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EC number: 204-327-1 | CAS number: 119-47-1
- 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:
- 1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- Version / remarks:
- (1992)
- Deviations:
- no
- GLP compliance:
- yes
- Specific details on test material used for the study:
- Details on properties of test surrogate or analogue material: not reported
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: 0.5 and 5.0 mg/L were measured during 96 hours as a limit test.
- Vehicle:
- yes
- Details on test solutions:
- 2,2'-methylenebis(6-tert-butyl-4-methylphenol) was mixed with DMF/Castor oil HCO-40 (3/1(w/w); 20 times weight to the substance) and dissolved into dilution water to prepare the nominal concentration of 5.0 mg/L for exposure (No precipitations as well as emulsions were observed at this nominal concentration). Due to low water solubility of 2,2'-methylenebis(6-tert-butyl-4-methylphenol), homogenous solution could be attained only at (and less than) this nominal concentration with the maximum allowable dispersant concentration of 100 mg/L.
Dilution water: dechlorinated tap water of the city Takarazuka, CaCO3 content of 55.2 mg/L equal 3.1 °dH, pH = 8.1. - Test organisms (species):
- Oryzias latipes
- Details on test organisms:
- Test fish
Acclimated under test condition (water quality, temperature, etc.) for more than 12 days, and no mortality was observed for 7 days before the exposure. Fed daily with commercial fish feed (TetraMin staple food) and starved for 24 hr before the exposure.
The fish body weight and body length measured at the initiation of exposure were 0.17 g (0.16 -0.20 g) and 2.2 cm (2.0 – 2.3 cm) on the average.
The test fish was purchased from a fish farm Izumoto, Osaka on 1998-12-22.
The Batch number was K-981222. - Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 96 h
- Remarks on exposure duration:
- no remarks
- Post exposure observation period:
- not reported
- Hardness:
- 55.2 mg CaCO3/L = 3.1 °dH
- Test temperature:
- ranged from 23.7 to 23.8 °C
- pH:
- ranged from 7.5 to 7.8
- Dissolved oxygen:
- ranged from 5.8 to 8.3 mg/L (more than 60 % saturation)
- Salinity:
- not reported
- Nominal and measured concentrations:
- nominal concentration: 5.0 mg/L
measured value: 4.0 mg/L (initiation of exposure) and 4.3 mg/L after 48 hr of exposure
Note: The geometric mean value was 4.1 mg/L, corresponding to 83 % of the nominal concentration. Thus, the results (e.g. LC50 values) were expressed based on the nominal exposure concentrations. - Details on test conditions:
- TEST SYSTEM
- Test vessel: 5 L glass aquarium (inner size: 21 x 16 x 23 cm)
- No. of organisms per vessel: 10 fish
- No. of vessels per concentration (replicates): one
- No. of vessels per control (replicates): one
- No. of vessels per vehicle control (replicates): one
- Photoperiod: 16 h light / 8 h dark
- Temperature: 24 ± 1 ℃
- Exposure: 96 hours
- Feedind: none - Reference substance (positive control):
- yes
- Remarks:
- Copper sulfate (5 hydrate), lot No.PAH2068 from Wako Pure Chemical Industries, Ltd.
- Duration:
- 24 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 5 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Duration:
- 48 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 5 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Duration:
- 72 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 5 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 5 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Details on results:
- Biological observations/Abnormal responses: Visual inspections of test aquaria (i.e. Control, Solvent control and 5.0 mg/L of Nominal concentration) conducted every 24 h revealed that no toxic symptoms in fish (e.g. abnormal respiration, abnormal swimming, inverted, etc.) were observed during the experiment.
- Results with reference substance (positive control):
- The 96 h-LC50 value determined was 4.0 mg/L.
- Reported statistics and error estimates:
- Due to low water solubility of 2,2'-methylenebis(6-tert-butyl-4-methylphenol), limit exposure experiment with only one nominal concentration was conducted. Thus, no statistical method for the determination of LC50 value was employed. A regression line for GC-MS analyses was derived by least square calculations. Numerical values were rounded according to the method specified in JIS.
- Sublethal observations / clinical signs:
Cumulative mortality
Measured Concentration [mg/L]
Cumulative Number of Dead (Percent Mortality)
24 h
48 h
72 h
96 h
Control
0 (0)
0 (0)
0 (0)
0 (0)
Solvent Control
0 (0)
0 (0)
0 (0)
0 (0)
5.0 mg/L
0 (0)
0 (0)
0 (0)
0 (0)
Highest concentration in 0% mortality/Lowest concentration in 100% mortality:
Exposure period (h)
Highest concentration in 0% mortality
Lowest concentration in 100% mortality
24
5.0
>5.0
48
5.0
>5.0
72
5.0
>5.0
96
5.0
>5.0
- Validity criteria fulfilled:
- yes
- Remarks:
- (-The mortality in the control did not exceed 10 % by the end of the test. - The dissolved oxygen concentration remained above 60 % of the air-saturation value throughout the exposure period. - The pH did not vary by more than 1 unit.)
- Conclusions:
- The acute toxicity of fish (Oryzias latipes) to 2,2'-methylenebis(6-tert-butyl-4-methylphenol) was tested in a semi-static test. After 96 hours of exposure a LC50 more than 5.0 mg/L was observed at a limit test concentration of 5.0 mg/L. No toxic symptoms were observed during the study.
- Executive summary:
A study was performed to assess the acute toxicity of 2,2'-methylenebis(6-tert-butyl-4-methylphenol) to Oryzias latipes under semi-static condition. The study was conducted in accordance to the OECD guideline for Testing of Chemicals No. 203 'Fish, Acute Toxicity Test' (1992).
Due to low water solubility of the substance, the limit experiment was conducted with the maximum dispersable concentration of 5.0 mg/L.
The determined 96 h-LC50 value was more than 5.0 mg/L based on the nominal concentration. No toxic symptoms were observed during the study.
Experimental designs and results were well documented and prescribed conditions in the guideline were well satisfied.
Reference
Description of key information
The key study reported a 96h-LC50 of >5 mg/L (Environmental Agency of Japan, 1999a). The
assessment of DBMC in OECD SIDS (2001) is also based on this value. A further supporting study with embry zebrafish reported a 96h-LC50 value of 1.7 mg/L (Yang et al. 2018).
As the reported LC50 values are above the water solubility no PNEC can be derived based on this result.
Key value for chemical safety assessment
Additional information
The key study (Env. Agency of Japan, 1999a) is assessed in the OECD SIDS Report (2001) and the PBT Report (2009) of the European Chemical Bureau (ECB). This test can be regarded as reliable without restrictions. However the relevant test was performed with a solubilizer in order to overcome the low water solubility of 0.007 mg/L. As a consequence, no effects have been observed up to the limit of the water solubility.
The lowest 96h-LC50 is reported to be 1.7 mg/L (Yang et al. 2018). In this study, 0.1% of solvent (DMSO) was used in order to obtain test concentrations well above the water solubility.
No PNEC can be derived based on this result.
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