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Diss Factsheets
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EC number: 249-079-5 | CAS number: 28553-12-0
- 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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Respiratory sensitisation
Administrative data
- Endpoint:
- respiratory sensitisation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well-documented study.
Data source
Reference
- Reference Type:
- publication
- Title:
- Phthalate treatment does not influence levels of IgE or Th2 cytokines in B6C3F1 mice
- Author:
- Butala JH, David RM, Gans G, McKee RH, Guo TL, Peachee VL, White KL Jr.
- Year:
- 2 004
- Bibliographic source:
- Toxicology. 2004 Sep 1;201(1-3):77-85.
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Topical application (and challenge) of test substances to mice followed by measurements of total serum IgE. In addition, auricular lymph nodes were harvested for measurement of IL-4 and IL-13 proteins and their corresponding messenger RNAs. Because skin absorption of high molecular weight phthalates is limited, liver weight increase, a measure of peroxisomal proliferation, was monitored to assure that internal dosing had been achieved.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 1,2-Benzenedicarboxylic acid, di-C8-10-branched alkyl esters, C9-rich
- EC Number:
- 271-090-9
- EC Name:
- 1,2-Benzenedicarboxylic acid, di-C8-10-branched alkyl esters, C9-rich
- Cas Number:
- 68515-48-0
- Molecular formula:
- C26 H42 O4
- IUPAC Name:
- 1,2-Benzenedicarboxylic acid, di-C8-10-branched alkyl esters, C9-rich
- Reference substance name:
- DINP
- IUPAC Name:
- DINP
Constituent 1
Constituent 2
Test animals
- Species:
- mouse
- Strain:
- B6C3F1
- Sex:
- not specified
Test system
- Route of induction exposure:
- dermal
- Route of challenge exposure:
- other: application to ear
- Vehicle:
- unchanged (no vehicle)
- Concentration:
- undiluted, 50 ul/flank
- No. of animals per dose:
- 10
- Positive control substance(s):
- trimellitic anhydride (TMA)
- Negative control substance(s):
- 2,4-dinitrochlorobenzene (DNCB)
Results and discussion
- Results:
- The mice tolerated the treatment well; all animals survived, and there were no significant differences in body weight. Liver weights of DINP- treated mice were significantly elevated with respect to control at the P < 0.05 level. Total serum IgE levels were significantly increased by treatment with the positive control, TMA. There were also smaller but still significant increases in IgE levels in mice treated with DNCB. The appropriate responses with the reference compounds demonstrated the specificity of the assay system. In contrast to these materials, total IgE levels in serum from mice treated with the DINP were not significantly different from control values. The assessment of IL-4 and IL-13 levels in cultured lymph node cells revealed a large and statistically significant increase in cells from mice treated with TMA. IL-4 and IL-13 levels were also elevated in the DNCB-treated groups in some situations, but were not significantly different from control values. Neither IL-4 nor IL-13 was elevated in cells from control group mice or mice treated with DINP. Similarly, TMA significantly increased IL-4 and IL-13 mRNA levels in lymph node cells. DNCB treatment increased IL-4 and IL-13 mRNA in some cases, but these differences, while sometimes statistically significant, were well below levels associated with TMA treatment. DINP treatment had no effect on IL-4 or IL-13 mRNA levels.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Executive summary:
Bronchial asthma is mediated, in part, by the immunoregulatory cytokines interleukins 4 and 13 (IL-4 and IL-13). These cytokines stimulate IgE synthesis that in turn is associated with airway hyper-responsiveness. Compounds that stimulate IgE synthesis and elicit bronchial reactivity are generally considered to be respiratory sensitizers. To address this question, topical application (and challenge) of test substances (DINP included) to mice followed by measurements of total serum IgE was performed. In addition, auricular lymph nodes were harvested for measurement of IL-4 and IL-13 proteins and their corresponding messenger RNAs. Because skin absorption of high molecular weight phthalates is limited, liver weight increase, a measure of peroxisomal proliferation, was monitored to assure that internal dosing had been achieved. ELISA and RNAse protection assays demonstrated that DINP treatment did not significantly affect IgE, IL-4, or IL-13 levels. Similarly, IL-4 and IL-13 mRNA levels were not elevated. In contrast, all of these were significantly elevated by trimellitic anhydride (TMA), a respiratory sensitizer used as the positive control in this assay. Another control, dinitrochlorobenzene (DNCB), a contact sensitizer, also responded as expected, producing smaller but statistically significant increases in IgE and in mRNA for IL-4 and IL-13 but not in the levels of these cytokines. In summary, treatment with DINP did not result in significant elevations indicating that DINP has little, if any, potential to produce anti-body-mediated respiratory allergy.
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