Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Constituent 1
Chemical structure
Reference substance name:
4-chlorophenyl isocyanate
EC Number:
203-176-9
EC Name:
4-chlorophenyl isocyanate
Cas Number:
104-12-1
Molecular formula:
C7H4ClNO
IUPAC Name:
1-chloro-4-isocyanatobenzene
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: other: Salmonella typhimurium TA 98, TA 100, TA1535, TA 1537
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