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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Type of information:
experimental study
Adequacy of study:
key study
Study period:
01 Sep - 20 Dec 2005
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report date:
2005

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
2-amino-2',5-dichlorobenzophenone
EC Number:
220-985-2
EC Name:
2-amino-2',5-dichlorobenzophenone
Cas Number:
2958-36-3
Molecular formula:
C13H9Cl2NO
IUPAC Name:
4-chloro-2-(2-chlorobenzoyl)aniline
Test material form:
solid: particulate/powder

Method

Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
Metabolic activation:
with and without
Metabolic activation system:
S9 mix (rat)
Test concentrations with justification for top dose:
Plate incorporation method without metabolic activation [µg/plate]:
0.5, 1, 5, 10, 50, 100, 500, 1000, 5000 S. typhimurium TA 1535 and TA 1537
1, 5, 10, 50, 100, 500, 1000, 5000 S. typhimurium TA 98 and E. coli WP2uvrA
0.1, 0.5, 1, 5, 10, 50, 100, 500, 1000, 5000 S. typhimurium TA 100

Plate incorporation method with metabolic activation [µg/plate]:
0.5, 1, 5, 10, 50, 100, 500 S. typhimurium TA 1535 and TA 1537
0.5, 1, 5, 10, 50, 100, 500, 1000 S. typhimurium TA 98
0.1, 0.5, 1, 5, 10, 50, 100 S. typhimurium TA 100
1, 5, 10, 50, 100, 500, 1000 S. typhimurium E. coli WP2uvrA

Pre-incubation method without metabolic activation [µg/plate]:
0.5, 1, 5, 10, 50, 100, 500 S. typhimurium TA 1535
0.05, 0.1, 0.5, 1, 5, 10, 50 S. typhimurium TA 1537
0.1, 0.5, 1, 5, 10, 50, 100 S. typhimurium TA 98
0.1, 0.5, 1, 5, 10 S. typhimurium TA 100
1, 5, 10, 50, 100 E. coli WP2uvrA

Pre-incubation method with metabolic activation [µg/plate]:
0.5, 1, 5, 10, 50, 100 S. typhimurium TA 1535
0.05, 0.1, 0.5, 1, 5, 10 S. typhimurium TA 1537
0.1, 0.5, 1, 5, 10, 50 S. typhimurium TA 98
0.1, 0.5, 1, 5, 10, 50 S. typhimurium TA 100
1, 5, 10, 50, 100, 500, 1000 E. coli WP2uvrA

Vehicle / solvent:
Concurrent untreated and vehicle ( dimethyl sulfoxide) controls were performed.
Controlsopen allclose all
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
Remarks:
sterile deionised water
True negative controls:
no
Positive controls:
yes
Remarks:
5.0 µg/plate
Positive control substance:
sodium azide
Remarks:
TA 1535 and TA 100
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
Remarks:
dimethyl sulfoxide
True negative controls:
no
Positive controls:
yes
Remarks:
100 µg/plate
Positive control substance:
9-aminoacridine
Remarks:
TA 1537
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
Remarks:
dimethyl sulfoxide
True negative controls:
no
Positive controls:
yes
Remarks:
5.0 µg/plate
Positive control substance:
2-nitrofluorene
Remarks:
TA98
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
Remarks:
sterile deionised water
True negative controls:
no
Positive controls:
yes
Remarks:
1.3 µg/plate
Positive control substance:
methylmethanesulfonate
Remarks:
WP2uvrA
Details on test system and experimental conditions:
METHOD OF APPLICATION: 1st main experiment: in agar (plate incorporation); 2nd main experiment: preincubation

DURATION
- 1st main experiment: 48 hours incubation (37°C)
- 2nd main experiment: 20 min preincubation (37°C), 48 hours incubation (37°C)

NUMBER OF REPLICATIONS: 3

DETERMINATION OF CYTOTOXICITY
- Method: determination of background lawn
Evaluation criteria:
VALIDITY CRITERIA:
- negative controls in the laboratory historical control range (range of spontaneous reversion frequencies)
- positive controls show a distinct enhancement in all tester strains within laboratory historical range
- corresponding background growth on both negative control and test plates should be observed
- selected dose range should include a clearly toxic concentration or should exhibit limited solubility

CRITERIA FOR POSITIVE RESPONSE:
A test is considered to be positive if the test item induces dose related increases in numbers of revertants scored in two separate experiments and these
increases are deemed to be of biological relevance. Reproducible increases at one experimental point may also be indicative of a positive response. For a
biologically relevant response the number of revertants 1s expected to be at least the double of the spontaneaus reversion.

