Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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

Currently viewing:

Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
Study period:
04-Apr-1990 to 27-Apr-1990
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
The restrictions were that the range of strains differs from the current guideline

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report date:
1990

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
yes
Remarks:
(no TA102 or E. coli WP2 uvrA; 2-AA only positive control with S9)
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Hexan-1-ol
EC Number:
203-852-3
EC Name:
Hexan-1-ol
Cas Number:
111-27-3
Molecular formula:
C6H14O
IUPAC Name:
hexan-1-ol

Method

Target gene:
Histidine
Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Species / strain / cell type:
S. typhimurium TA 1538
Metabolic activation:
with and without
Metabolic activation system:
Rat liver S9 Aroclor 1254 induced
Test concentrations with justification for top dose:
1st test: 8, 40, 200, 1000 and 5000 µg/plate
2nd test: 6.25, 25, 100, 400 and 1600 µg/plate
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: the test substance was suspended in sorbitan derivative (Tween 80)/water
- Justification for choice of solvent/vehicle: none stated
Controlsopen allclose all
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
sodium azide
Remarks:
TA100, TA1535 without S9
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
9-aminoacridine
Remarks:
TA1537 without S9
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: 4-nitro-o-phenylendiamine in TA98 and TA1538 without S9
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: 2-Aminoanthracene in all strains with S9
Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar (plate incorporation)

DURATION
- Preincubation period: none
- Exposure duration: 48 hours

NUMBER OF REPLICATES
- 3
Evaluation criteria:
Combination of: a) plate background of non-reverted bacteria not showing growth reduction relative to respective negative controls; b) spontaneous mutation rates within historical limits; c) at one or more doses tested the substance causes a 2-fold (TA 100) or 3-fold (other strains) increase in mutation rate above control levels.
Statistics:
None

Results and discussion

Test resultsopen allclose all
Key result
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
5000 µg/plate
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 1538
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
5000 µg/plate
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 1537
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
5000 µg/plate
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
5000 µg/plate
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium 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
Additional information on results:
TEST-SPECIFIC CONFOUNDING FACTORS
None

COMPARISON WITH HISTORICAL CONTROL DATA:
The spontaneous mutation frequencies for untreated and solvent treated cultures were within the historical range for the laboratory for all strains in the absence and in the presence of S9.

Any other information on results incl. tables

No increase in the number of revertants relative to the solvent and negative controls was observed in any strain at any concentration in first and second experiments. The results of the first test are presented in tables 1 and 2 below. The results of the second test, conducted over a smaller range of concentrations, were very similar to the first. Table 1 Experiment 1 Plate incorporation: Number of revertants per plate (mean of 3 plates)

 Strain        TA 98        TA 100        TA 1535
 Concentration  µg/plate  + MA  -MA  Toxicity  + MA  -MA  Toxicity  +MA  -MA  Toxicity
 Negative control  44.3  28.7  no  59.3  78.7  no  5.7 5.7   no
 Solvent control  38.7  35.3  no  58.0  79.3  no  4.0  6.7  no
 5000  7.7  0  yes  9.3  20.3  yes  i pp  i pp  yes
 1000  20.3  5.0  yes  55.0  54.7  no  4.0  4.3  no
 200  35.0  38.0  no  68.3  76.0  no  7.3  4.3  no
 40  39.3  31.7  no  64.0  77.0  no  6.7  4.3  no
 8  34.3  40.0  no  61.7  73.3  no  6.3  4.3  no
 Positive control  791.7  519.0  no  765.0  223.3  no  74.0  213.3  no

i pp: inhibition of background lawn and pin-point colonies

Table 2 Experiment 1 Plate incorporation: Number of revertants per plate (mean of 3 plates)

 Strain        TA 1537        TA 1538
 Concentration  µg/plate  + MA  -MA  Toxicity  + MA  -MA  Toxicity
 Negative control  4.0  3.7  no  15.0  10.0  no
 Solvent control  3.7  3.7  no  12.3  8.0  no
 5000  i pp  4.3  yes  11.3  i pp  no
 1000  3.3  3.3  no  10.3  5.7  yes
 200  4.7  2.3  no  13.0  7.0  no
 40  5.0  5.3  no  13.3  8.0  no
 8  4.0  4.3  no  11.3  8.7  no
 Positive control  269.0  354.0  no  1134.3  884.0  no

Applicant's summary and conclusion

Conclusions:
In a reliable study, the C6 alcohol Lorol C6 98% did not increase the reverse mutation rate in histidine dependent bacterial strains of Salmonella typhimurium at concentrations of up to 5000 µg/plate in the presence or absence of metabolic activation (cytotoxicity observed at 5000 µg/plate). The study was performed in compliance with GLP. Expected results were obtained with negative (buffer) solvent and positive controls. The repeat experiment gave the same results as the initial test.
It is concluded that the test substance is negative for mutagenicity in bacteria under the conditions of the study.