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Diss Factsheets
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EC number: 203-225-4 | CAS number: 104-67-6
- 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
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Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 22 July - 05 August 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- GLP study conducted according to OECD Guideline 402 with minor deviations: no certificate of analysis of the test substance
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- no certificate of analysis of the test substance
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Undecan-4-olide
- EC Number:
- 203-225-4
- EC Name:
- Undecan-4-olide
- Cas Number:
- 104-67-6
- Molecular formula:
- C11H20O2
- IUPAC Name:
- 5-heptyloxolan-2-one
- Test material form:
- liquid: viscous
- Details on test material:
- - Name of test material (as cited in study report): 2(3H)-Furanone, 5-heptyldihydro; ALDEHYD C14 SOG; HR 99/606009 (Test no. 1999224)
- Physical state: Colourless slightly viscous liquid
- Analytical purity: 98.3 %
- Specific gravity: 0.935
- Date received: 21 June 1999
- Batch No.: 9020026
- Storage condition of test material: Approximately 4 °C in the dark
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK) Ltd, Kent, UK
- Age at study initiation: 8-12 weeks
- Weight at study initiation: Males: 222-233 g; females: 211-226 g
- Housing: Animals were housed in suspended polypropylene cages furnished with woodflakes. Animals were housed individually during the 24 h exposure period and in groups of 5/sex for the remainder of the study.
- Diet: Rat and Mouse Expanded Diet No. 1 (Special Diets Services Limited, Essex, UK), ad libitum
- Water: Mains drinking water, ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 19-25 °C
- Humidity: 30-70 %
- Air changes: Approximately 15/h
- Photoperiod: 12 h darkness / 12 h continuous light
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: Test material was applied on the shorn skin of back and flank region.
- % coverage: Approximately 10 % of the total body surface area
- Type of wrap if used: A piece of surgical gauze was placed over the treatment area and semi-occluded with a piece of self-adhesive bandage.
REMOVAL OF TEST SUBSTANCE
- Washing: After 24 h contact period, the bandage was carefully removed and the treated skin and surrounding hair wiped with cotton wool moistened with distilled water to remove any residual test material.
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.14 mL/kg bw
- Constant volume or concentration used: Yes - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: Animals were observed for deaths or overt signs of toxicity at 0.5, 1, 2 and 4 h after dosing and subsequently once daily for 14 days.
- Frequency of weighing: Individual body weights were recorded prior to application of the test material on Day 0 and on Days 7 and 14.
- Necropsy of survivors performed: Yes, all the animals were killed by cervical dislocation at the termination of study and subjected to gross pathological examination.
- Other examinations performed: After removal of the dressings and subsequently once daily for 14 days, the test sites were examined for evidence of primary irritation and scored according to the method of Draize (1977). - Statistics:
- None
Results and discussion
- Preliminary study:
- None
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed.
- Clinical signs:
- other: No signs of systemic toxicity or skin irritation were noted.
- Gross pathology:
- No abnormalities were noted at necropsy.
- Other findings:
- None
Any other information on results incl. tables
None
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute dermal LD50 of γ-Undecalactone, is higher than 2000 mg/kg bw in rats therefore it is not classified according to the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.
- Executive summary:
In an acute dermal toxicity study (limit test) performed according to OECD Guideline 402 and in compliance with GLP, a groups of 10 rats (5/sex) of Sprague-Dawley CD (Crl:CD (SD) IGS BR) strain was administered a single dermal dose of γ-Undecalactone, at 2000 mg/kg bw on clipped skin using a semi-occlusive patch for 24 h. Animals were then observed for mortality, clinical signs, bodyweights and dermal reactions for 14 days and were all macroscopically necropsied after sacrifice.
No deaths occurred throughout the study. No signs of systemic toxicity or skin irritation were noted. Animals showed an expected gain in body weight during the study. No abnormalities were noted at necropsy. In this study, the acute dermal LD50 of γ-Undecalactone, was considered to be higher than 2000 mg/kg bw in rats.
Under the test conditions, the combined acute dermal LD50 of γ-Undecalactone, is higher than 2000 mg/kg bw in rats therefore it is not classified according to the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.
This study is considered as acceptable and satisfies the requirement for acute dermal toxicity endpoint.
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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