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EC number: 916-331-7 | CAS number: -
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 8 December 1976 - 4 March 1977
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The test was performed pre-GLP and similar to OECD guideline 401. However, the materials, methods and results are reported clearly.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 977
- Report date:
- 1977
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- two animals tested in lowest and highest dose group
- GLP compliance:
- no
- Remarks:
- pre-GLP
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Reaction mass of 3a,4,5,6,7,7a-hexahydro-4,7-methano-1H-inden-5-yl isobutyrate and 3a,4,5,6,7,7a-hexahydro-4,7-methano-1H-inden-6-yl isobutyrate
- EC Number:
- 916-331-7
- Molecular formula:
- C14H20O2
- IUPAC Name:
- Reaction mass of 3a,4,5,6,7,7a-hexahydro-4,7-methano-1H-inden-5-yl isobutyrate and 3a,4,5,6,7,7a-hexahydro-4,7-methano-1H-inden-6-yl isobutyrate
- Test material form:
- liquid
1
Test animals
- Species:
- mouse
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 4-5 weeks
- Fasting period before study: 4 hours
- Housing: individual cages
- Diet: commercial pelleted diet ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
-No data
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED:
-10.0 ml/kg bw
RATIONALE FOR THE SELECTION OF THE STARTING DOSE:
-A range-finding test is performed for each test material to determine an approximate order of toxicity using 5 male en 5 female animals. In this test, which is used for suspected low toxic materials, the most relevant dose-level for the class of substance is selected. Three male and three female animals are dosed at this level, and one male en one female dosed both above and below this level. - Doses:
- -10.0 ml/kg bw
-5.0 ml/kg bw
-2.0 ml/kg bw - No. of animals per sex per dose:
- -10.0 ml/kg bw 1 male and one female
-5.0 ml/kg bw 3 males and 3 females
-2.0 ml/kg bw 1 male and one female - Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 7 days
- Necropsy of survivors performed: yes - Statistics:
- no data
Results and discussion
- Preliminary study:
- Not relevant
Effect levelsopen allclose all
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 10 mL/kg bw
- Based on:
- test mat.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 9 733 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed.
- Clinical signs:
- other: The mice dosed at 5.0 ml/kg and 10.0 ml/kg were hypothermic and showing signs of stress within 30 mins. after treatment. After 18 hours all mice except for the male mouse dosed at 10.0 ml/kg had recovered, and this animal recovered within 42 hours. The mi
- Gross pathology:
- At autopsy pale intestines, and mottled liver, kidneys and spleens were observed.
Applicant's summary and conclusion
- Interpretation of results:
- other: not acute orally toxic
- Remarks:
- according to EU CLP (EC1272/2008 and its amendments)
- Conclusions:
- No mortality was observed, resulting in an approximate acute LD50 value of >10.0 ml/kg bw corresponding to >9733 mg/kg. It can be concluded that Cyclabute was not acute toxic via the oral route under the conditions of this test.
- Executive summary:
An acute oral range-finding toxicity test was performed with oral intubation in 4 -5 week old white mice. Three doses were tested: 2.0 ml/kg (1 male/ 1 female) 5.0 ml/kg (3 male/ 3 female) and 10.0 ml/kg (1 male/ 1 female), corresponding to 1945, 4867, and 9733 mg/kg bw.Animals were observed for 7 days after intubation.
The mice dosed at 5.0 ml/kg and 10.0 ml/kg were hypothermic and showing signs of stress within 30 minutes after treatment. After 18 hours all mice except for the male mouse dosed at 10.0 ml/kg had recovered, and this animal recovered within 42 hours. The mice dosed at 2.0 ml/kg appeared unaffected by the treatment. All mice gained weight during the 7 day observation period. No animals died during observation period. All survivors were killed and examined post mortem after 1 week, at autopsy pale intestines, mottled livers, kidneys and spleens were observed. An approximate acute LD50 value of >10.0 ml/kg bw corresponding to >9733 mg/kg, was identified. Based on these results, Cyclabute does not need to be classified as acute toxic via the oral route in accordance with the criteria outlined in Annex VI of 67/548/EEC and Annex I of 1272/2008/EC, under the conditions of these test.
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