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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

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
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
no
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Hexane-1,6-diol
EC Number:
211-074-0
EC Name:
Hexane-1,6-diol
Cas Number:
629-11-8
Molecular formula:
C6H14O2
IUPAC Name:
hexane-1,6-diol
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