Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 931-714-9 | CAS number: 35255-57-3
- 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:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2016-03-14 to 2016-03-18
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: (7) Series on Testing and Assessment, No. 126, Short Guidance on the Threshold Approach for Acute Fish Toxicity
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.1 (Acute Toxicity for Fish)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- yes
- Details on sampling:
- The limit concentration and the control were analytically verified the test item via LC-MS/MS from freshly prepared media at the start and the end of the exposure.
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
An appropriate volume of the test item was pipetted directly into aquaria filled with an appropriate volume of the dilution water. The test media was mixed with an ultraturrax (1 min, 17000 rpm). - Test organisms (species):
- Danio rerio (previous name: Brachydanio rerio)
- Details on test organisms:
- - Supplier: Umweltbundesamt, Schichauweg 58, D-12307 Berlinj
- holding at the test facility at 23 ± 2°C and diffuse light (0.1 - 10 µmol photons · m-2 · s-1, natural photoperiod). The water was changed at least once per week.
- at least 12 days of acclimatisation and mortality < 5 % within these days before the start of exposure
- Feeding: food was provided 3 times per week (Sera Vipan; SERA GMBH). The amount of food was 4 % of the fish body weight per feeding day. The test fish were not be fed 24 h before the test start.
- Water: Tap water of local origin. The water was filtered on activated charcoal and aerated for at least 24 hours to remove chlorine.
Nominal water parameters: Hardness: 10 - 250 mg CaCO3/L; pH-value: 6.0 - 8.5 - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 96 h
- Test temperature:
- 23 ± 2°C
- Dissolved oxygen:
- not less than 60% of air saturation
- Nominal and measured concentrations:
- Nominal: 26 mg/L, tested as a threshold concentration
- Details on test conditions:
- - Preparation of the test medium: an appropriate volume of the test item was pipetted directly into aquaria filled with an appropriate volume of the dilution water. The test media was mixed with an ultraturrax (1 min, 17000 rpm).
- Control: 7 fish in dilution water (without test item) were tested under the same test conditions as the test replicates.
- Application: one application at the start of the study was performed.
- Test vessel : Glass aquaria of 13 L, filled with approximately 10 L (dimensions: 25.5/18/28 cm) , covered with glass plates.
- Test volume: about 10 L per vessel
- Aeration: gentle aeration
_ Dilution water: same as used for holding
- Number of fish: 7 zebrafish were used for each test concentration and the control (14 zebrafish for the whole study).
- Loading: fish density = 0.132 g fish per litre test solution.
- Average body length at the test end: 2.54 cm
- Average body weight at the test end: 0.189 g
- Replicates: one replicate per test concentration and control
- Introduction of fish: fish were introduced randomly to individual replicates.
- Feeding of test fish: the fish were not fed during the test.
- Light intensity: 0.1 – 10 µmol photons · m-2 · s-1 (corresponding to approximately 7 – 750 Lux)
- Photoperiod daily 12 hours photoperiod, which corresponded to the natural daylight hours, was maintained throughout exposure.
EFFECT PARAMETERS MEASURED (with observation intervals if applicable):
- Observation intervalls: after 2, 24, 48, 72 and 96 h.
- Criteria of effects: fish were considered dead if there was no visible movement (e.g. gill covers movement) and if touching of the caudal peduncle produced no reaction. Records were kept of visible abnormalities (e.g. loss of equilibrium, swimming behaviour, respiratory function, pigmentation, etc.).
- Measurement of fish size ofcontrol fish at the end of exposure. - Reference substance (positive control):
- no
- Key result
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 26 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Results with reference substance (positive control):
- No reference substance
- Sublethal observations / clinical signs:
Measured Exposure Concentrations during the Definitive Test
The measured concentration of the test item at the start of the exposure (0 hours) was 28.8 mg/L. At the end of the exposure (96 hours), the measured concentration of the test item was 28.8 mg/L.
Table6: Measured Concentrations and Percentage of the nominal Concentration of the Test Item
Sampling date
2016-03-14 (0 hours)
2016-03-18 (96 hours)
Date of Analysis
2016-03-14
2016-03-18
2,2,4‑(or 2,4,4)‑Trimethylhexane‑1,6‑diol
Nominal
test item concentration
[mg/L]
Measured
conc.
[mg/L]
[%]
Measured
conc.
[mg/L]
[%]
26.0
28.8
111
28.8
111
Control
< LOQ
< LOQ
Measured conc.= Measured concentration of the test item, dilution factor taken into account
% = Percentage of nominal concentration of the test item
LOQ = Limit of quantification (60.0 µg/L test item)
- Validity criteria fulfilled:
- yes
- Conclusions:
- In this study, the test substance was found to have no effect on the vitality of zebrafish after 96 hours at a nominal test item concentration of 26.0 mg/L.
In conclusion, the LC0 corresponds to the nominal test item concentration ≥ 26.0 mg/L. The LC50 and the LC100 correspond to the nominal test item concentration > 26.0 mg/L. - Executive summary:
The acute toxicity of the test substance to fish (zebrafish) was determined according to the principles of the OECD-Guideline for Testing of Chemicals No. 203 (1992) and EU Council Regulation (EC) No. 440/2008/ Method C.1 (2008) from 2016-03-14 to 2016-03-18 at the test facility.
An acute toxicity test under static conditions with the nominal threshold concentration of 26 mg/L was carried out. The selection of the test concentration was based on the derivation of a threshold concentration (TC) from the results of a daphnia toxicity test (ErC50 (0-48 h)=80 mg/L (provided by the sponsor) and an algae acute toxicity test (EyC50 (0 – 72 h)= 26.1 mg/L. The duration of the test was 96 hours. Seven test organisms were exposed to each test concentration and the control. The water quality parameters (temperature, pH-value and oxygen saturation) measured at 0, 24, 48, 72 and 96 hours were determined to be within the acceptable limits.
The determination of the test concentrations was carried out via LC-MS/MS. Evaluation was done from freshly prepared media after 0 h and from the corresponding aged test media after 96 h.
The measured concentration of the test substance in freshly prepared media at test start was 111% of the nominal value. The measured concentration at the end of exposure in the corresponding aged test media was 111% of the nominal value. Therefore, all effect values were based on nominal test item concentrations. The LC50 and the LC100 correspond to the nominal test item concentration > 26.0 mg/L.
Reference
Description of key information
The acute toxicity of the test substance to fish (zebrafish) was determined according to the principles of the OECD-Guideline for Testing of Chemicals No. 203 (1992) and EU Council Regulation (EC) No. 440/2008/ Method C.1 (2008) from 2016-03-14 to 2016-03-18 at the test facility.
An acute toxicity test under static conditions with the nominal threshold concentration of 26 mg/L was carried out. The selection of the test concentration was based on the derivation of a threshold concentration (TC) from the results of a daphnia toxicity test (EC50 (0-48 h)=80 mg/L (provided by the sponsor) and an algae acute toxicity test (EYC50 (0 – 72 h)= 26.1 mg/L. The duration of the test was 96 hours. Seven test organisms were exposed to each test concentration and the control.
The test substance was found to have no effect on the vitality of zebrafish after 96 hours at a nominal test item concentration of 26.0 mg/L.
In conclusion, the LC0 corresponds to the nominal test item concentration ≥ 26.0 mg/L. The LC50 and the LC100 correspond to the nominal test item concentration > 26.0 mg/L.
Key value for chemical safety assessment
Fresh water fish
Fresh water fish
- Effect concentration:
- 26 mg/L
Additional information
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.