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EC number: 248-368-3 | CAS number: 27253-26-5
- 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:
- 1993-03-14 to 1993-04-22
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Testing performed following Good Laboratory Guidelines (GLP).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- Buehler test
Test material
- Reference substance name:
- Diisotridecyl phthalate
- EC Number:
- 248-368-3
- EC Name:
- Diisotridecyl phthalate
- Cas Number:
- 27253-26-5
- Molecular formula:
- C34H58O4
- IUPAC Name:
- 1,2-bis(2-methyldodecyl) benzene-1,2-dicarboxylate
- Details on test material:
- - Name of test material (as cited in study report): VESTINOL TD
- Substance type: pure active substance
- Physical state: liquid
- Analytical purity: 99.6 % (v/v)
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components: Diisotridecyl phthalate
- Purity test date: no data
- Lot/batch No.: not known
- Expiration date of the lot/batch: September 1993 at the earliest
- Stability under test conditions: not mentioned
- Storage condition of test material: in a closed container under hood
- Other: Date of production: 1992-09-21
Stability: > 1 year
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Dunkin Hartley, Pirbright White
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Winkelman, Borchen, Germany
- Age at study initiation: young adults, no further details mentioned
- Weight at study initiation: test group: 473 ± 22 g; control group: 469 ± 35 g (mean weights)
- Housing: conventional, Makrolon Type IV cages (maximum 5 animals per cage)
- Diet: Ssniff G4 complete feed for guinea pigs ad libitum, supplied by Ssniff Spezialfutter GmbH, Soest, Germany
- Water: drinking water ad libitum, supplied by Gelsenwasser, Wasserwerk, Haltern, Germany
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: not mentioned (preliminary study)
not mentioned (main study)
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- induction: 100%
challenge: 100%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- induction: 100%
challenge: 100%
- No. of animals per dose:
- test animals: 19 (main experiment), 4 (pilot study)
control animals: 10 - Details on study design:
- RANGE FINDING TESTS:
Determination of the non-irritant concentration of the test substance with occlusive epicutaneous applications for 6 hours of
test substance 40%, 60% and 80% in corn oil MEH 56 and 100% (undiluted). Readings directly after patch removal and 24
and 48 hours post application.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: occlusive dermal applications for 6 hours, scoring at 6 and 24 hours after application
- Test group: receiving test substance (0.4 cm³/patch)
- Control group: receiving vehicle (0.4 cm³ corn oil/patch)
- Site: left flanks
- Frequency of applications: induction on days 0, 7 and 14
- Duration: 3 weeks
- Concentrations: 100% (undiluted) test substance
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: on day 28
- Exposure period: occlusive dermal application for 6 hours
- Test groups: receiving test substance (0.4 cm³/patch)
- Control group: receiving test substance (0.4 cm³/patch)
- Site: right flanks
- Concentrations: 100 % (undiluted)
- Evaluation (hr after challenge): 6, 24, 48 and 72 hours post application - Challenge controls:
- same treatment as test group animals
- Positive control substance(s):
- yes
- Remarks:
- 1-chloro-2,4-dinitrobenzene
Results and discussion
- Positive control results:
- The responsivness of the used strain was tested at regular intervalls, no further details mentioned.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- other: all time points (24, 48 and 72 hours p.a.)
- Group:
- test chemical
- Dose level:
- undiluted test substance
- No. with + reactions:
- 0
- Total no. in group:
- 19
- Clinical observations:
- No test substance related systemic effects or impairment of body weight gain were observed.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: other: all time points (24, 48 and 72 hours p.a.). Group: test group. Dose level: undiluted test substance. No with. + reactions: 0.0. Total no. in groups: 19.0. Clinical observations: No test substance related systemic effects or impairment of body weight gain were observed..
- Reading:
- other: all time points (24, 48 and 72 hours p.a.)
- Group:
- negative control
- Dose level:
- undiluted test substance
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: other: all time points (24, 48 and 72 hours p.a.). Group: negative control. Dose level: undiluted test substance. No with. + reactions: 0.0. Total no. in groups: 10.0.
Any other information on results incl. tables
RESULTS OF PILOT STUDY: No irritant effects at any concentration of the test substance tested.
RESULTS OF TEST.
- Sensitisation reaction: No sensitising effects observed.
- Clinical signs: No clinical effects observed. Body weight increase comparable to control.
- Rechallenge: not performed
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- The test material did not product evidence of skin sensitisation (delayed contact hypersensitivity) in any of the 19 test animals.
- Executive summary:
In this study, 19 guinea pigs were exposed to DTDP in a skin sensitization exposure paradigm utilizing and induction and challenge phase in the method of the Buehler test. A patch was saturated with approximately 0.4 ml of test material was placed on the skin. Contact with the skin was maintained for approximately 6 hours. The dressings were then removed and the resulting dermal reactions assessed approximately 24 hours later. Inductions were conducted on days 0, 7, and 14. The challenge application was given topically 28days after the induction via the same method and scored for dermal reactions 6, 24, 48 and 72 hours post exposure. In all cases, DTDP did not produce any dermal reactions.
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