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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
Type of information:
experimental study
Adequacy of study:
key study
Study period:
24 April 2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report date:
2013

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
Diallyl isophthalate
EC Number:
214-122-9
EC Name:
Diallyl isophthalate
Cas Number:
1087-21-4
Molecular formula:
C14H14O4
IUPAC Name:
1,3-bis(prop-2-en-1-yl) benzene-1,3-dicarboxylate
Test material form:
liquid
Details on test material:
- Name of test material (as cited in study report): Diallyl isophthalate
- Substance type: organic
- Physical state: liquid
- Analytical purity: 99.8%
- Purity test date:
- Lot/batch No.:
- Expiration date of the lot/batch:
- Stability under test conditions:
- Storage condition of test material:
- Other:

Method

Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Species / strain / cell type:
E. coli WP2 uvr A pKM 101
Metabolic activation:
with and without
Metabolic activation system:
S9
Test concentrations with justification for top dose:
Without S9 mix
0, 2.29, 6.86, 20.6, 61.7, 185, 556, 1667 and 5000 µg/plate (all strains: dose determination test)
0, 4.88, 9.77, 19.5, 39.1, 78.1, 156 and 313 µg/plate (TA100: Main test)
0, 1.22, 2.44, 4.88, 9.77, 19.5, 39.1 and 78.1 µg/plate (TA1535: Main test)
0, 39.1, 78.1, 156, 313, 625, 1250, 2500 and 5000 µg/plate (WP2urvA/pKM101: Main test)
0, 2.44, 4.88, 9.77, 19.5, 39.1, 78.1, 156, 313, 625 and 1250 µg/plate (TA98: Main test)
0, 19.5, 39.1, 78.1, 156, 313, 625, 1250 and 2500 µg/plate (TA1537: Main test)
0, 1.22, 2.44, 4.88, 9.77, 19.5, 39.1 and 78.1 µg/plate (TA1535: Main test)
0, 39.1, 78.1, 156, 313, 625, 1250, 2500 and 5000 µg/plate (WP2uvrA/pKM101: Main test 2)

With S9 mix
0, 2.29, 6.86, 20.6, 61.7, 185, 556, 1667 and 5000 µg/plate (all strains: Dose determination test)
0, 39.1, 78.1, 156, 313, 625, 1250 and 2500 µg/plate (TA100, TA1535: Main test)
0, 78.1, 156, 313, 625, 1250, 2500 and 5000 µg/plate (WPurvA/pKM101: Main test)
0, 9.77, 19.5, 39.1, 78.1, 156, 313 and 625 µg/plate (TA98: Main test)
0, 39.1, 78.1, 156, 313, 625,1250 and 2500 µg/plate (TA1537: Main test)
Vehicle / solvent:
Solvent used: DMSO
- Justification for choice of solvent/vehicle:
Controlsopen allclose all
Untreated negative controls:
no
Negative solvent / vehicle controls:
no
True negative controls:
no
Positive controls:
yes
Positive control substance:
9-aminoacridine
sodium azide
Untreated negative controls:
no
Negative solvent / vehicle controls:
no
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: 2-aminoanthracene
Untreated negative controls:
no
Negative solvent / vehicle controls:
no
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: 2-(2-furyl)-3-(5-nitro-2-furyl)acrylamide

Results and discussion

Test resultsopen allclose all
Species / strain:
S. typhimurium TA 98
Metabolic activation:
without
Genotoxicity:
positive
Cytotoxicity / choice of top concentrations:
cytotoxicity
Vehicle controls validity:
not applicable
Untreated negative controls validity:
not examined
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Vehicle controls validity:
not examined
Untreated negative controls validity:
not applicable
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Vehicle controls validity:
not applicable
Untreated negative controls validity:
not examined
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Vehicle controls validity:
not applicable
Untreated negative controls validity:
not examined
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 1537
Metabolic activation:
without
Genotoxicity:
positive
Cytotoxicity / choice of top concentrations:
cytotoxicity
Vehicle controls validity:
not examined
Untreated negative controls validity:
not applicable
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 1537
Metabolic activation:
with
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Vehicle controls validity:
not applicable
Untreated negative controls validity:
not examined
Positive controls validity:
valid
Species / strain:
E. coli WP2 uvr A pKM 101
Metabolic activation:
with
Genotoxicity:
positive
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
not applicable
Untreated negative controls validity:
not examined
Positive controls validity:
valid

Any other information on results incl. tables

Growth inhibition of the bacterial lawn with the chemical (toxicity) was observed in S. typhimurium TA100, TA1535, TA98 and TA1537, with or without metabolic activation.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
positive Genotoxic
positive Cytotoxic

Based on these results, diallyl isophthalate was assessed to be mutagenic (positive) in the reverse mutation test in bacteria under the test conditions.