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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: EEC B.13 OECD 471
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Method

Species / strain
Species / strain / cell type:
bacteria, other: S.Thyphimurium strain TA1535, TA 1537, TA 98, TA 100 and TA1 02
Test concentrations with justification for top dose:
Concentration range in the main test (with metabolic activation): 50 ... 5000 µg/plate
Concentration range in the main test (without metabolic activation): 50 ... 5000 µg/plate
Vehicle / solvent:
Solvent: DMSO
Details on test system and experimental conditions:
Metabolic activation system: Animals

Species: rat

Sex: male

Straom: Sprangue Dawley OFA

Origin: IFFA CREDO (Saint-Germain-sur-l'Arbresle France)

Age and weight: 7 to 8 weeks (180-200 g)


Induction

Enzymatic induction is provoked 5 days before sacrifice by a
single intraperitoneal injection of Aroclor 1254 at a dose
of 500 mg/Kg in the form of a solution in corn oil at 200
mg/ml.


S9 preparation

All stages of the preparation are carried out in a sterile
environment, with laminar flow at 0-4°C.

After animal sacrifice the livers are removed and washed in
a 0.15 M KCL solution, then weighed and cut up, and 0.15 M
KCL is added (the volume of KCl in ml is equivalent to 3
times the weight of the liver in grams). The livers are
homogenized with the help of a Potter, then centrifuged at
9000 x g for 10 minutes. The supernatant is aliquoted,
frozen and preserved in liquid nitrogen.

Results and discussion

Test resultsopen allclose all
Species / strain:
other: as specified above
Metabolic activation:
with
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
( 5000 µg/plate)
Species / strain:
other: as specified above
Metabolic activation:
without
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
( 5000 µg/plate)
Additional information on results:
Observations:
The preliminary (first) test was a standard plate
incorporation assay; the main (second) test involved a pre-
incubation stage.
Remarks on result:
other: other: preliminary test
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

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