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EC number: 248-383-5 | CAS number: 27277-00-5
- 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:
- 02 Mar 1978 to 29 May 1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- according to guideline
- Guideline:
- other: Kanppo Gyo No5 (Environmental Agency), Yakuhatsu No 615 (Ministry of Health and Welfare) and 49 Kiyoku No 392 (Ministry of International Trade and Industry)
- Version / remarks:
- Method for testing the degree of accumulation of chemical substances in fish body.
- GLP compliance:
- no
- Radiolabelling:
- no
- Details on sampling:
- Extracts with chloroform from test water of both groups were prepared twice (10 minutes shaking). The chloroform fractions were dehydrated (IPS filter paper), condensed by a rotary evaporator and made up to mL with chloroform before HLC analysis.
- Vehicle:
- no
- Details on preparation of test solutions, spiked fish food or sediment:
- 2000 ppm (w/v) standard solution is prepared by dissolving 2g of the test compound in water and making it up to 1 L.
- Test organisms (species):
- other: carp (not further specified)
- Details on test organisms:
- TEST ORGANISM
- Weight at study initiation: 29 g
- Length at study initiation: 11 cm
- External sterilising: Fish are kept in steriliser bath (10 ppm solution of chlorotetracycline - HCl) for 24 hours
- Acclimation: At 25 °C for 14 days - Route of exposure:
- aqueous
- Justification for method:
- other: not specified
- Test type:
- flow-through
- Water / sediment media type:
- natural water: freshwater
- Total exposure / uptake duration:
- 8 wk
- Test temperature:
- 23 - 27 °C
- Details on test conditions:
- TEST SYSTEM
- Test vessel: 100 L aquarium
- Type: Flow through
- Inflow: 576 L/day - Nominal and measured concentrations:
- - Group 1: 0.2 ppm (w/v)
- Group 2: 0.02 ppm (w/v)
See 'Any other information on materials and methods incl. tables' for the analysed concentrations during the test. - Reference substance (positive control):
- no
- Details on estimation of bioconcentration:
- TREATMENT OF THE SAMPLE
At exposure termination, fish were weighed, slit into pieces and homogenised with the aid of 15 g of sea sand by addition of 100 g of anhydrous Sodium Sulphate. This was dehydrated, extracted with150 mL of chloroform (10 min shaken) and filtered by a glass filter G 4 (twice). The chloroform fractions were then dehydrated (1 ps filter paper) and condensed by a rotary evaporator. 10 mL of benzene was added and the solution was purified by column chromatograph (see HLC conditions below). The fractions were then condensed by a rotary evaporator and made up to 10 mL with chloroform.
HLC SPECIFICATIONS
- Filler: 10g of 3% hydrated Alumina (I C N Co Ltd) with benzene
- Column: 20 mm diameter glass tube
- Eluent: Fraction 1: 100 mL benzene; Fraction 2: 100 mL 20% chloroform/benzene; Fraction 3: 50% chloroform/benzene
The test item elutes to fraction 3. - Conc. / dose:
- 0.2 other: ppm
- Temp.:
- 25 °C
- Type:
- BCF
- Value:
- >= 0.2 - <= 1.6 dimensionless
- Basis:
- not specified
- Time of plateau:
- 8 wk
- Calculation basis:
- kinetic, corrected for growth
- Remarks on result:
- other: See 'Any other information on results incl. tables'
- Conc. / dose:
- 0.02 other: ppm
- Temp.:
- 25 °C
- Type:
- BCF
- Value:
- 5.5 dimensionless
- Basis:
- not specified
- Time of plateau:
- 8 wk
- Calculation basis:
- kinetic, corrected for growth
- Remarks on result:
- other: See 'Any other information on results incl. tables'
- Details on results:
- Results on the degree of accumulation is given in 'Any other information on results incl tables'. The highest accuracy is expected for analysis when the concentration of the test item is around 1.6 ppm. In the case that a fish has 30 g body weight, 10 mL of final extract is used for analysis and the recovery rate is estimated as 80 %, the degree of accumulation can be recalculated as follows in the fish body:
1.6 ppm/0.8*30/10 = 0.67 ppm
Equally the analytical limit of the test item, 0.1 ppm (signal/Noise = 2 : Noise = 1 mm) accounts for 0.04 ppm as the concentration in fish body. Therefore, the degree of accumulation of the fish with the test item level of 0.04 - 0.67 ppm is indicated as a reference in the parathesis and with the level of less than 0.04 ppm, it is indicated as <0.2 or >2.