Results and discussion

Test results
Species / strain:
other: S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
at higher concentrations
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
valid

Any other information on results incl. tables

Bacteria
tester
strain		 MA Exp. Mean numbers of revertants per plate Evaluation
Controls µg test item per plate
UTC VC PC 5000 1000 500 100 50 10 5 1 0.5 0.1 0.05
Salmonella typhimurium
TA 1535 no 1st 30.7  28.3  1864.0  14.3 15.3 19.3 117.3 25.3 21.3 n.e. n.e. n.e. n.e. n.e. -
no 1st_a 17.3 21.3 2621.3 n.e. n.e. n.e. n.e. n.e. n.e. 16.3 16.0 14.7 n.e. n.e. -
no 2nd 17.7 21.7 1842.0 n.e. n.e. ** ** 19.7 18.7 22.0 20.0 20.7 n.e. n.e. -
yes 1st 25.7 28.3 514.0 n.e. n.e. 26.7 28.7 24.3 23.3 27.3 32.0 33.3 n.e. n.e. -
yes 2nd 23.0 18.0 339.3 n.e. n.e. n.e. 24.0 23.0 26.7 24.3 29.3 23.7 n.e. n.e. -
TA 1537 no 1st 16.7 13.0 2630.0 no bg. no bg. no bg. ** 10.7 19.3 n.e. n.e. n.e. n.e. n.e. -
no 1st_a 9.3 11.3 772.0 n.e. n.e. n.e. n.e. n.e. n.e. 9.0 9.0 13.0 n.e. n.e. -
no 2nd 16.3 15.7 1250.0 n.e. n.e. n.e. n.e. no bg. no bg. 14.7 11.0 13.3 n.e. n.e. -
no 2nd_a 13.3 11.3 656.7 n.e. n.e. n.e. n.e. n.e. n.e. n.e. n.e. n.e. 14.0 13.7 -
yes 1st 14.0 16.7 217.0 n.e. n.e. no bg. ** 16.7 15.0 23.7 13.3 14.3 n.e. n.e. -
yes 2nd 23.7 19.7 301.3 n.e. n.e. n.e. n.e. n.e. 29.0 21.0 22.0 22.0 26.0 21.0 -
TA 98 no 1st 32.0 26.7 511.3 no bg. no bg. no bg. 24.3 27.3 24.3 n.e. n.e. n.e. n.e. n.e. -
no 1st_a 29.3 25.3 354.7 n.e. n.e. n.e. n.e. n.e. n.e. 22.0 22.7 n.e. n.e. n.e. -
no 2nd 67.0 50.0 642.7 n.e. n.e. n.e. 19.0 23.3 46.7 53.3 51.7 n.e. n.e. n.e. -
no 2nd_a 30.7 26.0 409.3 n.e. n.e. n.e. n.e. n.e. n.e. n.e. n.e. 18.7 24.3 n.e. -
yes 1st 40.3 30.7 4498.0 n.e. ** ** ** 36.3 37.3 43.7 39.3 n.e. n.e. n.e. -
yes 1st_a 27.7 24.0 4386.7 n.e. n.e. n.e. n.e. n.e. n.e. n.e. n.e. 26.3 n.e. n.e. -
yes 2nd 37.7 33.7 3528.0 n.e. n.e. n.e. n.e. 41.0 40.3 44.3 46.0 38.7 45.0 n.e. -
TA 100 no 1st 1177.3 160.0 2016.0 no bg. 36.7 94.0 118.7 109.3 166.3 n.e. n.e. n.e. n.e. n.e. -
no 1st_a 162.0 162.0 2917.3 n.e. n.e. n.e. n.e. n.e. n.e. 168.7 187.3 185.3 170.3 n.e. -
no 2nd 211.7 184.3 1992.0 n.e. n.e. n.e. n.e. n.e. 156.3 177.0 175.0 150.0 156.0 n.e. -
yes 1st 187.0 176.3 4154.0 n.e. n.e. n.e. 112.7 196.0 195.7 189.3 195.7 188.3 175.7 n.e. -
yes 2nd 169.0 160.0 2624.0 n.e. n.e. n.e. n.e. 142.7 173.0 175.3 182.3 172.3 165.3 n.e. -
Escherichia coli
WP2uvrA no 1st 30.3 33.7 272.7 no bg. 13.7 16.0 26.3 28.3 29.7 n.e. n.e. n.e. n.e. n.e. -
no 1st_a 34.3 35.7 332.0 n.e. n.e. n.e. n.e. n.e. n.e. 36.0 33.3 n.e. n.e. n.e. -
no 2nd 25.3 24.3 475.3 n.e. n.e. n.e. 20.0 23.7 27.7 24.3 26.0 n.e. n.e. n.e. -
yes 1st 32.3 36.0 1242.7 n.e. 16.7 27.3 48.3 39.7 36.7 41.0 33.0 n.e. n.e. n.e. -
yes 2nd 30.0 26.3 855.3 n.e. 17.7 20.3 39.0 43.7 43.0 31.3 32.3 n.e. n.e. n.e. -

** instead of the normal background a lot of small bacteria colonies were observed as a sign of an incipient cytotoxicity, scored colonies can not be evaluated

Bacteria Without metabolic activation With metabolic activation
Negative control Positive control Negative control Positive control
X ± sd n X ± sd n X ± sd n X ± sd n
TA 98 24.3 7.2 235 770 323 110 30.4 7.7 246 2815 1318 116
TA 100 184.8 43.0 237 1621 507 114 198.1 46.5 232 3183 1083 108
TA 1535 15.7 5.3 231 1438 479 111 18.3 17.3 224 240 84 103
TA 1537 13.2 4.5 228 2990 1386 107 14.2 4.4 222 372 182 102
WP2uvrA 24.2 5.8 140 307 106 69 28.5 6.7 134 218 158 66

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

Based on the results of the reported study it is concluded that ADB does not induce gene mutation in Salmonella typhimurium and Escherichia coli under the
experimental conditions described. Therefore, ADB is considered to be non-motagenie in the bacterial reverse mutation test.