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Diss Factsheets
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EC number: 500-099-5 | CAS number: 37625-56-2
- 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://chesar.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 16 to 19 September 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Proprietary GLP and guideline-compliant study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- CAPA 3050
- IUPAC Name:
- CAPA 3050
- Reference substance name:
- ε-Caprolactone, oligomeric reaction products with propylidynetrimethanol
- EC Number:
- 500-099-5
- EC Name:
- ε-Caprolactone, oligomeric reaction products with propylidynetrimethanol
- Cas Number:
- 37625-56-2
- Molecular formula:
- (C6H14O3)x.C6H10O2 (x=0-6)
- IUPAC Name:
- 2-Oxepanone, polymer with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol
- Reference substance name:
- 2-Oxepanone, polymer with 2-ethyl-2-(hydroxymethyl)-1, 3-propanediol
- IUPAC Name:
- 2-Oxepanone, polymer with 2-ethyl-2-(hydroxymethyl)-1, 3-propanediol
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): CAPA 3050
- Substance type: Oligomer
- Physical state: Liquid
- Analytical purity: 100%
- Lot/batch No.: WCB000999
- Expiration date of the lot/batch: 23th August 2015
- Stability under test conditions: Stable for the duration of the study
- Storage condition of test material: Ambient
Constituent 1
Constituent 2
Constituent 3
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- The animals were male SPF-derived New Zealand White rabbits (2.5-3.0 kg), obtained from Harlan Olac, Zeist, The Netherlands. The animals were acclimatised for 11 days, and inspected be a veterinarian at the beginning of the the acclimatisation period. No abnormalties were detected.The rabbits were individually housed in stainless steel wire cages (KK 102). Bedding material was not provided. The rabbits received 80 g standard kaboratory diet (LKK-20, Hope Farms, The Netherlands), per day during the acclimatisation period. During the experiment the rabbits had free access to food and water. The animal room was maintained at a temperature of 19-20°C, relative humidity of 55-72%, artifical light was provided for 12 hours oer day, and radio-sound was provided for 24 hours per day. There were approximately 16 air changes per hour.
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 g
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 30-60 minutes after patch removal, then 24, 48 and 72 hours later.
- Number of animals:
- Three male rabbits.
- Details on study design:
- On the last day of acclimatisation, the backs of the rabbits were clipped free of hair. Three different test materials were tested on each rabbit at the same time (CAPA 205, CAPA 304, CAPA 305). Three separate 6 cm² patches were prepared per animal, 1 per substance. The patches, containing 0.5 g of test substance per patch, were held under occlusive Blenderm tape and secured in place on the back of the animal by adhesive tape. The animals were fitted with Elizabethan collars (IMS, Cheshire, UK) for the duration of the exposure period. After the 4 hour exposure period, the collars and patches were removed and the skin was wiped to remove and remaining test substance.Skin reactions were scored according to erythema and eschar formation (graded 0-4), and oedema formation (graded 0-4).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: All time points
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects observed
- Remarks on result:
- other: No effects at any time point
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: all time points
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects observed
- Remarks on result:
- other: No effects at any time point
- Irritant / corrosive response data:
- A single dermal exposure to CAPA 305 for 4 hours caused no erythema or oedema at any time point.
- Other effects:
- No other effects were reported.
Any other information on results incl. tables
No rabbit was given a score above zero at any of the time points up to 72 hours after patch removal, for either erythema or oedema formation.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated informationCriteria used for interpretation of results: EU
- Conclusions:
- CAPA 305 was considered to cause no skin irritation in rabbits. CAPA 305 was therefore classified as not irritating under CLP.
- Executive summary:
The primary irritation potential of CAPA 305 was determined according to OECD method 404. A sample of 0.5 g of CAPA 305 was applied to the shaved intact back skin of 3 male New Zealand White rabbits, and held under an occlusive patch for 4 hours. Readings of the reactions for erythema and oedema were made at 30 minutes, and 24, 48 and 72 hours after patch removal. No signs of irritation were observed at any time point. CAPA 305 was therefore considered to cause no skin irritation in rabbits.
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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