Registration Dossier
Registration Dossier
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EC number: 902-591-9 | CAS number: -
Bioaccumulation: aquatic / sediment
Administrative data
Link to relevant study record(s)
- Endpoint:
- bioaccumulation in aquatic species: fish
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because the substance has a low potential for bioaccumulation based on log Kow <=3
- Endpoint:
- bioaccumulation in aquatic species: fish
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- no guideline followed
- Key result
- Type:
- BCF
- Value:
- < 10
- Details on kinetic parameters:
- no data
- Metabolites:
- no data
- Results with reference substance (positive control):
- no data
- Details on results:
- no data
- Reported statistics:
- no data
- Endpoint:
- bioaccumulation in aquatic species: fish
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- no guideline followed
- Radiolabelling:
- yes
- Key result
- Type:
- BCF
- Value:
- 1
- Basis:
- other: blood and tissues (gill, muscle, liver, kidney, intestine)
- Remarks on result:
- other: Conc.in environment / dose:5 mg/L
- Key result
- Type:
- BCF
- Value:
- 1
- Basis:
- other: muscle
- Remarks on result:
- other: Conc.in environment / dose:5 mg/L
- Type:
- BCF
- Value:
- 3
- Basis:
- other: gills, liver, kidney
- Remarks on result:
- other: Conc.in environment / dose:5 mg/L
- Type:
- BCF
- Value:
- 4.5
- Basis:
- other: intestine
- Remarks on result:
- other: Conc.in environment / dose:5 mg/L
- Endpoint:
- bioaccumulation in aquatic species: fish
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Type:
- BCF
- Value:
- 0.2
- Basis:
- not specified
- Endpoint:
- bioaccumulation in aquatic species: fish
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Remarks:
- Data from Handbook or collection of data, no data on methods are provided
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Handbook data
- GLP compliance:
- no
- Radiolabelling:
- not specified
- Details on sampling:
- no data
- Vehicle:
- not specified
- Details on preparation of test solutions, spiked fish food or sediment:
- no data
- Test organisms (species):
- Leuciscus idus melanotus
- Details on test organisms:
- no data
- Route of exposure:
- aqueous
- Test type:
- not specified
- Water / sediment media type:
- natural water: freshwater
- Hardness:
- no data
- Test temperature:
- no data
- pH:
- no data
- Dissolved oxygen:
- no data
- TOC:
- no data
- Salinity:
- no data
- Details on test conditions:
- no data
- Nominal and measured concentrations:
- no data
- Reference substance (positive control):
- not specified
- Details on estimation of bioconcentration:
- no data
- Key result
- Type:
- BCF
- Value:
- 0.2
- Basis:
- not specified
- Details on kinetic parameters:
- no data
- Metabolites:
- no data
- Results with reference substance (positive control):
- no data
- Details on results:
- no data
- Reported statistics:
- no data
- Endpoint:
- bioaccumulation in aquatic species: fish
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The amount of radioactivity derived from 14-C-labelled methanol was determined in the liver, kidneys, intestine, muscle, blood and gills after exposure to carp.
- GLP compliance:
- not specified
- Radiolabelling:
- yes
- Details on sampling:
- - Sampling intervals/frequency for test organisms: three fishes at 6, 24, and 72 hours
- Sampling intervals/frequency for test medium samples: 0, 6, 24, and 72 hours - Vehicle:
- yes
- Details on preparation of test solutions, spiked fish food or sediment:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): ethanol
- Concentration of vehicle in test medium (stock solution and final test solution(s) at different concentrations and in control(s)): 1 mL/L
- Evidence of undissolved material (e.g. precipitate, surface film, etc): no - Test organisms (species):
- Cyprinus carpio
- Details on test organisms:
- TEST ORGANISM
- Common name: carp
- Source: commercial dealer
- Length at study initiation (length definition, mean, range and SD): 12 - 17 cm
- Weight at study initiation (mean and range, SD): 40 - 80g
- Weight at termination (mean and range, SD):
- Description of housing/holding area: large tanks, at 12°C, filtered tap water, fed daily on carp diet
- Feeding during test
- not fed 2 days before and during test
ACCLIMATION
- Acclimation period: 4 weeks; 2 weeks before test they were brought to test aquaria
- Acclimation conditions (same as test or not): no
- Type and amount of food: commercial carp pellets
- Feeding frequency: daily
- water renewal: 2/3 every 2 days - Route of exposure:
- aqueous
- Test type:
- static
- Water / sediment media type:
