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EC number: 201-557-4 | CAS number: 84-74-2
- 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
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 19 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- RL2
Additional information
A 90-day study performed according to current standards with repeated oral administration in rats revealed a NOAEL of 152 mg/kg bw. At 752 mg/kg bw, hematological and clinical chemical changes, increased liver and kidney weights and histopathological changes in the liver were
seen. However no testicular changes were seen in this study up to and including the highest dose-level of 752 mg/kg bw while in special studies in rats on these effects even the lowest doselevel of 250 mg/kg bw showed an effect (changes in testicular enzymes associated with degeneration of spermatogenic cells). No neurotoxicity was seen in this study.
In addition a NOAEL of 19.9 mg/kg bw in rats with respect to peroxisomal proliferation was found in a special study focused on this effect. However, humans have a low sensitivity for this phenomenon.
Studies with repeated dermal exposure were not appropriate for establishing a NOAEL or LOAEL.
For repeated inhalation exposure a NOAEC of 509 mg DBP/m3 (the highest concentration tested) for systemic effects including neurotoxic effects can be established based on a 28-day inhalation study in rats performed according to current standards. In this 28-day inhalation study in rats the
lowest exposure concentration of 1.18 mg/m3 is a LOAEC for local effects (histopathological changes in upper respiratory tract).
The epidemiological studies on neurological symptoms in occupationally exposed subjects showed several limitations including lack of an appropriate control group, small size of the exposed population, lack of adequate documentation of protocol and results and mixed exposure to other compounds than DBP. Therefore these studies are inadequate for the assessment of neurotoxic effects caused by DBP in man in the working environment. (1)
Most studies examining subchronic and chronic toxicity of DBP are performed in rodents and involve dosing via the oral route. There are no reliable studies that involve repeated dermal exposure to DBP. In an inhalation study (Gamer et al. 2000*) performed according to OECD Guidelines 412 and 407 (for clinical and neurofunctional examinations and pathology) with Wistar rats, no systemic effects (including neurotoxicity) were seen at up to and including the highest dose of 509 mg/m3. Dose-dependent changes were localised in the nasal cavity and were considered to be adaptive. The systemic NOAEC was established as 509 mg/m3. The LOAEC for local adaptive effects in upper respiratory tract was 1.18 mg/m3.
The major adverse effects of DBP in the repeated oral dosing studies are related to liver and testicular toxicity. Increased kidney weight is also reported in some studies for both sexes or only in females, but not consistently through all studies and generally without any related histopathological changes.
The lowest NOAEL of 19.9 mg/kg bw/d was identified in a subchronic, two-week dietary study in rats, based on the activation of enzymes associated with peroxisome proliferation (LAH-11 and LAH-12 (11- and 12- lauric acid hydroxylase, respectively) at 60.6 mg/kg bw/d. In this study PCoA activity was also increased at higher doses (Jansen et al. 1993*).
The mechanisms by which DBP and other peroxisome proliferators induce chronic hepatotoxicity in rodents are not considered relevant to humans(2)
(1)
European Union Risk Assessment Report dibutyl phthalate, Volume 29, pp. 15 -16 (2003)
Editors: B. G. Hansen, S.J. Munn, R. A/Ianou, F. Berthault, J. de Bruin, M. Luotamo, C. Musset, S. Pakalin, G. Pellegrini, S. Scheen S. Vegro.
Office for Official Publications of the European Communities, ISBN 92—894—1276—3
(2)
Priority Existing Chemical Assessment Report No. 36, Dibutyl phthalate, November 2013, ISBN 978-0-9874434-4-1, p.82
Australian Government, Department of Health
NATIONAL INDUSTRIAL CHEMICALS NOTIFICATION AND ASSESSMENT SCHEME
GPO Box 58, Sydney NSW 2001 AUSTRALIA www.nicnas.gov.au
Repeated dose toxicity: via oral route - systemic effects (target organ) digestive: liver
Justification for classification or non-classification
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.
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