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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:
experimental study
Adequacy of study:
key study
Study period:
February 20, 1984 to March 6, 1984
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study carried out prior to GLP, but meets all other requirements
Justification for data waiving:
other:
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report Date:
1984

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
no
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): 1,2-bis(phenoxy)ethane
- Molecular weight (if other than submission substance): 214.25
- Physical state: Colourless crystal at room temperature
- Analytical purity: 99% or more
- Other:
- Melting point: 96°C
- Solubility: Oil-soluble
- Solubility: 5% or more *
* DMSO

Method

Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
Metabolic activation:
with and without
Metabolic activation system:
S9 mix
Test concentrations with justification for top dose:
Concentration (µg/plate): 10, 50, 100, 500, 1000, 5000 with and without S9

Microbial suspension used in test: 0.1 ml
Test substance solutions: 0.1 ml
Sodium phosphate buffer: 0.5 ml
S9 Mix (With metabolic activation): 0.5 ml
Soft agar solution: 2.0 ml
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: DMSO
Controls
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
2-acetylaminofluorene
9-aminoacridine
2-nitrofluorene
sodium azide
Details on test system and experimental conditions:
Source of strains used in test: The Institute of Environmental Toxicology
Date of receipt: 5 August 1979
Storage conditions (-80°C):
- Microbial suspension composition: 0.8 ml
- DMSO composition: 0.07 mL

S9 – Self manufactured on 15 February 1984. For details and composition of S9 mix see attached report

Test method: plating method

Test conditions:
Microbial suspension used in test: 0.1 ml
Test substance solutions: 0.1 ml
Sodium phosphate buffer: 0.5 ml
S9 Mix (With metabolic activation): 0.5 ml
Soft agar solution: 2.0 ml

Incubation Temperature: 3.7 °C
Time: 48 hours
Evaluation criteria:
See attached report
Statistics:
see attahced report

Results and discussion

Test results
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not determined
Vehicle controls validity:
valid
Untreated negative controls validity:
not specified
Positive controls validity:
valid
Additional information on results:
See attached report for results
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

Test substance had no mutagenicity in all strains under the conditions of the study.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

Test substance had no mutagenicity in all strains under the conditions of the study, in the absence or presence of metabolic activation.