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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: No OECD Guideline defined.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
not specified
Remarks:
only 4 test strains used
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
3-chlorophenyl isocyanate
EC Number:
220-822-5
EC Name:
3-chlorophenyl isocyanate
Cas Number:
2909-38-8
Molecular formula:
C7H4ClNO
IUPAC Name:
1-chloro-3-isocyanatobenzene
Details on test material:
purity: 99.8%, clear liquid, molecular weight: 153.6

Method

Target gene:
Ames assay
Species / strain
Species / strain / cell type:
other: Salmonella typhimurium TA 98, TA 100, TA 1535, TA 1537
Metabolic activation:
with and without
Metabolic activation system:
S9
Test concentrations with justification for top dose:
up to 8 µg per plate
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
not specified
True negative controls:
yes
Positive controls:
yes
Positive control substance:
other: sodium azide, nitrofurantoin, 4-nitro-1.2-phenylene diamine and 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:
not specified
Vehicle controls validity:
not specified
Untreated negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: other: S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

Summary of the results with the test substance in the Salmonella/ Microsome Test

 S9 mix  TA 1535  TA 100  TA 1537  TA 98
 without  negative   negative   negative   negative
 with   negative   negative   negative   negative

Applicant's summary and conclusion

Executive summary:

The test substance was investigated using the Salmonella/ microsome test for point mutagenic effects in doses up to 5000 µg per plate on four Salmonella typhimurium LT2 mutants. These comprised the histidine-auxotrophic strains TA 1535, TA 100, TA 1537 and TA 98.

Doses up to and including 8 µg per plate did not cause any bacteriotoxic effects: Total bacteria counts remained unchanged and no inhibition of growth was observed. At higher doses, the substance had a strong, strain-specific and S9 -dependent bacteriotoxic effect, so that this range could only be used to a limited extent up to 200 µg per plate (without S9 mix) and 1000 µg per plate (with S9 mix) for assessment purposes. Substance precipitation occured at 1000 µg per plate and above.

The positive controls sodium azide, nitrofurantoin, 4 -nitro-1,2 -phenylene diamine and 2 -aminoanthracene had a marked mutagenic effect, as was seen by a biologically relevant increase in mutant colonies compared to the corresponding negative controls.

Evidence of mutagenic activity of the test substance was not seen.

No biologically relevant increase in the mutant count, in comparison with the negative controls, was observed. Therefore the test substance was considered to be non-mutagenic without and with S9 mix in the Salmonella/ microsome test.