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: 205-524-5 | CAS number: 142-16-5
- 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:
- 1994-03-11 to 1994-04-22
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Cross-reference
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Remarks:
- Statement included
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- Th LLNA was not available at the time where the study was conducted.
Test material
- Reference substance name:
- Bis(2-ethylhexyl) maleate
- EC Number:
- 205-524-5
- EC Name:
- Bis(2-ethylhexyl) maleate
- Cas Number:
- 142-16-5
- Molecular formula:
- C20H36O4
- IUPAC Name:
- bis(2-ethylhexyl) but-2-enedioate
- Reference substance name:
- Dioctyl maleate
- EC Number:
- 220-835-6
- EC Name:
- Dioctyl maleate
- Cas Number:
- 2915-53-9
- Molecular formula:
- C20H36O4
- IUPAC Name:
- dioctyl but-2-enedioate
- Details on test material:
- - Name of test material (as cited in study report): Dioctylmaleinat
- Chemical name: (Z)-2-Butendisäure-bis-(2ethyl)ester
- Substance type: active substance
- Physical state: colorless - yellow liquid
- Analytical purity: 96.1%
- Lot/batch No.: Ch 35559, Beh. 828
- Expiration date of the lot/batch: August 1994
- Storage condition of test material: in closed vessels in the flue
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Versuchstierzucht, Borchen, Germany
- Age at study initiation: young adults
- Weight at study initiation: less than 500g
- Housing: conventional housing in Makrolon type IV cages with a maximum of 5 animals per cage
- Diet: Ssniff G 4-Alleindiät for guinea pigs ad libitum
- Water: tap water ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 30 - 70%
- Air changes: 15fold air changes per hour
- Photoperiod: 12-hours dark/12 hours light
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- 2.5, 25, 50 and 100% (w/w)
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- 2.5, 25, 50 and 100% (w/w)
- No. of animals per dose:
- Five animals per test concentration, ten animal in the control group
- Details on study design:
- RANGE FINDING TESTS:
Three animal were shaved and the test item was applied at four different test concentrations with a gauze bandage on the shaved skim. The bandage were fixated by means of an occlusive patch for an exposure period of 6 hours. At the end of the exposure period, the patches were removed and the animals were monitored for skin reactions for a duration of 30 and 54 hours. No skin irritation could be observed.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 hours
- Test groups: 1 (3 animals)
- Control group: none
- Site: left flank
- Frequency of applications: day 0, day 7, and day 14
- Concentrations: 2.5, 25, 50 and 100% (w/w). Pure corn oil was applied in the control.
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: Day 28
- Exposure period: 6 hours
- Test groups: 1 (20 animals)
- Control group: 1 (10 animals)
- Site: right flank
- Concentration: 25% (w/w)
- Evaluation (hr after challenge): 30 and 54 hour after application - Challenge controls:
- A 25% test solution was also applied in the control group.
- Positive control substance(s):
- yes
- Remarks:
- 2-Mercaptobenzothiazol (2-MCBT)
Results and discussion
- Positive control results:
- The application of 2-Mercaptobenzothiazol resulted in strong sensiting effects at all test animals
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 30
- Group:
- test chemical
- Dose level:
- 100% test item
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Clinical observations:
- none
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 54
- Group:
- test chemical
- Dose level:
- 100% test item
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Clinical observations:
- none
- Reading:
- 1st reading
- Hours after challenge:
- 30
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Clinical observations:
- none
- Reading:
- 2nd reading
- Hours after challenge:
- 54
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Clinical observations:
- none
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 50% 2-MCBT
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- none
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- positive control
- Dose level:
- 50% 2-MCBT
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- none
Any other information on results incl. tables
No sensitizing effects were observed
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- As no effects could be observed, it can be concluded that dioctyl maleate is not a sensitizer in the Bühler-test.
- Executive summary:
In a dermal sensitization study with dioctyl maleate dissolved in corn oil, 20 young adult female Dunkin-Hartley guinea pigs were tested using the method of Bühler. No sensitizing or irritating effects of the skin were observed during the test period. In this study, dioctyl maleate is not a dermal sensitizer.
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.

EU Privacy Disclaimer
This website uses cookies to ensure you get the best experience on our websites.