Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
bioaccumulation in aquatic species: fish
Type of information:
experimental study planned
Study period:
As soon as testing proposal is agreed upon by ECHA
Justification for type of information:
TESTING PROPOSAL ON VERTEBRATE ANIMALS
In order to come to an unequivocal conclusion on the PBT properties of the substance, further information is needed. The BCF study is proposed to generate the necessary information to come to an unequivocal conclusion. See section 2.3 PBT assessment for further details.

NON-CONFIDENTIAL NAME OF SUBSTANCE:
- Name of the substance on which testing is proposed to be carried out : 4,4'-methylenebis-N-sec-butylaniline (MDBA)

CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION
- Available GLP studies : none available for the registered substance. A Japanese study with the starting material 4,4'-methylenedianiline (MDA, CAS 101-77-9) is available in the disseminated dossier on the ECHA website. This study shows that MDA is not bioaccumulative (BCF values ranging from <3.1 to 15; well below the trigger value of 2000 L/kg). The general adaptation possibilities (e.g. read-across) are not applicable, due to the large difference in Log Kow between MDA and MDBA.
- Available non-GLP studies: none available
- Historical human data: none available
- (Q)SAR: a (Q)SAR model for BCF is available but results from this (Q)SAR model cannot be used as stand-alone results for definitive conclusions in the PBT assessment . The estimated value for BCF based on EpiSuite is 1698 L/kg, indicating that the substance is possibly not bioaccumulative.
- In vitro methods : none available
- Weight of evidence: not applicable
- Grouping and read-across : not applicable

CONSIDERATIONS THAT THE SPECIFIC ADAPTATION POSSIBILITIES OF ANNEXES VI TO X (AND COLUMN 2 THEREOF) OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
- The substance does not have a low potential for bioaccumulation, since the log Kow is > 3, and direct and indirect exposure of the aquatic compartement is possible.

FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- Details on study design / methodology proposed: The study will be performed according to OECD Guideline 305 (Bioaccumulation in Fish) and according to GLP principles. A definitive choice for 305-I (aqueous exposure) or 305-III (dietary exposure) will be made prior to start of the study.

Data source

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 305 (Bioaccumulation in Fish: Aqueous and Dietary Exposure) -I: Aqueous Exposure Bioconcentration Fish Test
Version / remarks:
Definitive choice for 305-I or 305-II shall be made prior to starting
Qualifier:
according to guideline
Guideline:
OECD Guideline 305 (Bioaccumulation in Fish: Aqueous and Dietary Exposure) -III: Dietary Exposure Bioaccumulation Fish Test
Version / remarks:
Definitive choice for 305-I or 305-II shall be made prior to starting

Test material

Constituent 1
Chemical structure
Reference substance name:
4,4'-methylenebis[N-sec-butylaniline]
EC Number:
226-122-6
EC Name:
4,4'-methylenebis[N-sec-butylaniline]
Cas Number:
5285-60-9
Molecular formula:
C21H30N2
IUPAC Name:
4,4'-methylenebis[N-sec-butylaniline]
Test material form:
liquid
Details on test material:
Appearance: Slight yellow liquid
Storage conditions: At room temperature protected from light

Results and discussion

Applicant's summary and conclusion

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