- natural water: freshwater
- Total exposure / uptake duration:
- 72 h
- Total depuration duration:
- h
- Test temperature:
- 20°C
- Details on test conditions:
- TEST SYSTEM
- Test vessel:
- Type (delete if not applicable): 25 L aquaria
- Aeration: yes
- No. of organisms per vessel: 9
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: tap water - Nominal and measured concentrations:
- 5 mg/L
- Reference substance (positive control):
- not specified
- Details on estimation of bioconcentration:
- - Results from residue study: based on original compound indicated by radioactivity
- Key result
- Type:
- BCF
- Value:
- 1
- Basis:
- other: blood and tissues (gill, muscle, liver, kidney, intestine)
- Remarks on result:
- other: Conc.in environment / dose:5 mg/L
- Key result
- Type:
- BCF
- Value:
- 1
- Basis:
- other: muscle
- Remarks on result:
- other: Conc.in environment / dose:5 mg/L
- Type:
- BCF
- Value:
- 3
- Basis:
- other: gills, liver, kidney
- Remarks on result:
- other: Conc.in environment / dose:5 mg/L
- Type:
- BCF
- Value:
- 4.5
- Basis:
- other: intestine
- Remarks on result:
- other: Conc.in environment / dose:5 mg/L
- Endpoint:
- bioaccumulation in aquatic species: fish
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- Test duration doesn' t correspond to exposure duration in guideline studies. However due to the low log Kow of ethanol the results of the study are to be considered as reliable.
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The bioconcentration factor of methanol was experimentally measured in fish (golden orfe)
- GLP compliance:
- not specified
- Radiolabelling:
- yes
- Vehicle:
- not specified
- Test organisms (species):
- Leuciscus idus melanotus
- Details on test organisms:
- TEST ORGANISM
- Common name: golden orfe
- Feeding during test: no - Route of exposure:
- aqueous
- Test type:
- not specified
- Water / sediment media type:
- natural water: freshwater
- Total exposure / uptake duration:
- 72 h
- Reference substance (positive control):
- not specified
- Details on estimation of bioconcentration:
- - BCF calculated according to: concentration of methanol in fish (µg/g) / medium concentration of methanol in water (µg/g)
- Key result
- Type:
- BCF
- Value:
- < 10
- Details on kinetic parameters:
- no data
- Metabolites:
- no data
- Results with reference substance (positive control):
- no data
- Details on results:
- no data
- Reported statistics:
- no data
Referenceopen allclose all
The BCF of methanol experimentally measured in fish (golden ide) was less than 10. Based on the octanol/water partition coefficient, the BCF value for methanol can be estimated to be 0.2 from a recommended regression-derived equation.
The initial uptake of methanol into the different tissue types was the same after 24 hours, and levels remained constant over 72 hours in the liver, kidneys, gills and intestine but dropped slightly in the blood and muscle. Bioaccumulation factors of about 1 were proposed for the fish tissues and organs.
The bioconcentration factor of methanol experimentally measured in fish (golden orfe) was less than 10. Due to a low Log Kow of -0.82 (Hansch and Leo 1979) accumulation in organisms is not to be expected.
Description of key information
The study does not need to be conducted because the registration substance has a low potential for bioaccumulation based on log Pow <= 3 (study scientifically not necessary). However, based on a read across to the source substance Methanol a BCF <10 was derived.
Key value for chemical safety assessment
Additional information
In accordance with column 2 of Annex IX to Regulation (EC) No 1907/2006 (REACH) the study does not need to be conducted because the registration substance has a low potential for bioaccumulation based on log Pow below 3.
However, information on the bioaccumulative potential of the source substance Methanol is available (please see below).
Supporting information
For the source substance Methanol experimental BCFs < 10 in fish, including Cyprinus carpio and Leuciscus idus, have been reported by Hansch and Leo (1979), Gluth et al. (1985), Freitag et al. (1985) and Howard (1990). These results are expected because methanol has a high water solubility and a low octanol-water partition coefficient (log Kow = - 0.82 to – 0.64) (Hansch and Leo 1979).
Conclusion
The study does not need to be conducted because the registration substance has a low potential for bioaccumulation based on log Pow <= 3 (study scientifically not necessary). However, based on a read across to the source substance Methanol a BCF <10 was derived.
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.
