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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 228-846-8 | CAS number: 6362-80-7
- 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
Bioaccumulation: aquatic / sediment
Administrative data
Link to relevant study record(s)
- Endpoint:
- bioaccumulation in aquatic species: fish
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Start of study: 14 December 2001; End of study: 15 April 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study conducted according to GLP
- Qualifier:
- according to guideline
- Guideline:
- other: Test Method Relating to New Chemical Substances (Kanpogyo No. 5, Yakuhatsu No. 615, 49 Kikyoku No. 392, 1974; partially revised 1998)
- GLP compliance:
- yes
- Radiolabelling:
- no
- Details on sampling:
- Test water:
Samples were taken at the start (day 0) and days 7, 14, 21, 28, 35, 42, 49 and 60 of uptake, and test substance concentration was measured.
Fish:
After the start of uptake, 4 common carp were sampled on days 7, 14, 28 and 42 and 6 common carp on day 60, and test substance concentration was measured in 2 fish twice.
In addition, analysis by site was performed using the two remaining fish sampled at the end of uptake (day 60).
Because the concentration rate exceeded 1000, an elimination test was conducted using the fish remaining on day 60 of uptake. Four fish from each concentration were sampled on days 2, 4, 9 and 16 after start of elimination, and test substance concentration was measured by the same method as during the uptake period
- Test organisms (species):
- Cyprinus carpio
- Details on test organisms:
- TEST ORGANISM
- Common name: Common carp
- Source: Sankyou-Suisan Co. Ltd. (1-1 Ichigayata-machi, Shinjuku-ku, Tokyo)
- Age at study initiation: Within 1 year after hatching
- Length at study initiation: 8±4 cm
- Weight at study initiation: About 5 g
ACCLIMATION
- Acclimation period: At least 2 weeks
- Type and amount of food: Kyorin Baby Gold
- Feeding frequency: Approximately 2% of body weight every day
- Health during acclimation (any mortality observed): Mortality rate in the week before the test was less than 5% - Route of exposure:
- feed
- Total exposure / uptake duration:
- 60 d
- Total depuration duration:
- 16 d
- Test temperature:
- 24 ± 2 °C
- pH:
- 6.0.8.5
- Dissolved oxygen:
- 60% of saturated dissolved oxygen or more (5 mg/L or more at 24°C)
- Details on test conditions:
- TEST SYSTEM
- Test vessel: 56 L glass aqaurium
- Fill volume: 50 L
- Renewal rate of test solution (frequency/flow rate): 800 L/day (water exchanged 16 times/day)
- Biomass loading rate: High concentration 1: 44 fish/50L test water (1.0 g per liter/day or more)
Low concentration 2: 44 fish/50 L test water (1.0 g per liter/day or more)
Control: 24 fish/50 L test water (1.0 g per liter/day or more)
OTHER TEST CONDITIONS
- Photoperiod: About 16 hr/day
- Light intensity: Hf fluorescent lamps (wavelength 400 -700 nm)
RANGE-FINDING / PRELIMINARY STUDY
Acute toxicity test:
The 96 hr-LC50was measured according to the OECD Guideline for Testing of Chemicals Test No.203: Fish, Acute Toxicity Test. The result (LC50) was calculated from the nominal concentration without measuring the concentration of the test substance in the test solution.
Test Fish
Species: Medaka (Oryzias latipes, Cyprinodontidae)
Source: Sankyou-Suisan Co. Ltd.
(1-1 Ichigayata-machi, Shinjuku-ku,)
Date of receipt: 12 November 2001
Lot number: 01-H-1112
Preliminary treatment: The fish were visually inspected upon receipt, those with abnormalities were removed, and the rest were kept in flowing water.
Total length: 2±1 cm
Body weight: About 0.2 g
Acclimatization
Tank number: B-8
Water temperature: 24±2°C
Duration: At least 2 weeks
Type of feed: Tetrawerke Tetramin
Amount of feed: 2% of body weight (every day, but not fed for 24 hours before the test)
Mortality rate in the week before the test: Less than 5%
Test Conditions
Test concentrations: 0 (control), 1.0 mg/L
Rearing density: 10 fish/concentration
Volume of test water: 3.0 L
Water temperature: 24±2°C
Water exchange: No
Aeration: Yes
Percent of dissolved oxygen: ≥60% of saturated dissolved oxygen
Amount of feed: No
Test period: 96 hours
Preparation of test water
Test group:
Approximately 500 mg of the test substance was dissolved in 40% (w/v) HCO-40/2 methoxyethanol solution and made up to 25 mL. 0.15 mL of this solution was collected and dispersed and dissolved in the dilution water while stirring to make 3 L (test substance concentration: 1.0 mg/L, HCO-40 concentration: 20 mg/L, 2 methoxyethanol concentration:»30 ppm (v/v)).
