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EC number: 219-376-4 | CAS number: 2426-08-6
- 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:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
Data source
Reference
- Reference Type:
- publication
- Title:
- Allergenicity of epoxy-reactive diluents in the guinea pig.
- Author:
- Thorgeirsson A., Fregert S., Magnusson B.
- Year:
- 1 975
- Bibliographic source:
- Berufsdermatosen. 1975 Oct;23(5):178-83. cited in US Environmental Protection Agency TSCATS: OTS0523514 Doc. I.D.: 40-7840108
Materials and methods
- Principles of method if other than guideline:
- The skin sensitising potential of the test substance was evaluated in the guinea pig maximisation test.
- GLP compliance:
- no
- Remarks:
- Study pre-dates GLP regulation
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- When this study was performed, the LLNA method was not yet well known or validated for skins sensitisation testing.
Test material
- Reference substance name:
- Butyl 2,3-epoxypropyl ether
- EC Number:
- 219-376-4
- EC Name:
- Butyl 2,3-epoxypropyl ether
- Cas Number:
- 2426-08-6
- Molecular formula:
- C7H14O2
- IUPAC Name:
- 2-(butoxymethyl)oxirane
- Test material form:
- liquid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Albino, not further specified.
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 300 - 400 gram
- Housing: caged in pairs
- Diet: a pellet diet.
- Water: tap, ad libitum.
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- propylene glycol
- Concentration / amount:
- Three injections in a row: 0.1 mL Freund's complete adjuvant, 0.1 mL of 10% of Epoxide No. 8 or 0.1 mL of 10% of the test substance and 0.1 mL of a mixture of 10% of Epoxide No. 8 or 10% test substance and equal amount of Freund's adjuvant.
- Adequacy of induction:
- not specified
- Route:
- epicutaneous, occlusive
- Vehicle:
- propylene glycol
- Concentration / amount:
- A 2 X 4 cm patch saturated with Epoxide No. 8 or the test substance (10 % in vehicle)
- Day(s)/duration:
- 48 hours
- Adequacy of induction:
- not specified
Challenge
- No.:
- #1
- Route:
- epicutaneous, open
- Vehicle:
- propylene glycol
- Concentration / amount:
- 1 drop of 0.1% of Epoxide No. 8, the test substance, cresylglycidyl ether and epoxy resin (Ferroclere 900)
- Day(s)/duration:
- 24 hours
- Adequacy of challenge:
- other: non-irritant concentration
- No. of animals per dose:
- 12
- Details on study design:
- Twelve animals were exposed to Epoxide No. 8 and 12 to the test substance. Another twelve served as controls. They were injected with Freund`s complete adjuvant as were the animals in the experimental group. The intradermal and topical irritancy of Epoxide No. 8 and the test substance was investigated in a preliminary study. A 10 % concentration in propylene glycol was found to be a suitable concentration for induction. A 0.1 % concentration in propylene glycol owas found to be non-irritant in a 24 hour occluded patch test.
Intradermal injections:
The animals in the experimental groups were exposed to the reactive diluents in a two stage procedure. The first stage of induction was performed by intradermal injections in the shoulder region. The hair in a 4 by 6 cm area in the scapular region was clipped with an electric clipper. Three injections of the following mixtures were made on each side in a row.
- 0.1 mL Freund`s complete adjuvant blended with an equal amount of water.
- 0.1 mL 10% Epoxide No. 8 or 0.1 mL 10% test substance.
- 0.1 mL of a mixture containing 10% Epoxide No. 8 or 10% test substance in propylene glycol and an equal amount of Freund`s adjuvant.
Topical application:
One week after the injections the same 4 by 6 cm area was clipped and shaved, after which the 2nd phase of induction was performed by closed patch exposure to Epoxide No. 8 or the test substance over the shoulder region. A 2 by 2cm patch of Whatmann No.3 MM paper was saturated with the reactive diluent 10% in propylene glycol. The patch was placed on the shaved skin and covered by an overlapping, impermeable plastic adhesive tape. This in turn was firmly secured by an elastic adhesive bandage wound around the torso of the animal. The dressing was left in place for 48 hours.
Challenge:
Challenge, also of the control animals was performed 2 weeks after the topical exposure. All the animals were patch tested with a 0.1% concentration of Epoxide No. 8, the test substance, cresylglycidyl ether and epoxy resin (Ferroclere 900) in propylene glycol. Hair was removed from a 5 by 5 cm area of the flank by clipping and shaving. The test substance (one drop) was applied to cellulose test patches, 80 mm of Whatmann No.3 MM, which were sealed to the flank for 24 hours under overlapping, impermeable plastic adhesive tape secured by Elastoplast wound around the trunk. The challenge sites were evaluated 24 hours after removal of the patches. Evaluation was facilitated by shaving the hair with an electric razor 3 hours before hand. The examiner was unware of the reactive diluent with which a given animal had been treated. Only diffuse or intense redness and/or swelling was regarded as a positive reaction. - Challenge controls:
- yes, 12 animals tested simultaneously.
- Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: animals treated and challenged with the test substance
- Dose level:
- 0.1 %
- No. with + reactions:
- 6
- Total no. in group:
- 12
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: Animals treated with the test substance and challenged with Epoxide No.8
- Dose level:
- 0.1 %
- No. with + reactions:
- 12
- Total no. in group:
- 12
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: Animals exposed to the test substance and challenged with Cresylglycidyl ether.
- Dose level:
- 0.1 %
- No. with + reactions:
- 8
- Total no. in group:
- 12
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: Animals exposed to the test substance and challenged with Epoxy resin
- Dose level:
- 0.1 %
- No. with + reactions:
- 0
- Total no. in group:
- 12
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.1%
- No. with + reactions:
- 0
- Total no. in group:
- 12
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: Animals exposed to Epoxide No.8 and challenged with Epoxide No.8
- Dose level:
- 0.1 %
- No. with + reactions:
- 12
- Total no. in group:
- 12
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: Animals exposed to Epoxide No.8 and challenged with the test substance
- Dose level:
- 0.1 %
- No. with + reactions:
- 4
- Total no. in group:
- 12
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: Animals exposed to Epoxide No.8 and challenged with Cresylglycidyl ether
- Dose level:
- 0.1%
- No. with + reactions:
- 4
- Total no. in group:
- 12
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: Animals exposed to Epoxide No.8 and challenged with Epoxide resin
- Dose level:
- 0.1 %
- No. with + reactions:
- 9
- Total no. in group:
- 12
- Remarks on result:
- positive indication of skin sensitisation
Any other information on results incl. tables
All of the 12 animals exposed to Epoxide NO.8 became sensitised. Cross reactions to the test substance and cresylglycidyl ether occurred in 4 of the animals, and to the epoxy resin in 9.
Of the 12 animals exposed to the test substance 6 became positive. Cross-sensitivity to Epoxide No.8 was found in all of them and to cresylglycidyl ether in 8. None of the animals in this group reacted to the epoxy resin. Of the 12 control animals, none reacted to any of the 4 compounds.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Remarks:
- Based on ≥ 30% responding at > 1% intradermal induction dose
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