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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report date:
2000

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
Batilol
EC Number:
208-874-7
EC Name:
Batilol
Cas Number:
544-62-7
Molecular formula:
C21H44O3
IUPAC Name:
3-(octadecyloxy)propane-1,2-diol
Test material form:
solid: particulate/powder

Method

Target gene:
uvrB
Species / strain
Species / strain / cell type:
other: TA97a, TA98, TA100, TA102, TA1535
Metabolic activation:
with and without
Metabolic activation system:
S9 mix
Test concentrations with justification for top dose:
1; 1.5; 2 and 2.5mg/ml of DMSO
Vehicle / solvent:
DMSO
Controls
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
sodium azide
benzo(a)pyrene
mitomycin C
other: for strain TA97a, without metabolic activation: ICR 191; for strain TA98, without metabolic activation: 2,4,7-trinitro-9-fluorénone

Results and discussion

Test results
Species / strain:
other: TA97a, TA98, TA100, TA102, TA1535
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
valid
Untreated negative controls validity:
not applicable
Positive controls validity:
valid

Applicant's summary and conclusion

Executive summary:

The substance wasn't genotoxic in an AMES test (OECD 471) on the strains TA97a, TA98, TA100, TA102, TA1535, with and without metabolica activation.