Registration Dossier
Registration Dossier
Diss Factsheets
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EC number: 203-090-1 | CAS number: 103-23-1
- 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

Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
in vitro
Ames negative (similar to OECD 471, CMA 1982)
Ames: negative (similar to OECD 471, Zeiger, 1985)
Mouse Lymphoma: negative (similar to OECD 476, McGregor 1988)
Mouse Lymphoma: negative (similar to OECD 476, CMA 1982)
CA: negative with S9, ambiguous without S9 (Galloway 1987)
SCE: negative without S9, ambiguous with S9 (similar to OECD 479,
Galloway 1987)
in vivo
MNT, i.p.: negative (similar to OECD 474, Shelby 1993)
MNT, i.p.: negative (similar to OECD 474, CMA 1982)
Dominant lethal assay: negative (similar to OECD 478, Singh 1975)
Additional information
No mutations were found when Diethylhexyl adipate (DEHA) was incubated with TA-98, -100, -1535, - 1537, or -1538 Salmonella strains with and without metabolic activation at concentrations up to 150µl/plate, which corresponds to 139000µg/plate (CMA 1982; Zeiger et al. 1985). In addition, there was no evidence of mammalian cell mutation in mouse lymphoma assays conducted with and without metabolic activation (McGregor et al. 1998; CMA unpublished studies, 1982) up to 5000µg/mL. Cytotoxicity was observed in both assays and precipitation occured at and above 1000µg/mL. In a chromosome aberration assay an ambiguous result was obtained without S9, while in an SCE assay treatment in the presence of S9 led to ambiguous results (Galloway 1987). Since no clear positive result was obtained, the results are contradictory (ambiguous results only in the presence or absence of S9), and no hint for chromosome aberration was observed in two mouse lymphoma and several in vivo studies, DEHA is believed not to cause chromosome aberration in mammalian cells. Additionally, no unscheduled DNA synthesis was oberserved in primary rat hepatocytes (CMA, 1982, cited in OECD SIDS 2000).
Two independent mouse micronucleus assays were conducted without evidence of interaction with DNA even at a dose level of 5000 mg/kg (CMA , 1982 ; Shelby et al ., 1993). In a dominant-lethal study using mice, DEHA did not demonstrate decreases in litter size that might suggest adverse effects on spermatogenesis up to doses of close to 10000mg/kg (Singh et al ., 1975).
Justification for classification or non-classification
Based on the available data, classification as a genotoxic substance is not triggered according to EU Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
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