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EC number: 204-211-0 | CAS number: 117-81-7
- 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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- lack of data on materials (purity), no positive control
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- old test (1981) LLNA methodology not available that times
Test material
- Reference substance name:
- Bis(2-ethylhexyl) phthalate
- EC Number:
- 204-211-0
- EC Name:
- Bis(2-ethylhexyl) phthalate
- Cas Number:
- 117-81-7
- Molecular formula:
- C24H38O4
- IUPAC Name:
- 1,2-bis(2-ethylhexyl) benzene-1,2-dicarboxylate
- Details on test material:
- DEHP
Name: Vestinol AH as supplied by the sponsor
Purity: not indicated
Physical state: clear colourless liquid
Storage: in its original container under ambient conditions
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Porcellus Animal Limited
- Age at study initiation: no data
- Weight at study initiation: 300-400g
- Housing: 5/cage
- Diet (e.g. ad libitum): ad libitum BP Nutrition FD1 Diet (a supplement of hay was given)
- Water (e.g. ad libitum): ad libitum water
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 (17-22.5)
- Humidity (%): 52 (38-64)
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- paraffin oil
- Concentration / amount:
- intradermal induction: 10%
cutaneous induction: 50%
challenge phase: 50%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- intradermal induction: 10%
cutaneous induction: 50%
challenge phase: 50%
- No. of animals per dose:
- total of 32 female guinea pigs (20 in the test group and 10 in the control group, 2 were used for the preliminary test)
- Details on study design:
- RANGE FINDING TESTS:
Before challenging the test animals a maximum non-irritant concentration of the test material was determined in preliminary experiments on 2 of the 12 guinea pigs, which were pre-treated with 2 injections of Freund's adjuvant at the injection phase.
The test material was applied in a series of concentrations in paraffin oil to the shaved flanks of the guinea pigs, under the same occlusive patch system used for the topical induction. It was tested in this way at concentrations of 50%, 20%, 10% and 5% (v/v).
There were no positive responses and a concentration of 50% was selected as the challenge concentration.
MAIN TEST
The induction procedure consisted of an intradermal injection of the test material into the skin of the shoulder region followed by a topical application 7 days later.
The intradermal injection (actually 3 injections) consisted 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.
The control group received 2 injections of Freund’s adjuvant only.
For the topical application, a 2x2 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.
The challenge procedure, which consisted of a topical application, was carried out 14 days after the completion of the induction period. In preliminary experiments, a solution of 50% DEHP was determined to be non-irritant; higher concentrations were not tested. A 2x2 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. - Challenge controls:
- No
- Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Any other information on results incl. tables
DEHP was unequivocally not sensitising in the guinea pig maximization test; there were no positive responses.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Executive summary:
One Magnusson-Kligman guinea pig maximization test has been performed, in which female albino Dunkin-Hartley guinea pigs were used. The maximisation test comprised two procedures. The induction procedure consisted of an intradermal injection of the test material into the skin of the shoulder region followed by a topical application 7 days later. The intradermal injection (actually 3 injections) consisted 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. 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. The challenge procedure which consisted of a topical application was carried out 14 days after the completion of the induction period. In preliminary experiments, a solution of 50% DEHP was determined to be non-irritant; higher concentrations were not tested. 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. DEHP was unequivocally not sensitising in the guinea pig maximization test; there were no positive responses.
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