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Diss Factsheets
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EC number: 203-438-2 | CAS number: 106-88-7
- 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
![](https://echa.europa.eu./o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
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:
- test procedure in accordance with national standard methods with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Principles of method if other than guideline:
- The guinea pig sensitization method used was a modification of the method of Maguire (1973): The Bioassay of Contact Allergens in the Guinea pig. J. Soc. Cosmetic Chem. 24, 151-162.
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The test was performed before the OECD guideline 429 (LLNA) entered into force.
Test material
- Reference substance name:
- 1,2-epoxybutane
- EC Number:
- 203-438-2
- EC Name:
- 1,2-epoxybutane
- Cas Number:
- 106-88-7
- Molecular formula:
- C4H8O
- IUPAC Name:
- oxolane
- Test material form:
- liquid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratories, Inc., Kingston, New York
- Age at study initiation: no data
- Weight at study initiation: no data
- Housing: housed 5 per cage
- Diet: ad libitum, commercial certified laboratory chow (Ralston Purina Company, St. Louis, Missouri)
- Water: ad libitum, tap water
- Acclimation period: at least one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0.1 mL undiluted test material
- Day(s)/duration:
- 14 days
- Adequacy of induction:
- not specified
Challenge
- Route:
- epicutaneous, open
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0.1 mL undiluted test material
- Day(s)/duration:
- 48 hours
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 10/dose
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 4
- Exposure period: 7 days
- Test groups: 0.1 mL
- Control group: not included
- Site: back
The guinea pig sensitization method used was a modification of the method of Maguire (1973). The test material was applied undiluted. Ten guinea pigs received 4 applications of the test material within 7 days during the insult phase of testing. An additional group of 10 guinea pigs received DER* 331 epoxy resin as a 10% solution in DOWANOL DPM/ Tween 80 ( 9:1). The epoxy resin is known to be a skin sensitizer and served as a positive control. Each insult application consisted of 0.1 mL of the test material or the positive control resin applied to a gauze square patch, placed on the back of the guinea pig, then secured and covered with adhesive tape. The first insult application was allowed to remain in place for 48 hours, then removed, and a second application of 0.1 mL was made. At the time of the third application, a total of 0.2 mL of Freund's Adjuvant, (Bacto-Adjuvant complete, H37RA DIFCO Laboratories, Detroit, Michigan) was injected intradermally adjacent to the insult site. Forty-eight hours after this application, the patch was removed and a fresh patch of 0.1 mL of the material was applied. The last patch was removed 48 hours later and the animals allowed to rest for two weeks. Each time the insult patches were removed, observations for primary irritation effects were made and recorded.
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge:
- Exposure period: 48 hours
- Test groups: 0.1 mL
- Control group: not included
- Site: flanks
- Evaluation (hr after challenge): 24 and 48
After a two-week rest period, both flanks of the animal were clipped and challenged with the test solution on one side and if diluted, the appropriate solvent on the other. The challenge applications were not covered. Skin response at these sites was recorded at 24 and 48 hours after application. - Positive control substance(s):
- yes
- Remarks:
- DER 331 epoxy resin
Results and discussion
- Positive control results:
- A positive response indicative of sensitization (slight to moderate redness) was observed on 9 of 10 guinea pigs receiving DER 331.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.1 mL
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.1 mL
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 10%
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 1st reading
- Group:
- negative control
- Remarks on result:
- not measured/tested
Any other information on results incl. tables
None of the 10 guinea pigs treated with the undiluted test material revealed signs of sensitization. Therefore, this material was not considered a potential human skin sensitizer.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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.
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