RECOVERY
- Recovery blanks: 81.3 - 98.8 %
- Recovery group 1: 95.4%
- Recovery group 2: 81.5% - Validity criteria fulfilled:
- not specified
- Conclusions:
- At a concentration of 0.2 and 0.02 ppm, the bioaccumulation factor ranged between 0.2 - 1.6 and <2 - 5.5, respectively, over 8 weeks in carp.
Reference
Table: Degree of bioaccumulation/ Accumulation factor (L)
|
2 Weeks |
4 Weeks |
6 Weeks |
8 Weeks |
Group 1 |
(0.6) |
0.2 |
(0.5) |
(1.1) |
(0.6) |
(0.3) |
(0.8) |
(1.6) |
|
Group 2 |
< 2 |
< 2 |
< 2 |
< 2 |
< 2 |
< 2 |
< 2 |
(5.5) |
The degree of accumulation of the fish with the test item level of 0.04 - 0.67 ppm is indicated as a reference in the parathesis and with the level of less than 0.04 ppm, it is indicated as <0.2 or >2.
Table: Details on fish analysis results – 1
Sample |
A - Injetion volume |
B - Σ height (mm) |
D - Apparent Conc. On chart (pp,) |
E - Dilution factor |
F - Final volume (mL) |
G - Absolute amount in fish (µg) |
H - Fish weight (g) |
I - Recovery (%) |
J - Conc. in fish (ppm) |
K - Conc. In aquarium (ppm) |
L - Accumulation factor |
Injection fish |
|
M - Conc. (ppm) |
N - Volume (mL) |
||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
100 |
0.3 |
Standard 2.5 ppm |
60 |
92.6 |
|
|
|
|
|
|
|
|
|
(30 µg) |
|
Fish recovery group 2a |
60 |
73.8 |
1.99 |
1.0 |
10.0 |
19.9 |
|
66.4 |
|
|
|
|
|
Fish recovery group 2b |
60 |
66.7 |
1.80 |
1.0 |
10.0 |
18.0 |
|
60.0 |
|
|
|
|
|
|
|
|
|
|
|
|
Ava. |
63.2 |
|
|
|
|
|
Standard 2.5 ppm |
60 |
93.2 |
|
|
|
|
|
|
|
|
|
|
|
Fish blank a |
60 |
nd |
- |
1.0 |
10.0 |
- |
|
|
|
|
|
|
|
Fish blank b |
60 |
nd |
- |
1.0 |
10.0 |
- |
|
|
|
|
|
|
|
Table: Details on fish analysis results – 2
Sample |
A - Injetion volume |
B - Σ hight (mm) |
D - Apparent Conc. On chart (pp,) |
E - Dilution factor |
F - Final volume (mL) |
G - Absolute amount in fish (µg) |
H - Fish weight (g) |
I - Recovery (%) |
J - Conc. in fish (ppm) |
K - Conc. In aquarium (ppm) |
L - Accumulation factor |
Injection fish |
|
M - Conc. (ppm) |
N - Volume (mL) |
||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Standard 2.5 ppm |
60 |
96.4 |
|
|
|
|
|
|
|
|
|
|
|
Fish 2 week group 1 |
60 |
7.2 |
0.187 |
1 |
10 |
1.87 |
25.4 |
63.2 |
0.116 |
0.184 |
0.6 |
|
|
Fish 2 week group 1 |
60 |
8 |
0.207 |
1 |
10 |
2.07 |
31.3 |
63.2 |
0.105 |
0.184 |
0.6 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Standard 2.5 ppm |
60 |
94.7 |
|
|
|
|
|
|
|
|
|
|
|
Fish 4 week group 1 |
60 |
2.4 |
0.064 |
1 |
10 |
0.634 |
27.5 |
63.2 |
0.036 |
0.186 |
0.2 |
|
|
Fish 4 week group 1 |
60 |
4.3 |
0.114 |
1 |
10 |
1.14 |
28.7 |
63.2 |
0.063 |
0.186 |
0.3 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Standard 2.5 ppm |
60 |
94.6 |
|
|
|
|
|
|
|
|
|
|
|
Fish 6 week group 1 |
60 |
6.8 |
0.18 |
1 |
10 |
1.8 |
29.2 |
63.2 |
0.097 |
0.18 |
0.5 |
|
|
Fish 6 week group 1 |
60 |
9.3 |
0.246 |
1 |
10 |
2.46 |
27.4 |
63.2 |
0.142 |
0.18 |
0.8 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Standard 2.5 ppm |
60 |
77.2 |
|
|
|
|
|
|
|
|
|
|
|
Fish 8 week group 1 |
60 |
11.7 |
|
1 |
10 |
3.79 |
30.2 |
63.2 |
0.199 |
0.179 |
1.1 |
|
|
Fish 8 week group 1 |
