Registration Dossier

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Only 4 strains used

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report Date:
1991

Materials and methods

Principles of method if other than guideline:
Method: other: according to OECD TG471, see additionally freetext ME
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
IUCLID4 Test substance: other TS: p-chlorophenylisocyanate, purity: 99.6%

Method

Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Additional strain / cell type characteristics:
not specified
Metabolic activation:
with and without
Metabolic activation system:
S9 mix
Test concentrations with justification for top dose:
(1) 0, 5000, 1000, 200, 40, 8 µg/plate dissolved in EDGE
(2) 0, 12.5, 50, 200, 800, 3200 µg/plate dissolved in EDGE
Vehicle / solvent:
EDGE (Ethylene glycol dimethylether)
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
yes
Positive controls:
yes
Positive control substance:
other: sodium azide, nitrofurantoin, 4-nitro-1,2-phenylene diamine, 2-aminoanthracene
Details on test system and experimental conditions:
IUCLID4 Type: Ames test

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:
other: was not reached due to precipitation
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other:
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

RS-Freetext:
--(1) trial with and without S9-Mix:
precipitation of TS at 5000 µg/plate;
up to 1000 µg/plate: no mutagenic activity
--(2) trial with and without S9-mix:
precipitation of TS at 3200 µg/plate:
up to 800 µg/plate: no mutagenic activity
--positive controls were functional in both trials.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative
Executive summary:

method: Ames test according OECD 471

result: negative