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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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study (OECD)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report date:
1992

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Qualifier:
according to guideline
Guideline:
EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
GLP compliance:
yes
Remarks:
Department of Toxicology, BASF AG
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Pentane-1,2-diol
EC Number:
226-285-3
EC Name:
Pentane-1,2-diol
Cas Number:
5343-92-0
Molecular formula:
C5H12O2
IUPAC Name:
pentane-1,2-diol
Details on test material:
- Name of test material (as cited in study report): 1,2-Pentanediol
- Test substance No.: 91/369
- Lot/batch No.: 49-0372
- Analytical purity: 99.5%
- Substance type: Colorless liquid
- Date of manufacturing: July 1991
- Storage condition of test material: Room temperature

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: water
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; 4 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


METHOD OF APPLICATION: preincubation

DURATION
- Preincubation period: 20 min, 37°C
- 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 plate incorporation::

Due to a too high spontaneous rate (> 50 his+ revertants) in the experimental part with S-9 mix in the 1st experiment a second study with TA98 was carried out.

Dose µg/plate metabolic activation  TA98   TA100   TA1535   TA1537   TA98 (2nd exp.) 
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 + 59 53 61 128 139 98 18 21 25 17 18 11 45 45 38
20 + 50 57 63 106 133 118 19 23 25 9 13 10 45 45 50
100 + 48 59 41 137 118 123 26 27 20 13 7 14 50 55 52
500 + 57 36 50 119 117 121 17 22 28 14 13 8 53 58 49
2500 + 56 52 49 107 130 109 20 22 27 12 13 12 50 44 46
5000 + 69 47 52 133 116 147 23 18 19 14 15 9 49 46 50
                 
2.5 µg 2-Aminoanthracene + 924 967 1100 1180 1230 1080 284 288 323 91 92 83 542 575 588
                 
0 - 27 26 29 99 135 109 16 25 26 13 14 14 26 20 28
20 - 34 26 28 132 130 144 17 15 20 7 9 11 26 37 28
100 - 26 32 37 127 128 141 25 22 30 6 9 11 33 36 38
500 - 32 26 33 143 126 98 22 16 17 12 7 7 37 35 37
2500 - 25 31 36 97 89 103 20 17 32 8 9 9 33 31 33
5000 - 30 34 25 106 75 79 24 31 17 13 15 10 40 32 34
                 
5 µg MNNG -   974 1015 1230 1320 1380 1600   1100 1210 1060
4 µg 4-Nitro-o-phenylendiamin - 891 861 885            
100 µg 9-Aminoacridiniumchloride monohydrate -                   412 539 734      

Results preincubation:

Dose µg/plate metabolic activation  TA98   TA100   TA1535   TA1537 
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 + 43 46 44 132 111 119 12 19 16 7 12 9
20 + 33 38 36 111 141 129 12 20 14 12 8 14
100 + 33 38 36 121 122 134 154 14 18 10 8 6
500 + 37 41 46 142 132 36 17 16 13 11 11 7
2500 + 49 56 46 132 146 152 18 15 16 6 9 14
5000 + 51 58 48 140 163 144 15 15 12 10 13 15
             
2.5 µg 2-Aminoanthracene + 1030 952 938 956 1010 894 110 156 140 98 102 99
             
0 - 32 28 26 126 114 115 20 14 17 11 9 8
20 - 25 27 25 114 100 108 17 18 15 13 10 4
100 - 31 23 23 105 126 115 13 17 14 13 10 9
500 - 25 30 21 108 121 115 16 16 15 8 11 7
2500 - 27 33 22 132 97 132 18 15 17 9 8 7
5000 - 20 21 23 126 115 119 15 16 19 8 6 11
             
5 µg MNNG -   976 781 699 110 156 140  
4 µg 4-Nitro-o-phenylendiamin - 789 699 746        
100 µg 9-Aminoacridiniumchloride monohydrate -                   456 512 534

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative