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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 216-263-1 | CAS number: 1538-75-6
- 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 aquatic invertebrates
Administrative data
Link to relevant study record(s)
- Endpoint:
- short-term toxicity to aquatic invertebrates
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Read across from toxicity study to aquatic invertebrates of pivalic acid (CAS 75-98-9), which is the hydrolysis product of trimethylacetic anhydride, is possible. Trimethylacetic anhydride ist not stable in water and hydrolyses within hours (For details see chapter 5.1.2).
- Reason / purpose for cross-reference:
- read-across: supporting information
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Deviations:
- no
- GLP compliance:
- yes
- Specific details on test material used for the study:
- - Purity (GC): 99,9%
- Purity (neutralization titration): 99.7%
- pKa: 4.69 (estimated value)
- Freezing point: 35.0 °C - Analytical monitoring:
- yes
- Details on sampling:
- Sample collection frequency: Samples were taken from the new test solution at the start of exposure (0 time) and from the old test solution at the end of exposure (48 hours)
- Vehicle:
- no
- Details on test solutions:
- The purity was not corrected because the purity of the test substance was 99.9% (GC) and 99.7% (neutralization titration). A concentrated solution having a test substance concentration of 2,500 mg/L was prepared, and this concentrated solution was diluted with test water to prepare a test solution.
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- Origin:
- Source: National Institute for Environmental Studies, Japan
- Date of receipt: August 4, 1997
- Management after acquisition: subculture rearing (rearing period until generation update; 2 to 4 weeks, changing frequency; Twice a week)
- Results of sensitivity test: Reference substance Potassium dichromate; 48 h EC50 = 0.73 mg/L (95% confidence interval, 0.65-0.81 mg/L); (Within the regulations; Average value ± 30%: 0.51 to 0.96 mg / L, N = 7 (Testing period: from March 2007)]
- Exposure period September 28, 2010 - September 30, 2010
- Parent breeding period: November 16, 2010 to December 20, 2010
- Age: Juveniles less than 24-hour-old
Parent daphnia breeding conditions
- Culturing method: semi-static type (twice a week, the entire amount of breeding water is changed)
- Water temperature: 20 ± 1 ° C
- Lighting: indoor light, 16 hours light / 8 hours dark (Illumination in the vicinity of the test container: 9 to 15 µmol/mE2/s)
- Food: Leaves of single-celled green algae (algae in the culture solution was collected by centrifugation and replaced with pure water to prepare food)
- Feeding amount: 0.1 to 0.2 mg C (organic carbon)/ day per parent daphnia
- Feeding days: Supplied daily except Saturdays and Sundays, and fed Saturdays and Sundays food on Friday afternoon - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 48 h
- Hardness:
- 250 mg/L (CaCO3)
- Test temperature:
- - Not pH-adjusted test concentrations: 20.4-20.6 °C
- pH-adjusted test concentration: 20.6 °C - pH:
- - Not pH-adjusted test concentrations: 5.8-7.7
- pH-adjusted test concentration: 7.4 - Dissolved oxygen:
- - Not pH-adjusted test concentrations: 8.6
- pH-adjusted test concentration: 8.7 - Salinity:
- n.a.
- Conductivity:
- No data
- Nominal and measured concentrations:
- After 48 hours nominal test concentrations of 35, 45.5, 59, 77 and 100 mg/L equals measured arithmetic mean concentration of 35.7, 46.5, 60.3, 78.8 and 101 mg/L
- Details on test conditions:
- I. Exposure method
- Test solution volume: 90 mL container
- Stations: 4 containers/ test area
- Number of test organisms: 20 heads/test area; 5 test samples in each container
- Test temperature: 20 +/- 1 °C
- Lighting: 16 hours light/8 hours dark
- Aeration: none
- Feeding: None
- Types of auxilaries: None
II. Test containers and equipment
- Test container: 100 mL glass beaker A glass lid was placed on the glass beaker to prevent invasion of the dust and transpiration of the test solution)
- Thermostatic chamber: Constant temperature chamber made by Yamazaki · CEA (configurable temperature: 10 to 30 °C)
- Water thermometer: Mercury rod type standard thermometer (measurement range: 0 to 50 °C, minimum scale: 0.1 °C)
- Dissolved oxygen meter: Do Meter made by Horiba Mochizo (Model: OM12-02)
- pH meter: CANNY ATC PH meter (model: D-21) manufactured by Horiba Seisakusho
- Photon meter: Light meter manufactured by LICOR (model: L1-250
- Total hardness: Korochi Rika Research Laboratory Drop Test Total Hardness WAD-TH
III. Criteria for swimming inhibition:
- After gently moving the test container, it was judged that swimming was inhibited, when swimming never went during 15 seconds of observation - Key result
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- 87.4 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other: (95%-confidence limit 78.7-101 mg/L)
- Remarks:
- without pH-adjustment
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 101 mg/L
- Nominal / measured:
- estimated
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other: (95% confidence interval could not be calculated)
- Remarks:
- with pH-adjustment
- Duration:
- 48 h
- Dose descriptor:
- EC0
- Effect conc.:
- 60 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other:
- Remarks:
- without pH-adjustment
- Duration:
- 48 h
- Dose descriptor:
- EC100
- Effect conc.:
- 101 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other:
- Remarks:
- without pH-adjustment
- Duration:
- 48 h
- Dose descriptor:
- EC0
- Effect conc.:
- 101 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other:
- Remarks:
- with pH-adjustment
- Duration:
- 48 h
- Dose descriptor:
- EC100
- Effect conc.:
- > 101 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other:
- Remarks:
- with pH-adjustment
- Validity criteria fulfilled:
- yes
- Conclusions:
- The acute toxicity of pivalic acid (CAS 75 -98 -9) to Daphnia magna was investigated in a static GLP study following OECD 202. After 48 hours of exposure the EC50 value was 87.4 mg/L (pH not adjusted). In the test system in which the pH-value was adjusted to the pH value ± 0.3 of the control group no swimming inhibition (EC0) was observed in the test system (101 mg/L). The results relate to the arithmetic mean of the measured concentration.