Control group:
0.15 mL of 40% (w/v) HCO-40/2 methoxyethanol solution was collected, dissolved in dilution water and made up to 3 L (HCO-40 concentration: 20 mg/L, 2 methoxyethanol concentration:»30 ppm (v/v)).
The 96 hr-LC50of the test substance was >1.0 mg/L. From the results of the acute toxicity test, the concentrations of test substance in the test water in the concentration test were set at 0.01 and 0.001 mg/L, which are less than 1/100 and 1/1000 of the 96 hr-LC50value - Nominal and measured concentrations:
- High concentration 1: 0.01 mg/L (Auxiliary HCO-40: 0.2 mg/L, 2-methoxyethanol: ~25 ppm (v/v))
Low concentration 2: 0.001 mg/L (Auxiliary HCO-40: 0.02 mg/L, 2-methoxyethanol: ~25 ppm (v/v))
Control: 0 mg/L (Auxiliary HCO-40: 0.2 mg/L, 2-methoxyethanol: ~25 ppm (v/v)) - Reference substance (positive control):
- no
- Details on estimation of bioconcentration:
- Calculation of concentration rate:
The concentration rate at each measurement time was calculated by the following equation.
BCF = Cf at each measurement time / Cw up to each measurement time (mean)
If steady state was attained, the concentration rate at steady state was calculated by the following equation.
BCFss = Cf at steady state (mean) / Cw at steady state (mean)
BCF: Concentration rate at each measurement time
BCFss: Concentration rate at steady state
Cf: Concentration in fish (μg/g)
Cw: Concentration in water (mg/L)
Steady state: Steady state is attained when the variation of the concentration rate in three successive measurements in a period of 48 hours or more is 20% or less. The mean Cf and Cw are calculated from the final three successive measurements up to the end of uptake. However, if the concentration rate during the test period is less than 100, steady state is not considered to have been attained even if variation of the concentration rate is 20% or less. In that case, BCFss is not calculated.
Limit of concentration rate measurement
The test substance was not detected in the blank test on fish, and the detection limit was <0.012 μg/g. While it differs depending of fish body weight, the concentration rate can be measured when the concentration is about 2-fold or more at the nominal concentration in test water of 0.01 mg/L (high concentration 1) and about 12-fold or more at 0.001 mg/L (low concentration 2). - Lipid content:
- 6.1 %
- Time point:
- start of exposure
- Remarks on result:
- other:
- Remarks:
- The protocol stated that fish for measurement of lipid content would be collected at the start of uptake and the end of elimination test if an elimination test is conducted. Actually, the samples which should have been collected at the end of the elimination test were collected at the end of uptake. Mean lipid content at the end of uptake was within ±25% of that at the start. The elimination test period was 16 days, and variation of lipid content was probably small because it was shorter than the uptake period. Therefore, it was judged to have no effect on the test results.
- Lipid content:
- 7.3 %
- Time point:
- end of exposure
- Remarks on result:
- other:
- Remarks:
- The protocol stated that fish for measurement of lipid content would be collected at the start of uptake and the end of elimination test if an elimination test is conducted. Actually, the samples which should have been collected at the end of the elimination test were collected at the end of uptake. Mean lipid content at the end of uptake was within ±25% of that at the start. The elimination test period was 16 days, and variation of lipid content was probably small because it was shorter than the uptake period. Therefore, it was judged to have no effect on the test results.
- Key result
- Conc. / dose:
- 0.01 mg/L
- Temp.:
- >= 22 - <= 26 °C
- Type:
- BCF
- Value:
- >= 427 - <= 3 330 dimensionless
- Calculation basis:
- steady state
- Remarks:
- Due to the variation in concentration rate in three successive measurements up to the end of uptake did not attain less than 20%, despite correction for 4% lipid concentration, the concentration rate at steady state (BCFss) was not calculated.
