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Diss Factsheets
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EC number: 204-557-2 | CAS number: 122-60-1
- 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
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Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Not reported
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Although this study was not conducted in accordance with GLP, in accordance with REACH Annex XI, Section 1.1.2, the study was conducted under same scientific principles as OECD 406 Skin Sensitisation and adequate documentation of the study is provided. The study is therefore considered adequate for fulfilling this endpoint and for risk assessment purposes.
Data source
Reference
- Reference Type:
- publication
- Title:
- Sensitizing capacity and cross-reactivity of phenylglycidyl ether studies in the guinea-pig maximization test
- Author:
- Anne Ponten
- Year:
- 2 009
- Bibliographic source:
- Ponten, A., Zimerson, E. and Bruze, M. (2009) Sensitizing capacity and cross-reactivity of phenylglycidyl ether studied in the guinea-pig maximization test. Contact Dermatitis, 60: 79-84.
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- not applicable
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- 2,3-epoxypropyl phenyl ether
- EC Number:
- 204-557-2
- EC Name:
- 2,3-epoxypropyl phenyl ether
- Cas Number:
- 122-60-1
- Molecular formula:
- C9H10O2
- IUPAC Name:
- 2-(phenoxymethyl)oxirane
- Details on test material:
- Phenylglycidyl ether was purchased from Acros Organics, Geel, Belgium. The manufacturers specifications indicated a purity of 99 % which was confirmed by high-performance liquid chromatography.
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- Female albino guinea-pigs weighing 400 (+/- 20) g of the Dunkin-Hartley (M & B A/S, Ry, Denmark) were used.
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- propylene glycol
- Concentration / amount:
- Intradermal induction: 0.55 % (w/v) (0.037 mol/l)
Topical induction: 0.83 % (w/v) (0.055 mol/l)
Challenge I: 1.7 % (w/v) (0.11 mol/l)
Challenge II: 1.7 % (w/v) (0.11 mol/l)*
* - The animals induced with PGE were additionally challenged (left flank) with a lower concentration of PGE (0.83 % (w/v) (0.055 mol/l))
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- propylene glycol
- Concentration / amount:
- Intradermal induction: 0.55 % (w/v) (0.037 mol/l)
Topical induction: 0.83 % (w/v) (0.055 mol/l)
Challenge I: 1.7 % (w/v) (0.11 mol/l)
Challenge II: 1.7 % (w/v) (0.11 mol/l)*
* - The animals induced with PGE were additionally challenged (left flank) with a lower concentration of PGE (0.83 % (w/v) (0.055 mol/l))
- No. of animals per dose:
- 24 animals per test group were used in this study in addition to 12 control animals.
- Details on study design:
- Topical irritancy was determined by applying different concentrations of each substanceused for induction as a closed patch test for 2 days on both the neck and the flankof 4-6 animals. One week before testing, the animals were pre-treated with Freund's complete adjuvant (FCA) (Pierce, Rockford, IL, USA). Concentrations that did not cause irritation were chosen for topical induction and elicitation.
Induction Procedure
Day 0: three intradermal injections in a row at each side of the shoulder were given,
(i) 0.1 ml of FCA in water 40 % (w/v) (FCA/water 50:50 v/v);
(ii) 0.1 ml PGE dissolved in propylene glycol (0.55 % w/v);
(iii) 0.1 ml of a mixture of 40 % (w/v) FCA in propylene glycol including 0.55 % (w/v) PGE.
Day 6: pretreatment of a 2 x 4 cm area for topical induction with 0.2 ml sodium lauryl sulphate 10 % (w/v) in dimethylacetamide/acetone/ethanol 99.5 4:3:3 (v/v/v).
Day 7: topical induction with 0.2 ml of the induction substance in acetone on 2 x 4 cm piece of filter paper (130 g/m3; Munktell Filter AB, Grycksbo, Sweden) placed on Durapore (3M Health Care, St. Paul, MN, USA). The patches were covered with impermeable plastic adhesive tape (Acrylastic, Beiersdorf AG, Germany) and held in place with adhesice bandage (Durapore). The patches were left on for 2 days.
Controls: Twelve controls animals were given exactly the same treatment as described for the test animals, but with PGE excluded. In addition, six controls were given the known sensitiser 2-MP. These animals were used as a positive control.
Challenge I
Day 21: Sensitisation rate (right flank two patches), 12/24 test animals were challenged with the induction substance on both the cranial and caudal patch. 6 + 6 test animals were challenged with the induction substance on either the cranial patch or the caudal patch with vehicle alone on the other. A1-test (Imeco AB, Sodertalje, Sweden) on Durapore was used for patch testing. Thirty microlitres of the substance used for induction was applied. Acrylastic and an outer layer of Durapore held the challenge tests in place. The patches were removed after 1 day. Six of 12 control animals were tested with the induction substance on both patches, and 3 + 3 animals were patch tested with the induction substance on either the cranial or caudal patch, with vehicle alone on the other patch.
Challenge II
Animals were further challenged with induction substance as described above in addition to a challenge with a lower concentration of PGE (0.83 % (w/v)) on the left flank.
Evaluation
Day 23: the minimum criterion for a positive reaction is a confluent erythema. All tests were evaluated 1 day after the patches had been removed, i.e. 2 days after the application. First the right flanks (challenge I) were read and thereafter, the left flanks (challenge II) were read. - Positive control substance(s):
- yes
Study design: in vivo (LLNA)
- Positive control substance(s):
- other: 2-methylol phenol
- Statistics:
- The number of positive animals within the test group was compared with the number of of positive animals in the control group. The number of positive test animals was also compared with the number of positive animals tested with vehicle only. Among the animals challenged with the induction substance on both cranial and caudal patches (12 test animals and 6 control animals), only one of the patches chose in advance was included.
Statistical significance was calculated with one-sided Fisher's exact test. When a significant value (P < 0.05) was obtained both in comparison with the controls tested with allergen and the animals tested with vehicle alone, the compound (i.e. PGE) was judged as a sensitiser.
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 12
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. No with. + reactions: 0.0. Total no. in groups: 12.0.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1.7 % (w/v)
- No. with + reactions:
- 23
- Total no. in group:
- 24
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1.7 % (w/v). No with. + reactions: 23.0. Total no. in groups: 24.0.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.83 % (w/v)
- No. with + reactions:
- 24
- Total no. in group:
- 24
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.83 % (w/v). No with. + reactions: 24.0. Total no. in groups: 24.0.
Any other information on results incl. tables
PGE was found to be a strong sensitiser in the guinea-pig with 23/24 animals sensitised. No control animals had reactions to PGE (P < 0.001). Lowering the concentration for the challenge (left flank) did not reuduce the number of reacting animals. All 24 animals induced with PGE reacted when challenged with the lower concentration (left flank, P< 0.001).
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information
- Conclusions:
- Ph8enylglycidyl ether is a sensitiser in the guinea-pig maximisation 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.
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