Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
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: 265-499-1 | CAS number: 65138-66-1
- 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:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data is from handbook or collection of data
Data source
Referenceopen allclose all
- Reference Type:
- other: Authoritative database
- Title:
- determination of Skin sensitization for CAS no: 117-81-7
- Author:
- HSDB
- Year:
- 2 017
- Bibliographic source:
- U.S. National Library of Medicine National Institutes of Health, Health & Human Services
- Reference Type:
- secondary source
- Title:
- European Union Risk Assessment Report-bis(2-ethylhexyl)phthalate (DEHP)
- Author:
- European Chemicals Bureau
- Year:
- 2 008
- Bibliographic source:
- European Union Risk Assessment Report-bis(2-ethylhexyl)phthalate (DEHP); 2nd Priority List, Volume: 80; Final Report, 2008 Sweden.
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- Magnusson-Kligman guinea pig maximization test was performed for chemical Bis(2-ethylhexyl)phthalate (CAS no: 117-81-7) in female albino Dunkin-Hartley guinea pigs to assess its skin sensitization potential.
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- not specified
Test material
- Reference substance name:
- 1,2-Benzenedicarboxylic acid bis (2-ethylhexyl) ester
- Cas Number:
- 117-81-7
- Molecular formula:
- C24H38O4
- IUPAC Name:
- 1,2-Benzenedicarboxylic acid bis (2-ethylhexyl) ester
- Test material form:
- liquid
- Details on test material:
- Name of the test chemical: 1,2-Benzenedicarboxylic acid bis (2-ethylhexyl) ester
Common Name: bis(2-ethylhexyl)phthalate (DEHP)
Molecular Formula: C24H38O4
Molecular Weight: 390.5602 g/mol
InChI: 1S/C24H38O4/c1-5-9-13-19(7-3)17-27-23(25)21-15-11-12-16-22(21)24(26)28-18-20(8-4)14-10-6-2/h11-12,15-16,19-20H,5-10,13-14,17-18H2,1-4H3
Smiles:CCCCC(CC)COC(=O)c1ccccc1C(=O)OCC(CC)CCCC
Substance Type: Organic
Physical State: Liquid
Constituent 1
- Specific details on test material used for the study:
- Name of the test chemical: 1,2-Benzenedicarboxylic acid bis (2-ethylhexyl) ester
Common Name: bis(2-ethylhexyl)phthalate (DEHP)
Molecular Formula: C24H38O4
Molecular Weight: 390.5602 g/mol
InChI: 1S/C24H38O4/c1-5-9-13-19(7-3)17-27-23(25)21-15-11-12-16-22(21)24(26)28-18-20(8-4)14-10-6-2/h11-12,15-16,19-20H,5-10,13-14,17-18H2,1-4H3
Smiles:CCCCC(CC)COC(=O)c1ccccc1C(=O)OCC(CC)CCCC
Substance Type: Organic
Physical State: Liquid
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: albino Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- No data available
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- paraffin oil
- Concentration / amount:
- intradermal : 3 injections
• Freund’s adjuvant alone (0.1 ml)
• 10% DEHP in paraffin oil (0.1 ml)
• 10% DEHP in paraffin oil emulsified with 0.05 ml Freund’s adjuvant (0.05 ml).
epicutaneous: 50% DEHP in paraffin oil - Day(s)/duration:
- intradermal :7 days epicutaneous: 48 hours
- Adequacy of induction:
- not specified
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- 50% DEHP in paraffin oil
- Day(s)/duration:
- 24 hours
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- No data available
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE: Intradermal
- No. of exposures: 1
- Exposure period: 7 days
- Test groups: no data
- Control group: no data
- Site: the skin of the shoulder region
- Frequency of applications: no data
- Duration: 7 days
- Concentrations: 3 injections
• Freund’s adjuvant alone (0.1 ml)
• 10% DEHP in paraffin oil (0.1 ml)
• 10% DEHP in paraffin oil emulsified with 0.05 ml Freund’s adjuvant (0.05 ml).
A. II.INDUCTION EXPOSURE
- No. of exposures: 1
- Exposure period: 48 hours
- Test groups: no data
- Control group: no data
- Site: pre-treated area
- Frequency of applications: no data
- Duration: no data
- Concentrations: 50% DEHP in paraffin oil
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 14 days later
- Exposure period: 24 hours
- Test groups: no data
- Control group: no data
- Site: on the right flank
- Concentrations: 50% DEHP
- Evaluation (hr after challenge): 24 hours after removal of the challenge patch - Challenge controls:
- The control group received 2 injections of Freund’s adjuvant only.
- Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Results
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Clinical observations:
- No skin sensitization was observed in treated guinea pigs.
- Remarks on result:
- no indication of skin sensitisation
In vivo (LLNA)
- Cellular proliferation data / Observations:
- No skin sensitization was observed in treated guinea pigs.
Applicant's summary and conclusion
- Interpretation of results:
- other: Not sensitizing
- Conclusions:
- The chemical Bis(2-ethylhexyl)phthalate (CAS no: 117-81-7) can be considered as not skin sensitizing to the guinea pigs’ skin in Magnusson-Kligman guinea pig maximization test.
- Executive summary:
Magnusson-Kligman guinea pig maximization test was performed for chemicalBis(2-ethylhexyl)phthalate (CAS no: 117-81-7)in female albino Dunkin-Hartley guinea pigs to assess its skin sensitization potential.
The induction procedure consisted of an intradermal injection of the test material followed by a topical application 7 days later. The guinea pigs received intradermal injection (actually 3 injections) of 0.1 ml Freund’s adjuvant alone, 0.1 ml 10% DEHP in paraffin oil, and 0.05 ml 10% DEHP in paraffin oil emulsified with 0.05 ml Freund’s adjuvant into the skin of the shoulder region. The control group received 2 injections of Freund’s adjuvant only.
For the topical application, a 2.2 cm patch of filter paper was wetted with 50% DEHP in paraffin oil and applied for 48 hours to the pre-treated area. The control group was not subjected to topical application.
After rest period of 14 days, the animals were challenged topically at higher non irritating concentration of concentrations 50% DEHP. A 2.2 cm patch wetted with 50% DEHP was applied to a challenge site (on the right flank) of all animals for 24 hours. The degree of response was assessed 24 hours after removal of the challenge patch and rated. Any animal showing erythema at the challenge site was considered to have shown a positive response.
Since there were no positive responses, the chemical Bis(2-ethylhexyl)phthalate (CAS no: 117-81-7)can be considered as not skin sensitizing to the guinea pigs’ skin.
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.