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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:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1996
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well reported study that complies with basic scientific principles. Only one strain reported here to fulfill requirement for all five strains of bacteria to be reported. Only data on E. coli WP2 uvr A reported in this record.
Cross-reference
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
publication
Title:
Re-examination of the mutagenicity of ethylene glycol monobutyl ether to Samonella strain TA97a.
Author:
Gollapudi, B.B., Barber, E.D., Lawlor, T.E. & Lewis, S.A.
Year:
1996
Bibliographic source:
Mutat.Res., 370, 6164.

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Supplier: Dow Chemicals, Midland, MI
Sample identity verified by IR spectroscopy
Purity: 99.04% (by GC-FID) corrected for water content.
Impurities: water 0.35%; peroxides 23ppm

Method

Species / strain
Species / strain / cell type:
E. coli WP2 uvr A
Details on mammalian cell type (if applicable):
National collection of industrial bacteria, Torry Research Station, Scotland
Additional strain / cell type characteristics:
not applicable
Metabolic activation:
with and without
Metabolic activation system:
S9 homogenates prepared from SD rat livers injected with Aroclor 1254
Test concentrations with justification for top dose:
500, 1000, 2500, 5000, 8500, 10000ug/plate
S9 concentrations used: 2.5 and 10%
Controlsopen allclose all
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
4-nitroquinoline-N-oxide
Remarks:
Migrated to IUCLID6: WP2uvrA without S9, 25ug/plate
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: all strains with S9, 2.5ug/plate
Details on test system and experimental conditions:
NUMBER OF REPLICATIONS: 2

Results and discussion

Test results
Species / strain:
E. coli WP2 uvr A
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'.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative with and without metabolic activation.

2-butoxyethanol does not increase the rate of reverse mutations in the baterial strains TA100 and TA97a (S. typhimurium) and WP2uvrA (E. coli)
Executive summary:

2-butoxyethanol, a read across substance for 2 -(2-butoxyethoxy)ethanol, does not increase the rate of reverse mutations in the baterial strain WP2uvrA (E. coli). See attached document in Chapter 13 for full justification for read across.