Registration Dossier
Registration Dossier
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 205-016-3 | CAS number: 131-17-9
- 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 (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Between 17 December 2002 and 06 January 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline Study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Diallyl phthalate
- EC Number:
- 205-016-3
- EC Name:
- Diallyl phthalate
- Cas Number:
- 131-17-9
- Molecular formula:
- C14H14O4
- IUPAC Name:
- 1,2-bis(prop-2-en-1-yl) benzene-1,2-dicarboxylate
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): Diallyl Phthalate
- Physical state: clear colorless liquid
- Lot/batch No.: 12092
- Storage conditions: approximately 4°C in the dark
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/Ca
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: B & K Universal Ltd, Hull, UK.
- Age at study initiation: eight to twelve weeks old
- Weight at study initiation: 15 to 23g
- Housing: solid-floor polypropylene cages furnished with softwood woodflakes.
- Free access to mains tap water and food (Certified Rat and Mouse Diet (Code 5LF2) supplied by International Product Supplies Limited, Wellingborough, Northants, UK) was allowed throughout the study.
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25
- Humidity (%): 30 to 70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): twelve hours continuous light (06.00 ta 18.00) and twelve hours darkness.
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 0.5, 5, or 50 % w/v
- No. of animals per dose:
- 2 mice for preleminary test
4 mice per dose in the main test - Details on study design:
- RANGE FINDING TESTS:
In order to establish that dose levels chosen for use in the main study were non-toxic a range-finder test was performed using two mice. Each mouse was treated by daily application of 25µl of the undiluted test material or a concentration of 50% w/v in acetone/olive oil 4:1, to the dorsal surface of each ear for up to three consecutive days (Days 0, 1, 2). The animals were observed daily for up to 5 days. Any signs of toxicity or signs of ill health during this period were recorded. The bodyweight of each mouse was recorded on Day 0 (prior to dosing) and the surviving mouse on Day 5. The highest concentration producing no signs of systemic toxicity or skin irritation plus two lower concentrations were chosen for the main study.
- Compound solubility: acetone/olive oil 4:1 vehicle was chosen as it produced the most suitable formulation at the required concentration.
- Irritation / Lymph node proliferation response: The highest concentration producing no signs of systemic toxicity or skin irritation plus two lower concentrations were chosen for the main study.
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Criteria used to consider a positive response: The test substance will be regarded as a sensitiser if at least one concentration of the test material results in a threefold or greater increase in 3HTdR incorporation compared to control values. Any test material failing to produce a threefold or greater increase in 3HTdR incorporation, will be classified as a "non-sensitiser".
TREATMENT PREPARATION AND ADMINISTRATION:
Groups of four mice were treated with the test material at concentrations of 0.5%, 5% or 50% w/v in acetone/olive ail 4:1. Results from the range-finder test indicated that the test material would not produce systemic toxicity or excessive local irritation at the maximum concentration of 50% w/v.
The mice were treated by daily application of 25 µl of the appropriate concentration of the test material to the dorsal surface of each ear for three consecutive days (Days 0, 1, 2). The test material formulation was adrninistered using an automatic micropipette and spread over the dorsal surface of the ear using the tip of the pipette. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- The Stimulation Index (SI) expressed as the mean radioactive incorporation for each treatment group divided by the mean radioactive incorporation of the vehicle control group are as folIows: 5.7, 5.5, and 33.5, respctively for 5, 10, and 50% w/v in Acetone/Olive Oil 4:1.
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- 0.98
- Test group / Remarks:
- 0.5%
- Key result
- Parameter:
- SI
- Value:
- 3.23
- Test group / Remarks:
- 5%
- Key result
- Parameter:
- SI
- Value:
- 10.74
- Test group / Remarks:
- 50%
Any other information on results incl. tables
Dpm, Dpm/Node and Stimulation Index (SI)
Concentration (% w/v) in acetone/olive oil 4:1 | Dpm | Dpm/Node | Stimulation Index (SI) | Result |
Vehicle | 9005.91 | 1125.74 | N/A | N/A |
0.5 | 8838.93 | 1104.87 | 0.98 | Negative |
5 | 29087.39 | 3635.92 | 3.23 | Positive |
50 | 96725.08 | 12090.64 | 10.74 | Positive |
Dpm/Node obtained by dividing the Dpm value by 8 (total number of lymph nodes)
Stimulation Index of 3.0 or greater indicates a positive result.
N/A = Not Applicable
The latest positive control was α-Hexylcinnamaldehyde. Five positive substances have previously been investigated.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: other: The test material was classified as a sensitiser according to EU labelling regulations Commission Directive 2001/59/EC.
- Conclusions:
- The test material was considered to be a sensitiser under the conditions of the test.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
