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Diss Factsheets
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EC number: 203-910-8 | CAS number: 111-81-9
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in mammalian cells
- 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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Read-across from a Klimisch-1-rated study on mammalian cell gene mutation performed with undecylenic acid. Justification for read-across : This study performed with undecylenic acid is used for read-across to evaluate methyl 10 -undecenoate. This read-across is based on the following justification. Referring to ECHA's "Guidance on information requirements and chemical safety assessment - Chapter R.6: QSARs and grouping of chemicals", endpoint information is read-across from a structural analogue. A structural analogue is a source chemical whose physico-chemical and toxicological properties are likely to be similar to the target chemical as a result of structural similarity. The similarity may be based on a common precursor and/or breakdown product, that results via physical or biological processes (metabolic pathway similarity). This is used to examine related chemicals, such as acid/ester/salt. Since the target chemical methyl-10-undecenoate is the methyl ester of the source chemical undecylenic acid, read-across between the two substances based on structural analogy therefore technically is possible. The scientific justification for the read-across of the study on oral repeat dose toxicity from undecylenic acid to methyl-10 –undecenoate is based on the similiar behaviour of the two substances observed during the six in-vivo studies on acute effects.
Cross-reference
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.17 (Mutagenicity - In Vitro Mammalian Cell Gene Mutation Test)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- mammalian cell gene mutation assay
Test material
- Reference substance name:
- Undecylenic acid
- IUPAC Name:
- Undecylenic acid
- Reference substance name:
- Undec-10-enoic acid
- EC Number:
- 203-965-8
- EC Name:
- Undec-10-enoic acid
- Cas Number:
- 112-38-9
- IUPAC Name:
- undec-10-enoic acid
- Details on test material:
- no data
Constituent 1
Constituent 2
Method
- Target gene:
- hypoxanthine-phosphoribosyl-transferase (HPRT)
Species / strain
- Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Details on mammalian cell type (if applicable):
- - Type and identity of media: DMEM 10% FCS, Pen/Strep/fungizone
- Properly maintained: yes
-obtained as cryopreserved stock from Institute de Recherches Scientifiques sur le Cancer, Villejuif, France
- Metabolic activation:
- with and without
- Metabolic activation system:
- S 9 (from the liver of Arochlor-induced rats)
- Test concentrations with justification for top dose:
- 10, 30, 100, 300, 500, 600 µg/ml
- Vehicle / solvent:
- DMSO
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- N-ethyl-N-nitro-N-nitrosoguanidine
- Remarks:
- Migrated to IUCLID6: and Dimethylnitrosamin with S9
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium; in agar (plate incorporation); preincubation; in suspension; as impregnation on paper disk
DURATION
- Preincubation period:
- Exposure duration: 3 h
- Expression time (cells in growth medium): 6 days
- Selection time (if incubation with a selection agent): 10 days on 6-thioguanine
STAIN (for cytogenetic assays): Giemsa
NUMBER OF REPLICATIONS: 2 studies (6 and 10 replicates/condition, respectively)
DETERMINATION OF CYTOTOXICITY
- Method: cloning efficiency; - Evaluation criteria:
- mutagic if: 3 times mutation frquency of untreated cells + dose-dependent, statistically significant increase in mutation frequency + reproducible in repeat-experiment
- Statistics:
- no data
Results and discussion
Test results
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- up to limit of solubility
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- >= 500 μg/ml in the presenc of S9
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Water solubility: <= 500 μg/ml - 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
According to CLP criteria, no classification of undecylenic acid is required. Therefore it is proposed also not to classify the methyl-10-undeceonate. - Executive summary:
The in vitro mutagenic activity of the test substance undecylenic acid was investigated in the chinese hamster V79/HPRT-test. The test substance was applied to cell cutures at concentrations of 30 -500 µg/ml in the presence or absence of metabolic activation system (S9 -mix). The mutation frequency of treated cell cultures was equal to that of untreated controls, while cell cultures treated with positive controls presented higher mutation frequencies.
Under the described experimental conditions, the test substance undecylenic acid is not mutagenic in the chinese hamster V79/HPRT gene mutation assay.
Justification for read-across:
This robust study summary is a read-across, based on a Klimisch-1-rated mammalian cell gene mutation study on the structural analogue undecylenic acid. For this read-across the following justification is given.
Referring to ECHA's "Guidance on information requirements and chemical safety assessment - Chapter R.6: QSARs and grouping of chemicals", endpoint information is read-across from a structural analogue. A structural analogue is a source chemical whose physico-chemical and toxicological properties are likely to be similar to the target chemical as a result of structural similarity. The similarity may be based on a common precursor and/or breakdown product that results via physical or biological processes (metabolic pathway similarity). This is used to examine related chemicals, such as acid/ester/salt.
Since the target chemical methyl-10-undecenoate is the methyl ester of the source chemical undecylenic acid, read-across between the two substances based on structural analogy therefore technically is possible. The scientific justification for the read-across of the in-vitro cell gene mutation study from undecylenic acid to methyl-10-undecenoate is based on the same behaviour of the two substances observed during other genotoxicity in-vitro studies, which lead for both chemicals to the result “no classification” (see following table). Since furthermore the physical-chemical properties of source and target substance mostly are similar as well, to accepting the above suggested read-across is being proposed.
Methyl-10-undecenoate
(methyl ester of undecylenic acid)
Undecylenic acid
Genetic toxicity in vitro: Ames test
No classification
No classification
Genetic tox. in vitro: chromosome aberration
No classification
No classification
Genetic tox. in vitro: mammalian cell gene mutation test
No classification proposed
Read across from undecylenic acid
No classification
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