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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline with acceptable restrictions (limited reporting).

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979
Reference Type:
publication
Title:
In Vitro Mutagenicity and Cell Transformation Screening of Caprolactam.
Author:
Greene, E.J. et al.
Year:
1979
Bibliographic source:
Environ. Mutagen. 1, 399-407

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Caprolactam
- Analytical purity: >99%

Method

Target gene:
Salmonella typhimurium: histidine operon
Species / strain
Species / strain / cell type:
other: Salmonella typhimurium TA 1535, TA 1537, TA 1538, TA 98, TA 100
Metabolic activation:
with and without
Metabolic activation system:
Aroclor 1254 induced liver S9 mix
Test concentrations with justification for top dose:
5000, 10770, 23210 and 50000 µg/plate
Controlsopen allclose all
Negative solvent / vehicle controls:
yes
Positive controls:
yes
Positive control substance:
other: dinitrotoluene (500 μg, TA1535 and TA100), quinacrine mustard (10 μg, TA1537) and nitrofluorene (100 μg, TA1538 and TA98)
Remarks:
without S9
Negative solvent / vehicle controls:
yes
Positive controls:
yes
Positive control substance:
other: anthramine (100 μg, TA1535 and TA 100), aminoquinoline (100 μg, TA1537) and acetamidofluorene (500 μg, TA1538 and TA98)
Remarks:
with S9
Details on test system and experimental conditions:
According to Ames et al. 1975; Mut.Res. 31, 347
Evaluation criteria:
not reported

Results and discussion

Test results
Species / strain:
other: Salmonella typhimurium TA 1535, TA 1537, TA 1538, TA 98, TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other:
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

Mean Reverants per plate (average of 2 plates)

Dose (µg/plate)

        TA 98

       TA 100

      TA 1535

      TA 1537

      TA1538

-S9

+S9

-S9

+S9

-S9

+S9

-S9

+S9

-S9

+S9

0

13

17

54

55

54

52

6

7

8

11

5000

16

20

56

67

52

63

6

8

8

16

10770

15

18

54

66

60

56

4

8

10

16

23210

11

22

57

52

66

61

3

6

11

12

50000

8

16

50

54

56

51

4

8

9

12

Positive control

558

1178

237

242

78

0

122

379

1209

1156

 

Applicant's summary and conclusion