60 |
17.6 |
|
1 |
10 |
5.7 |
31.4 |
63.2 |
0.287 |
0.179 |
1.6 |
|
|
Table: Details on fish analysis results – 3
Sample |
A - Injetion volume |
B - Σ hight (mm) |
D - Apparent Conc. On chart (pp,) |
E - Dilution factor |
F - Final volume (mL) |
G - Absolute amount in fish (µg) |
H - Fish weight (g) |
I - Recovery (%) |
J - Conc. in fish (ppm) |
K - Conc. In aquarium (ppm) |
L - Accumulation factor |
Injection fish |
|
M - Conc. (ppm) |
N - Volume (mL) |
||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Standard 2.5 ppm |
60 |
95.9 |
|
|
|
|
|
|
|
|
|
|
|
Fish 2 week group 2a |
60 |
nd |
- |
1 |
10 |
- |
27 |
63.2 |
- |
0.024 |
- |
|
|
Fish 2 week group 2b |
60 |
nd |
- |
1 |
10 |
- |
27.2 |
63.2 |
- |
0.024 |
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Standard 2.5 ppm |
60 |
95.3 |
|
|
|
|
|
|
|
|
|
|
|
Fish 4 week group 2a |
60 |
nd |
- |
1 |
10 |
- |
28.5 |
63.2 |
- |
0.024 |
- |
|
|
Fish 4 week group 2b |
60 |
nd |
- |
1 |
10 |
- |
30.1 |
63.2 |
- |
0.024 |
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Standard 2.5 ppm |
60 |
93.2 |
|
|
|
|
|
|
|
|
|
|
|
Fish 6 week group 2a |
60 |
nd |
- |
1 |
10 |
- |
33.2 |
63.2 |
- |
0.023 |
- |
|
|
Fish 6 week group 2b |
60 |
nd |
- |
1 |
10 |
- |
28 |
63.2 |
- |
0.023 |
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Standard 2.5 ppm |
60 |
78.3 |
|
|
|
|
|
|
|
|
|
|
|
Fish 8 week group 2a |
60 |
nd |
- |
1 |
10 |
- |
23.2 |
63.2 |
- |
0.023 |
- |
|
|
Fish 8 week group 2b |
60 |
7 |
0.223 |
1 |
10 |
2.23 |
28.1 |
63.2 |
0.126 |
0.023 |
5.5 |
|
|
Description of key information
BCF of 0.2 - 5.5, Japanese test guideline, ICI Japan Ltd.
Key value for chemical safety assessment
Additional information
The bioaccumulation potential of the test material was investigated in fish in a non-GLP study according to Japanese guidelines Kanppo Gyo No5 (Environmental Agency), Yakuhatsu No 615 (Ministry of Health and Welfare) and 49 Kiyoku No 392 (Ministry of International Trade and Industry) (Chemicals Inspection & Testing Institute, Japan, 1978). Two groups of carp (species unknown) were exposed to concentrations of 0.2 and 0.02 ppm to the test material for 8 weeks in a flow-through aquarium with an inflow of 576 L/day. After 2, 4, 6 and 8 weeks of exposure, analytical verification of the test material in water and fish was performed using HPLC analysis. The recovery of the test material was determined to be ≥80%. Based on the results, it was calculated that at a concentration of 0.2 and 0.02 ppm, the bioaccumulation factor ranged between 0.2 - 1.6 and <2 - 5.5, respectively, over 8 weeks in carp.
The two main impurities of the substance have predicted log Kow values of 2.31 and 2.48 (calculated with ACD/Labs, values as given in SciFinder), and the bioconcentration factors calculated with the bioaccumulation tool in US EPA Episuite 4 (BCFBAF v3.01) are 8.75 to 14.7 L/kg and 17.1 to 21.5 L/kg). These values show that also the impurities of the substance are unlikely to accumulate in biota to a significant extent.
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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