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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:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study (OECD), without GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
no
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): 1,6-Hexandiol
- Test substance No.: 88/484
- Analytical purity: 99%
- Storage condition of test material: 4°C

Method

Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Additional strain / cell type characteristics:
not applicable
Metabolic activation:
with and without
Metabolic activation system:
Aroclor 1254 pretreated rat liver S9 mix
Test concentrations with justification for top dose:
20, 100, 500, 2500, 5000 ug/plate
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: DMSO
Controlsopen allclose all
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: 2-aminoanthracene; 2.5 µg, dissolved in DMSO; for TA 100, TA 98, TA 1537 and TA 1535
Remarks:
with metabolic activation
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: methyl-N'-nitro-N-nitrosoguanidine (MNNG); 5 µg, dissolved in DMSO; for TA 100 and TA 1535
Remarks:
without metabolic activation
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: 4-nitro-o-phenylendiamine; 10 µg, dissolved in DMSO; for TA 98
Remarks:
without metabolic activation
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
9-aminoacridine
Remarks:
without metabolic activation

Migrated to IUCLID6: 100 µg, dissolved in DMSO; for TA 1537
Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar (plate incorporation)

DURATION
- Exposure duration: 48 h, 37°C

NUMBER OF REPLICATIONS: 3

DETERMINATION OF CYTOTOXICITY
- Method: colony number
Evaluation criteria:
In general, a substance to be characterized as positive in the Ames test has to fulfill the following requirements:
- doubling of the spontaneous mutation rate (control)
- dose-response relationship
- reproducibility of the results .

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:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

Results:

Dose µg/plate metabolic activation  TA98   TA100   TA1535   TA1537   TA1537 (2nd experiment) 
Trial 1 Trial 2 Trial 3 Trial 1 Trial 2 Trial 3 Trial 1 Trial 2 Trial 3 Trial 1 Trial 2 Trial 3 Trial 1 Trial 2 Trial 3
0 + 35 31 36 112 116 92 20 25 23 5 8 6 10 9 10
20 + 33 38 32 102 103 92 24 22 23 10 17 16 13 8 9
100 + 28 31 29 89 97 102 30 25 22 13 12 10 8 7 8
500 + 28 31 26 108 92 100 25 28 21 14 10 9 7 8 6
2500 + 27 32 26 122 100 105 20 24 28 10 18 16 5 14 9
5000 + - 31 32 111 115 104 30 32 30 10 10 10 7 8 11
                 
2.5 µg 2-Aminoanthracene + 1230 978 1140 1850 1970 2100 230 240 326 100 101 100 134 152 124
                 
0 - 23 25 20 104 112 108 14 19 20 6 7 7 10 8 8
20 - 18 25 22 102 94 111 16 22 17 8 6 5 12 10 7
100 - 28 23 20 93 86 118 17 26 29 6 7 7 13 8 10
500 - 24 22 21 90 90 102 26 20 22 6 6 6 8 9 10
2500 - 24 25 26 103 98 101 26 28 19 5 5 5 10 11 8
5000 - 18 28 26 109 102 91 16 20 19 6 8 7 11 9 12
                 
5 µg MNNG -   1460 1550 1510 1400 1300 1050      
4 µg 4-Nitro-o-phenylendiamin - 766 812 825            
100 µg 9-Aminoacridiniumchloride monohydrate -                   544 605 703 462 535 571

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative