justification for top dose:
Concentration range in the main test (with metabolic activation): 31.62 100.00, 316.20, 1000.00, 2500.00 and 5000 µg/plate
Concentration range in the main test (without metabolic activation): 31.62 100.00, 316.20, 1000.00, 2500.00 and 5000 µg/plate
Vehicle:
Solvent: Acetone

Results and discussion

Test resultsopen allclose all
Species / strain:
other: sat TA 98, 100, 1535, 1537; esc WP2 uvrA
Metabolic activation:
with
Cytotoxicity:
yes
Remarks:
> 5000 µg/plate
Remarks on result:
other: Preliminary test
Remarks:
Migrated from field 'Test system'.
Species / strain:
other: sat TA 98, 100, 1535, 1537; esc WP2 uvrA
Metabolic activation:
without
Cytotoxicity:
yes
Remarks:
> 5000 µg/plate
Remarks on result:
other: Preliminary test.
Remarks:
Migrated from field 'Test system'.
Species / strain:
other: sat TA 98, 100, 1535, 1537; esc WP2 uvrA
Metabolic activation:
with
Cytotoxicity:
yes
Remarks:
> 5000 µg/plate
Remarks on result:
other: Main test.
Remarks:
Migrated from field 'Test system'.
Species / strain:
other: sat TA 98, 100, 1535, 1537; esc WP2 uvrA
Metabolic activation:
without
Cytotoxicity:
yes
Remarks:
> 5000 µg/plate
Remarks on result:
other: Main test
Remarks:
Migrated from field 'Test system'.
Additional information on results:
Observations:
After 48 hours incubation microdrops (not precipitate) could be observed as colloidical chemical phenomenon at the concentrations of 5000.00 and 2500.00 µg/plate.

Applicant's summary and conclusion

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

According to OECD 471, 1,1'-Bis(ferrocenyl)octane is not mutagenic
Executive summary:

The mutagenicity potential of 1,1'-Bis(ferrocenyl)octane, CAS Number 501410-94-2, EC Number 479-710-1was investigated in accordance with the standardised guideline OECD 471 (Ames test).

An OECD 471 (Ames test) study conducted to GLP in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results was performed on 1,1'-Bis(ferrocenyl)octane, CAS Number 501410-94-2, EC Number 479-710-1.

The study was assigned a reliability score of 1 in accordance with the criteria for assessing data quality set forth by Klimisch et al. (1997).

This substance is considered to be sufficiently close in structural integrity to 1,1''-isopropylidenediferrocene, CAS Number 12609-95-9, EC Number 235-719-0 so as to justify valid read across.

Under the conditions of the study 1,1'-Bis(ferrocenyl)octane was found to be non-mutagenic both with and without metabolic activation.