- Key result
- Conc. / dose:
- 0.001 mg/L
- Temp.:
- >= 22 - <= 26 °C
- Type:
- BCF
- Value:
- >= 423 - <= 4 410 dimensionless
- Calculation basis:
- steady state
- Remarks:
- Due to the variation in concentration rate in three successive measurements up to the end of uptake did not attain less than 20%, despite correction for 4% lipid concentration, the concentration rate at steady state (BCFss) was not calculated.
- Details on results:
- Environmental Factors which could Affect the Reliability of Test Results
There were no such events.
Management of Study Fish
During the experimental period, the percent of dissolved oxygen in all water tanks was 60% of the saturated dissolved oxygen and water temperature was 24±2°C, which both conformed to the test conditions. pH was within the appropriate range (6.0-8.5) of the environment for fish. Mortality and abnormality were <10% at each concentration during the experimental period. It was also confirmed that the fish were raised normally since there were no abnormalities in shape, swimming or feed intake in the surviving fish during the experimental period.
Lipid content (control group): Start: 6.1% (n=3, 6.0-6.2%) End: 7.3% (n=3, 6.5-8.2%)
(Mean lipid content at the end was within ±25% of that at the start.)
Lipid content in stock samples for measurement of lipid content:
Uptake period: High concentration 1: 5.5% (1.2-7.7%), Low concentration 2: 5.1% (3.0-6.7%)
Elimination period: High concentration 1: 2.9% (0.9-4.3%), Low concentration 2: 3.6% (2.4-5.8%)
Test Substance Concentration in Test Water
same as nominal values, 0.01048 mg/L for high concentration 1 and 0.000929 mg/L for low concentration 2. The coefficient of variation was 7.8% and 11.1%, respectively. Variation of test substance concentration in test water was within ±20% of the mean measured value.
Test Substance Concentration and Concentration Rate in Fish:
Concentrations in fish during the uptake period were 4.25-35.05 μg/g at high concentration 1 and 0.429-4.165 μg/g at low concentration 2. The concentration rate (BCF) was 427-3330 at high concentration 1 and 423-4410 at low concentration 2. Because variation in the concentration rate (mean) in three successive measurements up to the end of uptake exceeded 20% for high concentration 1 and low concentration 2, the concentration rate was calculated with correction for 4% lipid content.
Because the variation in the concentration rate (mean) in three successive measurements up to the end of uptake did not attained less than 20% despite correction for 4% lipid concentration, the defined level for steady state was not attained and the concentration rate at steady state (BCFss) was not calculated.
Concentration Rate by Site:
In order to examine the site of test substance concentration, the head, viscera, edible parts (muscle, bone) and outer skin (skin, fins) of two fish at each concentration were dissected and analyzed on day 60 after the start of uptake by the method of 5.5. At high concentration 1, the concentration rate in the head was relatively high compared to the other sites, and low in the edible parts. At low concentration 2, it was high in the viscera and low in the edible parts.
Elimination Test
An elimination test was conducted after the end of uptake since the concentration rate exceeded 1000. During the elimination test the concentration of test substance in the fish decreased over time, and the biological half-life (BHL) was calculated to be 4.5 days at high concentration 1 and 15.7 days at low concentration 2. - Validity criteria fulfilled:
- not specified
- Conclusions:
- Based on the results of the study the test substance should be considered as bioaccumulative.
Reference
The results of measurement of concentration rate are shown below.
Uptake period |
Day 7 |
Day 14 |
Day 28 |
Day 42 |
Day 60 |
|
High concentration 1 |
Mean concentration in water (mg/L) |
0.00995 |
0.01007 |
0.01033 |
0.01054 |
0.01048 |
Concentration rate 1 |
1610 |
957 |
1370 |
896 |
1080 |
|
BCF 427~3330 2 |
427 |
1950 |
2810 |
3330 |
1250 |
|
Low concentration 2 |
Mean concentration in water (mg/L) |
0.001013 |
0.000982 |
0.000943 |
0.000944 |
0.000929 |
Concentration rate 1 |
469 |
1610 |
3730 |
4410 |
724 |
|
BCF 423~4410 2 |
423 |
1740 |
2270 |
4120 |
2220 |
The concentration rates corrected for 4% lipid content are shown below
Uptake period |
Day 7 |
Day 14 |
Day 28 |
Day 42 |
Day 60 |
|
High concentration1 |
Concentration rate 1 |
836 |
580 |
913 |
1330 |
960 |
BCFL4 294~4170 2 |
294 |
1050 |
1840 |
1900 |
4170 |
|
High concentration 2 |
Concentration rate 1 |
323 |
1040 |
2930 |
3750 |
724 |
BCFL4 323~3750 2 |
564 |
1740 |
1360 |
2460 |
2070 |
Concentration rates in each site were as follows:
Site |
High concentration 1 (day 60) |
Low concentration 2 (day 60) |
Head Viscera Edible parts Outer skin |
3660 2340 1510 1660 |
3340 5190 1610 2890 |
Description of key information
Based on the results of the study the test substance should be considered as bioaccumulative.
