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Diss Factsheets

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information
Salmonella/microsome test (Ames test): negative with strains TA 98, TA 100, TA 102 and TA 1535 and TA 1537 (+/- S9 mix)
Link to relevant study records
Reference
Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
Deviations:
no
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay
Target gene:
Histidine gene locus
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
Additional strain / cell type characteristics:
not applicable
Metabolic activation:
with and without
Metabolic activation system:
Aroclor 1254 induced male rat liver S9 mix
Test concentrations with justification for top dose:
0, 50, 158, 500, 1581, 5000 µg/plate and µg/tube (+/-S9 mix, all strains)








Vehicle / solvent:
deionized water
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: sodium azide (only TA 1535), nitrofurantoin (only TA 100), 4-nitro-1,2-phenylene diamine (TA 1537 and TA 98), cumene hydroperoxide (only TA 102), 2-aminoanthracene.
Remarks:
The positive controls sodium azide, nitrofurantoin, 4-nitro-1,2-phenylene diamine and cumene hydroperoxide were only used without S9 mix; the positive control 2-aminoanthracene was only used with S9 mix.
Details on test system and experimental conditions:
METHOD: Standard plate test and preincubation test; each concentration including the controls was tested in triplicate.
Evaluation criteria:
A reproducible and dose-related increase in mutant counts of at least one strain is considered to be a positive result. For TA 1535, TA 1537, TA 100 and TA 98 this increase should be about twice that of negative controls. For TA 102 an increase of about 100 mutants should be reached. Otherwise, the result is evaluated as negative. However, these criteria may be overruled by good scientific judgment. In case of questionable results, investigations should continue, possibly with modifications, until a final evaluation is possible.
Statistics:
not specified
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
weak strain-specific bacteriotoxic effect at 5000 µg/plate, however this dose could nevertheless be used for assessment purposes
Vehicle controls validity:
valid
Untreated negative controls validity:
not applicable
Positive controls validity:
valid
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Table 1: Summary of results from the Salmonella mutagenicity assay with Ethoxyamidin without S9 mix (mean values of revertants per plate)

 Dose (µg per plate)

Without metabolic activation

 

TA 1535

 TA 100

 TA 1537

 TA 98

 TA 102

0

8

81

8

31

182

50

7

80

9

33

156

158

8

72

7

39

166

500

10

83

8

36

180

1581

8

74

7

33

186

5000

10

76

8

30

189

 Positive control

704

198

145

173

346 

 Dose ( µg per tube)

Without metabolic activation

 

TA 1535

 TA 100

 TA 1537

 TA 98

TA 102

0

12

95

9

23

258

50

10

115

11

20

278

158

13

107

9

23

255

500

17

89

10

26

247

1581

13

111

10

19

254

5000

12

99

9

18

244

 Positive control

818

255

163

189

592

Table 2: Summary of results from the Salmonella mutagenicity assay with Ethoxyamidin with S9 mix (mean values of revertants per plate)

Dose (µg per plate)

With metabolic activation (liver S9 mix)

 

TA 1535

 TA 100

 TA 1537

 TA 98

 TA 102

0

12

107

11

39

253

50

10

88

8

41

277

158

12

113

7

45

295

500

10

107

11

37

284

1580

11

100

8

45

258

5000

11

102

10

34

282

 Positive control

317

1702

397

1820

490

 Dose ( µg per tube)

With metabolic activation (liver S9 mix)

 

TA 1535

 TA 100

 TA 1537

 TA 98

TA 102

0

18

112

13

30

338

50

12

113

13

33

319

158

11

104

12

37

345

500

14

113

14

35

346

1580

11

113

12

35

329

5000

12

105

12

33

296

 Positive control

275

1640

334

1513

546 

 

 

Doses up to and including 1580 µg per plate did not cause any bacteriotoxic effects. Total bacteria counts remained unchanged and no inhibition of growth was observed. At 5000 µg the substance had a weak strain-specific bacteriotoxic effect, not limiting evaluation.

No evidence of mutagenic activity was seen in any tester strain with and without metabolic activation.

The positive controls sodium azide, nitrofurantoin, 4-nitro-1,2-phenylene diamine, cumene hydroperoxide 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.

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

The mutagenic potential of Butanoylanilin was evaluated in a Salmonella/microsome test with the S. typhimurium strains TA 98, TA 100, TA 102, TA 1535 and TA 1537 in the presence and absence of S9 mix according to OECD TG 471. Doses up to and including 1580 µg per plate did not cause any bacteriotoxic effects. At 5000 µg/plate a weak strain-specific bacteriotoxic effect occurred, which however did not affect assessment purposes. No evidence of mutagenic activity was seen in the treated cultures with and without S9 -mix. Thus, the test item can be considered as non- mutagenic in the Ames Test.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Additional information

Additional information from genetic toxicity in vitro:

The mutagenic potential of Butanoylanilin was evaluated in a Salmonella/microsome test with the S. typhimurium strains TA 98, TA 100, TA 102, TA 1535 and TA 1537 in the presence and absence of S9 mix according to OECD TG 471.Doses up to and including 1580 µg per plate did not cause any bacteriotoxic effects. At 5000 µg/plate a weak strain-specific bacteriotoxic effect occurred, which however did not affect assessment purposes. No evidence of mutagenic activity was seen in the treated cultures with and without S9 -mix. Thus, the test item can be considered as non- mutagenic in the Ames Test.


Justification for selection of genetic toxicity endpoint
Only one study available

Justification for classification or non-classification

Based on the study results a classification according to Directive 67/548/EEC or Regulation (EC) No. 1272/2008 (CLP) is not warranted.