- Executive summary:
A study was performed to assess the acute to Daphnia magna under semi-static conditions. The study was conducted in accordance the OECD Guideline for Testing of Chemicals No. 202 'Daphnia sp., Acute ’Immobilisation Test' (adopted April 13, 2004). A range finding test was performed to get information about the test concentrations in the later main test. In the main test, daphnia were exposed to 5 test concentrations (35, 45.5, 59, 77 and 100 mg/L) relating to nominal concentrations under static exposure conditions. In addition, since the pH value of the test solution fluctuated to the acidic side due to the influence of the test substance, the test was conducted by adding the test concentration group in which the pH value was adjusted to pH - value ± 0.3 of the control group. The temperature, the pH and the oxygen values were measured after 24 and 48 hours of exposure. In the test system without adjustment of the pH value, swimming inhibition of the test organism was observed in the test concentration group of 78.7 and 101 mg/L where the pH value decreased beyond the test condition range (6.0 to 9.0). On the other hand, no swimming inhibition was observed in the test system (101 mg/L) in which the pH value was adjusted to the pH value ± 0.3 of the control group. Therefore, at a concentration of 100 mg/L or less, which is the test upper limit concentration of the test method conforming to the test conducted in conducting the test, the toxicity of the test substance is caused by a decrease in the pH-value accompanying dissolution of the test substance. The pKa-value of the test substance was 4.69 (estimated value). The 48h-EC50 value was 87.4 mg/L (pH not adjusted). The results relate to the arithmetic mean of the measured concentration. This toxicity study is classified as acceptable and satisfies the guideline requirements for the acute Daphnia study.
- Endpoint:
- short-term toxicity to aquatic invertebrates
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- Data from pivalic acid (CAS 75-98-9), which is the hydrolysis product of trimethylacetic anhydride.
- Reason / purpose for cross-reference:
- read-across source
- Specific details on test material used for the study:
- - Purity (GC): 99,9%
- Purity (neutralization titration): 99.7%
- pKa: 4.69 (estimated value)
- Freezing point: 35.0 °C - Key result
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- 87.4 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other: (95%-confidence limit 78.7-101 mg/L)
- Remarks:
- without pH-adjustment
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 101 mg/L
- Nominal / measured:
- estimated
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other: (95% confidence interval could not be calculated)
- Remarks:
- with pH-adjustment
- Duration:
- 48 h
- Dose descriptor:
- EC0
- Effect conc.:
- 60 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other:
- Remarks:
- without pH-adjustment
- Duration:
- 48 h
- Dose descriptor:
- EC100
- Effect conc.:
- 101 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other:
- Remarks:
- without pH-adjustment
- Duration:
- 48 h
- Dose descriptor:
- EC0
- Effect conc.:
- 101 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other:
- Remarks:
- with pH-adjustment
- Duration:
- 48 h
- Dose descriptor:
- EC100
- Effect conc.:
- > 101 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other:
- Remarks:
- with pH-adjustment
- Validity criteria fulfilled:
- yes
- Conclusions:
- The acute toxicity of pivalic acid (75 -98 -9) to daphnia magna was investigated in a static GLP study following OECD 202. After 48 hours of exposure the EC50 value was 87.4 mg/L (pH not adjusted). In the test system in which the pH-value was adjusted to the pH value ± 0.3 of the control group no swimming inhibition (EC0) was observed in the test system (101 mg/L). The results relate to the arithmetic mean of the measured concentration.
Referenceopen allclose all
Description of key information
The acute toxicity of pivalic acid (CAS 75-98-9) to Daphnia magna was investigated in a static GLP study following OECD 202. After 48 hours of exposure the EC50 value was 87.4 mg/L (pH not adjusted). In the test system in which the pH-value was adjusted to the pH value ± 0.3 of the control group no swimming inhibition (EC0) was observed in the test system (101 mg/L). The results relate to the arithmetic mean of the measured concentration.
Key value for chemical safety assessment
Fresh water invertebrates
Fresh water invertebrates
- Effect concentration:
- 87.4 mg/L
Additional information
Read across from toxicity study to aquatic invertebrates of pivalic acid (CAS 75-98-9), which is the hydrolysis product of trimethylacetic anhydride, is possible. Trimethylacetic anhydride ist not stable in water and hydrolyses within hours (For details see chapter 5.1.2).
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.