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EC number: 251-718-8 | CAS number: 33885-52-8
- 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:
- 23 July 1980 to 6 August 1980
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Justification for type of information:
- Used for read across to Pinyl Isobutyraldehyde
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
Reference
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Information is derived from read across
- Justification for type of information:
- The read across justification is presented in the acute toxicity endpoint summary and the accompanying files are also attached there.
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Interpretation of results:
- other: Not acute toxic
- Remarks:
- in accordance with EU CLP (EC 1272/2008 and its updates)
- Conclusions:
- Based on the results of the study for read-across substance Floralozone, Pinyl Isobutyraldehyde (PIBA) is considered to be not acute toxic via the oral route.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Reaction mass of Benzenepropanal, 4-ethyl-α,α-dimethyl- and 3-(2-ethylphenyl)-2,2-dimethylpropanal
- EC Number:
- 916-329-6
- Molecular formula:
- C13H18O
- IUPAC Name:
- Reaction mass of Benzenepropanal, 4-ethyl-α,α-dimethyl- and 3-(2-ethylphenyl)-2,2-dimethylpropanal
- Test material form:
- liquid
- Details on test material:
- As described in 1.2 of dossier
1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Ace Animals
- Age at study initiation: 8 weeks
- Weight at study initiation: 221 – 250 g
- Fasting period before study: 16 – 20 hours
- Housing: animals were housed 5 per cage in suspended wire mesh cages
- Diet: fresh Purina rat chow, ad libitum
- Water: ad libitum
- Acclimation period: at least one week
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 10
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: animals were observed 3-4 hours after dosing and once daily for 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs
Results and discussion
Effect levels
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: Cas no of Floralozone is 67634-15-5
- Mortality:
- 4 out of 10 animals exposed to 5000 mg/kg bw died.
- Clinical signs:
- other: Lethargy was noted in 5 animals on day 1. Oily anogenital area was noted in 5 or more animals on day 1 and 2. The survivors were normal until day 11 and 12 when piloerection was noted in several animals. Ptosis was noted in 1 animal on day 13. The survivi
- Gross pathology:
- - No effects were observed in the animals that were sacrificed on day 14.
- Stained brown anogenital area, congested lung, dilated heart, excess fluid in pleural cavity, stomach and intestines distended, intestines grey and/or purple and pale exudate contained in pleural cavities and pericardium were observed in animals that died.
Applicant's summary and conclusion
- Interpretation of results:
- other: Not acute toxic
- Remarks:
- in accordance with EU CLP (EC 1272/2008 and its updates)
- Conclusions:
- The acute oral toxicity test showed a LD50 of > 5000 mg/kg bw. Based on this result, the substance is considered to be not acute toxic via the oral route.
- Executive summary:
Floralozone is tested for acute oral toxicity in a study performed similar to OECD TG 401. Ten male Wistar rats were exposed to the test substance via oral gavage. Animals received a dose of 5000 mg/kg bw. After an observation period of 14 days animals were necropsied. In this study 2 animals died at day 2, one at day 6 and one at day 12. Lethargy and oily anogenital area was noted in 5 or more animals. The survivors were normal until day 11 and 12 when piloerection was noted in several animals. Ptosis was noted in 1 animal on day 13. The surviving animals were normal on day 14. No effects were observed upon necropsy in the animals that were sacrificed on day 14. In the animals that died the following effects were seen: stained brown anogenital area, congested lung, dilated heart, excess fluid in pleural cavity, stomach and intestines distended, intestines grey and/or purple and pale exudate contained in pleural cavities and pericardium.The LD50 was determined to be higher than 5000 mg/kg bw.
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