Registration Dossier
Registration Dossier
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EC number: 291-751-5 | CAS number: 90474-13-8
Toxicological information
Genetic toxicity: in vitro
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:
- 2003-02-03 to 2003-03-02
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Diethyl 1,2-cyclopentanedicarboxylate
- EC Number:
- 291-751-5
- EC Name:
- Diethyl 1,2-cyclopentanedicarboxylate
- Cas Number:
- 90474-13-8
- Molecular formula:
- C11H18O4
- IUPAC Name:
- 1,2-diethyl cyclopentane-1,2-dicarboxylate
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): 852 diester
- Physical state: liquid
- Analytical purity: no data
- Impurities (identity and concentrations): no data
- Lot/batch No.: op 37/03/F32/GP3
Constituent 1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- E. coli WP2 uvr A pKM 101
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-mix 10%
- Test concentrations with justification for top dose:
- 50, 150, 500, 1500, 5000 microg
- Vehicle / solvent:
- Ethanol
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- 100 microlitre
- Negative solvent / vehicle controls:
- yes
- Remarks:
- 10 microlitre
- True negative controls:
- not specified
- Positive controls:
- yes
- Remarks:
- 50 microgramme pour 10 microlitre
- Positive control substance:
- other: Beta-propiolactone
- Remarks:
- TA1535
- Untreated negative controls:
- yes
- Remarks:
- 100 microlitre
- Negative solvent / vehicle controls:
- yes
- Remarks:
- 10 microlitre
- True negative controls:
- not specified
- Positive controls:
- yes
- Remarks:
- 1 microgramme pour 10 microlitre
- Positive control substance:
- other: 2-Anthramine
- Remarks:
- TA1535
- Untreated negative controls:
- yes
- Remarks:
- 100 microlitre
- Negative solvent / vehicle controls:
- yes
- Remarks:
- 10 microlitre
- True negative controls:
- not specified
- Positive controls:
- yes
- Remarks:
- 50 microgramme pour 20 microlitre
- Positive control substance:
- 9-aminoacridine
- Remarks:
- TA1537
- Untreated negative controls:
- yes
- Remarks:
- 100 microlitre
- Negative solvent / vehicle controls:
- yes
- Remarks:
- 20 microlitre
- True negative controls:
- not specified
- Positive controls:
- yes
- Remarks:
- 2 microgramme pour 20 microlitre
- Positive control substance:
- other: 2-Anthramine
- Remarks:
- TA1537
- Untreated negative controls:
- yes
- Remarks:
- 100 microlitre
- Negative solvent / vehicle controls:
- yes
- Remarks:
- 20 microlitre
- True negative controls:
- not specified
- Positive controls:
- yes
- Remarks:
- 2 microgramme pour 20 microlitre
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- TA98
- Untreated negative controls:
- yes
- Remarks:
- 100 microlitre
- Negative solvent / vehicle controls:
- yes
- Remarks:
- 20 microlitre
- True negative controls:
- not specified
- Positive controls:
- yes
- Remarks:
- 2 microgramme pour 20 microlitre
- Positive control substance:
- other: 2-Anthramine
- Remarks:
- TA98
- Untreated negative controls:
- yes
- Remarks:
- 100 microlitre
- Negative solvent / vehicle controls:
- yes
- Remarks:
- 20 microlitre
- True negative controls:
- not specified
- Positive controls:
- yes
- Remarks:
- 20 microgramme pour 20 microlitre
- Positive control substance:
- sodium azide
- Remarks:
- TA100
- Untreated negative controls:
- yes
- Remarks:
- 100 microlitre
- Negative solvent / vehicle controls:
- yes
- Remarks:
- 20 microlitre
- True negative controls:
- not specified
- Positive controls:
- yes
- Remarks:
- 2 microgramme pour 20 microlitre
- Positive control substance:
- other: 2-Anthramine
- Remarks:
- TA100
- Untreated negative controls:
- yes
- Remarks:
- 100 microlitre
- Negative solvent / vehicle controls:
- yes
- Remarks:
- 10 microlitre
- True negative controls:
- not specified
- Positive controls:
- yes
- Remarks:
- 1 microgramme pour 10 microlitre
- Positive control substance:
- other: Cis-platinum (II) diamine dihydrochloride
- Remarks:
- E. coli
- Untreated negative controls:
- yes
- Remarks:
- 100 microlitre
- Negative solvent / vehicle controls:
- yes
- Remarks:
- 5 microlitre
- True negative controls:
- not specified
- Positive controls:
- yes
- Remarks:
- 5 microgramme pour 5 microlitre
- Positive control substance:
- 9,10-dimethylbenzanthracene
- Remarks:
- E. coli
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A pKM 101
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- La comparaison entre les valeurs obtenues pour les réversions spontanées, et pour les témoins positifs, sans et avec activation métabolique, et la moyenne des valeurs expérimentales "historiques" obtenues au laboratoire ne fait pas apparaître de différences significatives.
Aucune augmentation du nombre de revertants n'a été mise en évidence en présence des différentes concentrations du produit (5 000, 1 500, 500, 150, 50 microgrammes par boîte), en absence ou en présence d'activation métabolique, pour les souches Salmonella typhimurium TA 1535, TA 1537, TA 98, TA 100 et la souche Escherichia coli WP2 (pKM 101) (uvr A).
La toxicité du produit à la concentration de 5 000 microgrammes par boîte a évidemment pour conséquence une diminution significative du nombre de revertants sans et avec activation métabolique. La dose de 1 500 microgrammes par boîte induit également pour les souches TA 1535, TA 1537, TA 98 et E. Coli une diminution significative du nombre de revertants.
En conclusion: le produit à tester, 852 diester op 37/03/F32/GP3, fourni par la société ORIL INDUSTRIES ne présente pas d'activité mutagène vis à vis des quatre souches de Salmonella typhimurium (TA 1535, TA 1537, TA 98 et TA 100) et d'une souche Escherichia coli (WP2) (pKM 101) (uvr A), sans et avec activation métabolique.
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