Key value for chemical safety assessment
- BCF (aquatic species):
- 4 410 dimensionless
Additional information
Introduction
The bioaccumulative potential of the test item was assessed according to the test method relating to New Chemical Substances (Kanpogyo No. 5, Yakuhatsu No. 615, 49 Kikyoku No. 392, 1974; partially revised 1998).
Discussion
Concentrations in the fish during the uptake period were 4.25-35.05 μg/g at high concentration 1 and 0.429-4.165 μg/g at low concentration 2. The concentration rate (BCF) was 427-3330 at high concentration 1 and 423-4410 at low concentration 2. Concentration rates corrected for 4% lipid content were calculated because variation in the concentration rate (mean) exceeded 20% in three successive measurements up to the end of the uptake period at high concentration 1 and low concentration 2.
Despite correction for 4% lipid content, variation in the concentration rate (mean) in three successive measurements up to the end of the uptake period did not become 20% or less, and because the defined level for steady state was not attained, the concentration rate at the steady state (BCFSS) was not calculated.
In order to examine the site of test substance concentration, the head, viscera, edible parts (muscle, bone) and outer skin (skin, fins) of two fish at each concentration were dissected and analyzed on day 60 after the start of uptake. At high concentration 1, the concentration rate in the head was relatively high compared to the other sites, and low in the edible parts. At low concentration 2, it was high in the viscera and low in the edible parts.
Concentration rates in each site were as follows.
Site |
High concentration 1 (day 60) |
Low concentration 2 (day 60) |
Head |
3660 |
3340 |
Viscera |
2340 |
5190 |
Edible parts |
1510 |
1610 |
Outer skin |
1660 |
2890 |
An elimination test was conducted after the end of uptake since the concentration rate exceeded 1000. During the elimination test the concentration of test substance in the fish decreased over time, and the biological half-life (BHL) was calculated to be 4.5 days at high concentration 1 and 15.7 days at low concentration 2.
Results
The results of measurement of concentration rate are shown below.
Uptake period |
Day 7 |
Day 14 |
Day 28 |
Day 42 |
Day 60 |
||
High concentration 1 |
Mean concentration in water (mg/L) |
0.00995 |
0.01007 |
0.01033 |
0.01054 |
0.01048 |
|
Concentration rate |
1 |
1610 |
957 |
1370 |
896 |
1080 |
|
BCF 427- 3330 |
2 |
427 |
1950 |
2810 |
3330 |
1250 |
|
Low concentration 2 |
Mean concentration in water (mg/L) |
0.001013 |
0.000982 |
0.000943 |
0.000944 |
0.000929 |
|
Concentration rate |
1 |
469 |
1610 |
3730 |
4410 |
724 |
|
BCF 423- 4410 |
2 |
423 |
1740 |
2270 |
4120 |
2220 |
The concentration rates corrected for 4% lipid content are shown below.
Uptake period |
Day 7 |
Day 14 |
Day 28 |
Day 42 |
Day 60 |
||
High concentration 1 |
Concentration rate |
1 |
836 |
580 |
913 |
1330 |
960 |
BCFL4 294- 4170 |
2 |
294 |
1050 |
1840 |
1900 |
4170 |
|
Low concentration 2 |
Concentration rate |
1 |
323 |
1040 |
2930 |
3750 |
724 |
BCFL4 323- 3750 |
2 |
564 |
1740 |
1360 |
2460 |
2070 |
Based on the results of the study the test substance should be considered as bioaccumulative.
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.