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Diss Factsheets
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EC number: 264-092-6 | CAS number: 63310-16-7
- 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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- 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: Scientific justification for addressing the endpoint using data from an analogue substance.
Data source
Reference
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- no guideline required
- Principles of method if other than guideline:
- A review of available data on structural analogues of the registered substance, the results of which are read-across to draw conclusions on the developmental toxicity/teratogenicity potential of the registered substance.
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- Oleic acid, monoester with glycerol
- EC Number:
- 247-038-6
- EC Name:
- Oleic acid, monoester with glycerol
- Cas Number:
- 25496-72-4
- IUPAC Name:
- 2-hydroxy-1-(hydroxymethyl)ethyl octadec-9-enoate
- Reference substance name:
- Glycerol
- EC Number:
- 200-289-5
- EC Name:
- Glycerol
- Cas Number:
- 56-81-5
- Molecular formula:
- C3H8O3
- IUPAC Name:
- glycerol
- Reference substance name:
- Oleic acid
- EC Number:
- 204-007-1
- EC Name:
- Oleic acid
- Cas Number:
- 112-80-1
- Molecular formula:
- C18H34O2
- IUPAC Name:
- octadec-9-enoic acid
- Reference substance name:
- Boric acid
- EC Number:
- 233-139-2
- EC Name:
- Boric acid
- Cas Number:
- 10043-35-3
- Molecular formula:
- H3BO3
- IUPAC Name:
- Boric acid
- Reference substance name:
- 2133-139-2
- IUPAC Name:
- 2133-139-2
- Reference substance name:
- Glycerides, C14-18 and C16-18-unsatd. mono-, di- and tri-
- EC Number:
- 293-187-5
- EC Name:
- Glycerides, C14-18 and C16-18-unsatd. mono-, di- and tri-
- Cas Number:
- 91052-28-7
- IUPAC Name:
- 91052-28-7
- Test material form:
- not specified
- Details on test material:
- CAS 25496-72-4/EC 247-038-6
- Name of test material (as cited in study report): glycerol monooleate
- Molecular formula (if other than submission substance): C21H40O4
- Molecular weight (if other than submission substance): 356.55
- Smiles notation (if other than submission substance): C(=O)(CCCCCCCC=CCCCCCCCC)OC(CO)CO
- Structural formula attached as image file (if other than submission substance): see Fig.1
- Substance type: Organic
CAS 10043-35-3/EC 233-139-2
- Name of test material (as cited in study report): boric acid
- Molecular formula (if other than submission substance): H3O3B
- Molecular weight (if other than submission substance): 61.83
- Smiles notation (if other than submission substance): B(O)(O)O
- Structural formula attached as image file (if other than submission substance): see Fig.
- Substance type: Inorganic
CAS 56-81-5/EC 200-289-5
- Name of test material (as cited in study report): glycerol
- Molecular formula (if other than submission substance): C3H8O3
- Molecular weight (if other than submission substance): 92.10
- Smiles notation (if other than submission substance): C(O)(CO)CO
- Structural formula attached as image file (if other than submission substance): see Fig. 3
- Substance type: Organic
CAS 112-80-1/EC 204-007-1
- Name of test material (as cited in study report): (9Z)-octadecenoic acid
- Molecular formula (if other than submission substance): C18H34O2
- Molecular weight (if other than submission substance): 282.47
- Smiles notation (if other than submission substance): C(=O)(O)CCCCCCCC=CCCCCCCCC
- Structural formula attached as image file (if other than submission substance): see Fig. 4
- Substance type: Organic
CAS 91052-28-7/EC 293-187-5
- Name of test material (as cited in study report): glycerides, C14-18 and C16-18-unsatd. mono-, di- and tri-
- Substance type: Organic
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Constituent 5
Constituent 6
Test animals
- Species:
- other: data is available for rat, mouse, and rabbit for the read across substances
Results and discussion
Results: maternal animals
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 1 other: mL/kg
- Based on:
- test mat.
- Basis for effect level:
- other: developmental toxicity
- Dose descriptor:
- NOEL
- Effect level:
- >= 1 180 - <= 1 310 other: mg/kg/day
- Based on:
- test mat.
- Basis for effect level:
- other: developmental toxicity
Results (fetuses)
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- 9.6 other: mg boron/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- other: teratogenicity
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Read-across to support the registration of 9-Octadecenoic acid (9Z)-, monoester with 1,2,3-propanetriol ester with boric acid using hydrolytic and metabolic breakdown products is considered to be acceptable. None of the data on the hydrolytic and metabolic breakdown products showed these substances to be toxic to development and so 9-Octadecenoic acid (9Z)-, monoester with 1,2,3-propanetriol ester with boric acid is also considered not to be toxic to development.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.