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Diss Factsheets
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EC number: 943-338-2 | 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
Endpoint summary
Administrative data
Description of key information
The oral LD50 of Reaction mass of 3,6-dihydro-4-methyl-2-phenyl-2H-pyran and tetrahydro-4-methylene-2-phenyl-2H-pyran, is higher than 2000 mg/kg bw in rats therefore it is not classified according to the Directive 67/548/EEC and the CLP Regulation. No acute inhalation or dermal studies were available.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1980
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non-GLP study conducted similarly to OECD Guideline 401 with deviations: no data about purity and no certificate of analysis of test substance; bodyweight changes were not reported
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- no GLP statement; no data about purity and no certificate of analysis of test substance; bodyweight changes were not reported
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- other: Cpb; WU; Wistar Random
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: Young adult
- Source: Central Institute for the Breading of Laboratory Animals TNO, Zeist, The Netherlands
- Weight at study initiation: Males: 160-205 g; females: 114-162 g
- Housing: Animals were housed in groups of five in screen-bottomed stainless steel cages.
- Fasting period before study: Overnight
- Diet: Stock diet, ad libitum
- Water: Tap water, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature: 23 ± 1 °C
- Ventilation: Well-ventilated room - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME ADMINISTERED: 6 mL/kg bw
- Doses:
- 3.5, 4.2, 5.0 and 6.0 mL/kg bw
- No. of animals per sex per dose:
- Five
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Necropsy of survivors performed: Yes - Statistics:
- LD50 value was calculated according to the method of Weil (1952).
- Preliminary study:
- Not applicable
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 4.2 mL/kg bw
- Based on:
- test mat.
- 95% CL:
- 3.27 - 5.37
- Remarks on result:
- other: equivalent to 4229 (3293-5408) mg/kg bw; calculated using the density of 1.007 g/L (literature)
- Mortality:
- Number of dead animals:
- At 3.5 mL/kg bw: 1/5 male and 2/5 females
- At 4.2 mL/kg bw: 2/5 males and 3/5 females
- At 5.0 mL/kg bw: 3/5 males and 4/5 females
- At 6.0 mL/kg bw: 3/5 males and 4/5 females
- Deaths occurred between 5 hours and 3 days after dosing. - Clinical signs:
- other: - Sluggishness, sedation and ataxia were observed within a few hours after treatment and later, coma was frequently observed. - All survivors recovered gradually and appeared healthy at the end of the observation period.
- Gross pathology:
- - Gross observations at necropsy were normal for all of the surviving animals.
- Other findings:
- None
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The oral LD50 of Reaction mass of 3,6-dihydro-4-methyl-2-phenyl-2H-pyran and tetrahydro-4-methylene-2-phenyl-2H-pyran, is higher than 2000 mg/kg bw in rats therefore it is not classified according to the Directive 67/548/EEC and the CLP Regulation.
- Executive summary:
In an acute oral toxicity study performed similarly to OECD Guideline 401, groups of rats (5/sex/group) were given a single oral dose of Reaction mass of 3,6-dihydro-4-methyl-2-phenyl-2H-pyran and tetrahydro-4-methylene-2-phenyl-2H-pyran at 3.5, 4.2, 5.0 and 6.0 mL/kg bw. Animals were then observed for mortality and clinical signs for 14 days and all survivors were macroscopically necropsied after sacrifice.
Mortalities were 30, 50, 70 and 70 % at 3.5, 4.2, 5.0 and 6.0 mL/kg bw, respectively. Deaths occurred between 5 hours and 3 days after dosing. Sluggishness, sedation and ataxia were observed within a few hours after treatment and later, coma was frequently observed. All survivors recovered gradually, appeared healthy at the end of the observation period and presented a normal appearance at autopsy. In this study, the combined oral LD50 of Reaction mass of 3,6-dihydro-4-methyl-2-phenyl-2H-pyran and tetrahydro-4-methylene-2-phenyl-2H-pyran in rats was calculated to be 4.2 (3.27-5.37) mL/kg bw [equivalent to 4229 (3293-5408) mg/kg bw; calculated using the density of 1.007 g/L (literature)].
The oral LD50 of Reaction mass of 3,6-dihydro-4-methyl-2-phenyl-2H-pyran and tetrahydro-4-methylene-2-phenyl-2H-pyran is higher than 2000 mg/kg bw in rats therefore it is not classified according to the Directive 67/548/EEC and the CLP Regulation.
Reference
None
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 4 229 mg/kg bw
- Quality of whole database:
- Acceptable
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Reliable in vivo study
Justification for classification or non-classification
Based on the results of reliable tests in laboratory animals, classification under the EU DSD or CLP regulations as acutely toxic by the oral routes is not required.
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.
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