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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

Toxicity to reproduction
Administrative data
- Endpoint:
- extended one-generation reproductive toxicity - basic test design (Cohorts 1A, and 1B without extension)
- Type of information:
- experimental study planned
- Study period:
- To be confirmed following approval of the testing proposal by ECHA
- Justification for type of information:
- TESTING PROPOSAL ON VERTEBRATE ANIMALS
NON-CONFIDENTIAL NAME OF SUBSTANCE:
CAPA 3050
CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
- Available GLP studies: No adequate and reliable GLP studies addressing reproductive toxicity are available with the test substance or similar substance. A sub-chronic repeated dose oral toxicity study in the rat conducted according to OECD test guideline 408 has been proposed. If this study shows classifcation would be required for reproductive toxicity, then further testing to address this endpoint would not be necessary. A stepwise testing approach is therefore proposed.
- Available non-GLP studies: No adequate and reliable non-GLP studies addressing reproductive toxicity are available with the test substance or similar substance
- Historical human data: No data are available
- (Q)SAR: Currently available Q(SAR) methods are not applicable to assess the full scope of reproductive toxicity.
- In vitro methods: No validated in vitro methods to asess reproductive toxicity are available to date.
- Weight of evidence: There are no data to assess the reproductive toxicity of the test substance; a weight of evidence approach is therefore not appropriate.
- Grouping and read-across: There are no similar subtances which are considered to be acceptable for read-across; a read-across proposal was made previously, but this was rejected by ECHA.
CONSIDERATIONS THAT THE SPECIFIC ADAPTATION POSSIBILITIES OF ANNEXES VI TO X (AND COLUMN 2 THEREOF) OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
- The generation of data to addess the toxicity to reproduction is a standard requirement under REACH at this tonnage band and cannot be adapted for this substance based on any Ccolumn 2 or Annex XI adaptions.
FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- A study is proposed to be conducted with CAPA 3050 according to OECD test guideline 443 (basic design) in the rat via the oral route. The study will include cohorts 1A and 1B, without extension.
Data source
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 443 (Extended One-Generation Reproductive Toxicity Study)
- Justification for study design:
- SPECIFICATION OF STUDY DESIGN FOR EXTENDED ONE-GENERATION REPRODUCTION TOXICITY STUDY WITH JUSTIFICATIONS
- Premating exposure duration for parental (P0) animals: 10 weeks, to cover a complete cycle of spermatogenesis
- Basis for dose level selection: to be confirmed, based on the results of the proposed 90-day study
- Inclusion/exclusion of extension of Cohort 1B: exclusion. The standard requirement is not to include the extension of Cohort 1B; however this will be confirmed based on the presence of any findings of concern (triggers) in the proposed 90-day study
- Termination time for F2: not relevant
- Inclusion/exclusion of developmental neurotoxicity Cohorts 2A and 2B: exclusion. The standard requirement is not to include the extension of Cohorts 2A and 2B; however this will be confirmed based on the presence of any findings of concern (triggers) in the proposed 90-day study
- Inclusion/exclusion of developmental immunotoxicity Cohort 3: exclusion. The standard requirement is not to include the extension of Cohort 3; however this will be confirmed based on the presence of any findings of concern (triggers) in the proposed 90-day study
- Route of administration: oral (dietary)
- Other considerations, e.g. on choice of species, strain, vehicle and number of animals: not applicable.
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:
- rat
Results and discussion
Applicant's summary and conclusion
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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