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Diss Factsheets
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EC number: 208-011-4 | CAS number: 505-52-2
- 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
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Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
In a reproductive/developmental screening test (oral administration of 50; 100; 1000 mg/kg bw ) in rats no indication of adverse effects on development was noted. This is supported in a read across approach data were considered from studies performed with the disodium salt of sebacic acid the C10 analog of dodecandioic acid with both rats and rabbits at dose levels of 500 and 1000 mg/kg bw/d, for rats and rabbits respectively.
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- The key study was the only study available and was a read across study from dodecanedioic acid (CAS 693-23-2). The key study was the only study available and was a read across study from dodecanedioic acid (CAS 693-23-2). The key study was given a reliability Klimisch score of 2. When assessed the overall quality of the database is high. This decreases the uncertainty in the prediction of the NOAEL for tridecanedioic acid (CAS No. 505-52-2).
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
No adverse effects on fertility were noted in a combined repeat dose reproductive toxicity test.
Also no adverse effects were noted on reproductive organs in other repeated dose studies.
There is no reproductive toxicity data available for tridecanedioic acid (CAS No. 505-52-2) A read-across approach was conducted with data from a Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test from dodecanedioic acid (CAS 693-23-2).
Short description of key information:
Read across from dodecanedioic acid (CAS 693-23-2) - Combined Repeated Dose Toxicity Study with Reproduction/Developmental Toxicity Screening Test, NOAEL (parent): 1000 mg/kg bw/day; OECD 422, GLP)
.
Justification for selection of Effect on fertility via oral route:
Only 1 key study available.
Effects on developmental toxicity
Description of key information
Reproductive/developmental screening test (oral administration of 50; 100; 1000 mg/kg bw ) was performed in rats. No indication of adverse effects on development.
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- The key study was the only study available and was a read across study from dodecanedioic acid (CAS 693-23-2). The key study was the only study available and was a read across study from dodecanedioic acid (CAS 693-23-2). The key study was given a reliability Klimisch score of 2. When assessed the overall quality of the database is high. This decreases the uncertainty in the prediction of the NOAEL for tridecanedioic acid (CAS No. 505-52-2).
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Additional information
No developmental toxicity as observed in a screening test in rats at dose levels of up to 1000 mg/kg bw/day (4.3 mmol/kg bw/day) dodecanedioic acid.
Justification for selection of Effect on developmental toxicity: via oral route:
Only 1 key study available.
Toxicity to reproduction: other studies
Additional information
No developmental toxicity was observed in a screening test in rats at dose levels of up to 1000 mg/kg bw/day (4.3 mmol/kg bw/day) dodecanedioic acid. This observation is supported by read-across to developmental toxicity studies with the disodium salts of C10 -homologue dicarboxylic acid, decanedioic acid (sebacic acid), at dose levels of 500 mg/kg bw/day (2.0 mmol/kg bw/day corresponding to 460.6 mg/kg bw/day dodecanedioic acid) in rats and 1000 mg/kg bw/day (4.06 mmol/kg bw/day corresponding to 935 mg/kg bw/day dodecanedioic acid) in rabbits where also a lack of developmental toxicity was demonstrated.
The complete read across justification is attached as document.
Justification for classification or non-classification
No adverse effects were noted on fertility or development, therefore no classification regarding reproductive toxicity is required.
Additional information
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.
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