Registration Dossier
Registration Dossier
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EC number: 202-940-9 | CAS number: 101-41-7
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data is from HSDB and Pubchem authoritative database
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- Environmental bioconcentration factor of the test chemical in fish was estimated using a logKow and a regression-derived equation.
- GLP compliance:
- not specified
- Radiolabelling:
- not specified
- Vehicle:
- not specified
- Test organisms (species):
- other: fish
- Route of exposure:
- aqueous
- Test type:
- not specified
- Water / sediment media type:
- natural water: freshwater
- Reference substance (positive control):
- not specified
- Details on estimation of bioconcentration:
- BASIS FOR CALCULATION OF BCF
- Result based on calculated logKow of: 1.83 - Key result
- Type:
- BCF
- Value:
- 7.5 dimensionless
- Basis:
- whole body w.w.
- Calculation basis:
- other: BCF value of test chemical was estimated using a logKow and a regression-derived equation.
- Remarks on result:
- other: Other details not known
- Validity criteria fulfilled:
- not specified
- Conclusions:
- The estimated BCF (bioaccumulation factor) of test chemical was determined to be 7.5 dimensionless.
- Executive summary:
The bioaccumulation study in fish was conducted for estimating the BCF (bioaccumulation factor) value of test chemical. The bioaccumulation factor (BCF) value was calculated using a logKow of 1.83 and a regression-derived equation. The estimated BCF (bioaccumulation factor) value of test chemical in fish was determined to be 7.5 dimensionless, which does not exceed the bioconcentration threshold of 2000, indicating that the test chemical is considered to be non-accumulative in aquatic organisms.
Reference
According to a classification scheme, the BCF value of test chemical suggests the potential for bioconcentration in aquatic organisms is low.
Description of key information
The bioaccumulation study in fish was conducted for estimating the BCF (bioaccumulation factor) value of test chemical (authoritative databases, 2017). The bioaccumulation factor (BCF) value was calculated using a logKow of 1.83 and a regression-derived equation. The estimated BCF (bioaccumulation factor) value of test chemical in fish was determined to be 7.5 dimensionless, which does not exceed the bioconcentration threshold of 2000, indicating that the test chemical is considered to be non-accumulative in aquatic organisms.
Key value for chemical safety assessment
- BCF (aquatic species):
- 7.5 dimensionless
Additional information
Experimental study and various predicted data of the test chemical were reviewed for the bioaccumulation end point which are summarized as below:
In an experimental key study from authoritative database (2017),bioaccumulation experiment in fish was conducted for estimating the BCF (bioaccumulation factor) value of test chemical. The bioaccumulation factor (BCF) value was calculated using a logKow of 1.83 and a regression-derived equation. The estimated BCF (bioaccumulation factor) value of test chemical in fish was determined to be 7.5 dimensionless.
In a prediction done using the BCFBAF Program of Estimation Programs Interface was used to predict the bioconcentration factor (BCF) of test chemical. The bioconcentration factor (BCF) of test chemical was estimated to be 7.489 L/kg whole body w.w (at 25 deg C).
In an another prediction done by using Bio-concentration Factor module (ACD (Advanced Chemistry Development)/I-Lab predictive module, 2017)), Bio-concentration Factor of the test chemical was estimated to be 18.4 at pH range 1-14, respectively.
On the basis of above results for test chemical(from authoritative and modelling databases,2017), it can be concluded that the BCF value of test chemical ranges from 7.489 to 18.4, respectively,which does not exceed the bioconcentration threshold of 2000, indicating that the test chemical is not expected to bioaccumulate in the food chain.
Waiver statement
In accordance with column 2 of Annex IX of the REACH regulation,testing for this endpointis scientifically not necessary and does not need to be conducted since the test chemicalhas a low potential for bioaccumulation based on logKow ≤ 3.
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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