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Diss Factsheets
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EC number: 939-396-3 | 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
Short-term toxicity to fish
Administrative data
Link to relevant study record(s)
- Endpoint:
- short-term toxicity to fish
- Type of information:
- calculation (if not (Q)SAR)
- Remarks:
- estimated by calculation
- Adequacy of study:
- key study
- Study period:
- 2014-05-26 to 2014-05-28
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- results derived from a valid (Q)SAR model and falling into its applicability domain, with adequate and reliable documentation / justification
- 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 203 (Fish, Acute Toxicity Test)
- Deviations:
- yes
- Remarks:
- Calculation method
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method C.1 (Acute Toxicity for Fish)
- Deviations:
- yes
- Remarks:
- Calculation method
- Principles of method if other than guideline:
- The acute toxicity to fish was determined using a calculation method for the Mode of Action in question. This algorithm is based on a QSAR model which has been validated to be compliant with the OECD recommendations for QSAR modeling (OECD, 2004). Further to this the lethal loading rate of the WAF is determined by using a series of calculation steps using phase equilibrium thermodynamics and excluding the non-bioavailable fraction, this approach is based on validated data derived from 96-hour LL50 tests on fish, for which the concentrations of the test item had been determined by chemical analyses over the test period.
- GLP compliance:
- no
- Specific details on test material used for the study:
- Not applicable
- Analytical monitoring:
- no
- Details on sampling:
- Not applicable
- Vehicle:
- no
- Details on test solutions:
- Not applicable
- Test organisms (species):
- Danio rerio (previous name: Brachydanio rerio)
- Details on test organisms:
- No data
- Test type:
- other: calculation method
- Water media type:
- not specified
- Total exposure duration:
- 96 h
- Post exposure observation period:
- Not applicable
- Hardness:
- Hardness is not a necessary component of the WAF calculation
- Test temperature:
- The Temperature is not a necessary component of the WAF calculation but extremely low or high temperatures could influence the solubility of certain constituents. Therefore, the calculation method is considered acceptable to determine LL50s for fish between 12 and 28 °C.
- pH:
- The pH is not a necessary component of the WAF calculation
- Dissolved oxygen:
- The oxygen concentration is not a necessary component of the WAF calculation
- Salinity:
- Salinity is not a necessary component of the WAF calculation. However as the fish QSAR for the constituents calculation was based on data from freshwater studies, the resulting calculation is considered valid for freshwater fish
- Nominal and measured concentrations:
- The calculation determines measured concentrations
- Details on test conditions:
- Calculation method
- Reference substance (positive control):
- not required
- Key result
- Duration:
- 96 h
- Dose descriptor:
- LL50
- Effect conc.:
- 52 mg/L
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Details on results:
- Not applicable
- Results with reference substance (positive control):
- Not applicable
- Reported statistics and error estimates:
- Not applicable
- Sublethal observations / clinical signs:
Table 6.1.1/1: Expected concentrations at this 96 h-LL50
Constituents
concentration in the WAF (mg/L)
cis-p-menthan-8-ol
17.89
trans-p-menthan-8-ol
15.29
cis-p-menthan-1-ol
10.92
trans-p-menthan-1-ol
6.45
- Validity criteria fulfilled:
- yes
- Conclusions:
- 96 h-LL50 for Dihydroterpineol multiconstituent is 52 mg/L.
Based on the results of this study, dihydroterpineol multiconstituent would not be classified as acute 1 to aquatic organisms in accordance with the CLP regulation. - Executive summary:
The acute toxicity of dihydroterpineol multiconstituent to fish has been investigated using an in-house calculation method that replaces an OECD 203 study and guideline for Testing of Chemicals No. 23 (i.e. WAF conditions).
The first step of the iSafeRat mixture toxicity calculation employs phase equilibrium thermodynamics in order to determine the concentrations of each constituent within the WAF. This fraction equates to the analysable fraction of a WAF study. In the calculation the second step is to remove this non-bioavailable fraction. Within the WAF, the constituents also partition between themselves further reducing the bioavailable fraction and thus the toxicity of the mixture compared to the individual constituents.
The final step is to determine the truly bioavailable fraction of the WAF per constituent. The LC50s of each constituent were predicted using the iSafeRat QSAR model. Each value has been included in the record and QPRF as well as the QMRF has been attached in the iuclid. An additivity approach (based on Chemical Activity of each constituent) is used in order to calculate the Effective Loading rate of the WAF.
The 96-h LL50 of dihydroterpineol multiconstituent was 52 mg test material/L.
Based on the results of this study, dihydroterpineol multiconstituent would not be classified as acute 1 to aquatic organisms in accordance with the CLP regulation.
This toxicity study is acceptable and can be used for that endpoint.
Results Synopsis
Test Type: Calculation method
LL50: 52 mg test item/L
Reference
Description of key information
The 96 h-LL50 to Danio rerio for dihydroterpineol multiconstituent was determined by a calculation method: 52 mg/L.
Key value for chemical safety assessment
Fresh water fish
Fresh water fish
- Effect concentration:
- 52 mg/L
Additional information
A calculation method prediction was available and allowed to assess the lethal loading rate, LL50 (Median Lethal Loading) of test item dihydroterpineol multiconstituent, a multiconstituent substance, to fish within a period of 96h using the WAF method.
This calculation method predicts the endpoint value which would be expected when testing the substance under experimental conditions in a laboratory following OECD Guideline 203 and EU method C.1 adapted for testing as a mixture using the WAF method.
The LC50s of each constituent are already known from literature or predicted using the iSafeRat QSAR model. An additivity approach (based on Chemical Activity of each constituent) is used in order to calculate the Lethal Loading of the WAF. Using this approach, the 96-h LL50 for dihydroterpineol multiconstituent to fish is 52 mg/L.This toxicity study is acceptable and can be used for that 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.
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