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EC number: 201-553-2 | CAS number: 84-69-5
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1954
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- he study was conducted prior to institution of Good Laboratory Practices. The study was conducted by an internal Eastman Kodak Company method, developed prior to established guidelines, but was in accord with acceptable scientific standard methods in use at the time the study was conducted. The results of this study are valid for classification insofar as the conditions of exposure are at least as stringent as modern guidelines.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 954
- Report date:
- 1954
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- not specified
- Principles of method if other than guideline:
- Study conducted according to an intemal Eastman Kodak Company laboratory method, known as the drop-on method, not used elsewhere.
- GLP compliance:
- no
- Type of study:
- other: Guinea pig drop on method
Test material
- Reference substance name:
- Diisobutyl phthalate
- EC Number:
- 201-553-2
- EC Name:
- Diisobutyl phthalate
- Cas Number:
- 84-69-5
- Molecular formula:
- C16H22O4
- IUPAC Name:
- 1,2-bis(2-methylpropyl) benzene-1,2-dicarboxylate
- Details on test material:
- Source: TEC
Purity: no data
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- not specified
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, open
- Vehicle:
- other: All applications: 1:1:2 mixture of acetone:dioxane:corn oil
- Concentration / amount:
- 0.1M
Challengeopen allclose all
- Route:
- epicutaneous, open
- Vehicle:
- other: All applications: 1:1:2 mixture of acetone:dioxane:corn oil
- Concentration / amount:
- 0.1M
- No. of animals per dose:
- 5
- Details on study design:
- Two groups of five guinea pigs were used to determine the dermal sensitization potential of the test substance using the Kodak Drop-On Method. The irritant potential of a 0.1 M solution of the test substance in a 1:1:3 mixture of Acetone: Dioxane: Corn Oil was determined 24 and 48 hours following application to the clipped back skin of five animals. An additional group of animals was treated with only the solvent mixture. A third group of animals was treated with a 0.1 M solution of a positive control substance, phenylhydrazine, in a mixture of Dioxane and Corn Oil. Animals were repeatedly treated topically for a period of two weeks. The degree of the response (erythema and edema) seen after the last application was compared to the readings seen after the first application to estimate potential for dermal sensitization following repeated exposure to the test material.
- Positive control substance(s):
- yes
- Remarks:
- phenylhydrazine
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- No erythema or edema
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: No erythema or edema.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- No erythema or edema
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: No erythema or edema.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.1 M
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- No erythema or edema
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.1 M. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: No erythema or edema.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.1 M
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- No erythema or edema
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.1 M. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: No erythema or edema.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- Diisobutyl phthalate is not considered to be a skin sensitizer using the Kodak Drop-on Method. Based on an absence of positive effects in this study, this material is not classifiable for Skin Sensitization according to UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS) or EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
- Executive summary:
In a study with diisobutyl phthalate using the Kodak Drop-on Method, a group of five guinea pigs were treated with multiple topical applications of an 0.1 M solution of the test substance in acetone:dioxane:corn oil (1:1:2) over a two-week period. The final observations were compared to the initial observations to determine potential sensitization by the test material. A group of five control guinea pigs were treated with only the solvent mixture. Twenty four and forty-eight hours after the last application, the reactions in the control and test groups were similar. Based on the results of this study using the Kodak Drop-on Method, it was determined that diisobutyl phthalate was a not a dermal sensitizer.
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