Benzyldimethylamine

Long-term toxicity to fish

Administrative data

Endpoint:

fish early-life stage toxicity

Type of information:

experimental study planned

Justification for type of information:

TESTING PROPOSAL ON VERTEBRATE ANIMALS
Long-term toxicity testing on fish is an information requirement under Annex IX to REACH (Section 9.1.6.). Therefore, information on long-term toxicity on fish must be provided to assess the aquatic toxicity of this substance. Hence, a testing proposal is included in the present dossier to conduct a Fish Early-Life Stage Toxicity test, according to OECD Test Guideline 210.

NON-CONFIDENTIAL NAME OF SUBSTANCE:
- Name of the substance on which testing is proposed to be carried out: N,N-Dimethylbenzylamine (CAS 103-83-3)
- Name of the substance for which the testing proposal will be used [if different from tested substance]

CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION :
- Available GLP studies: no data available
- Available non-GLP studies: no data available
- Historical human/control data: not applicable
- (Q)SAR: HA-QSAR predictions using iSafeRat QSAR models cannot be provided for this substance at the time being. Therefore, performing new experimental test on N,N-Dimethylbenzylamine is needed to fulfil chronic fish endpoint.
- In vitro methods: not applicable
- Weight of evidence: no data available
- Grouping and read-across: not applicable
- Substance-tailored exposure driven testing: not applicable
- Approaches in addition to above: not applicable
- Other reasons: 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:
not applicable

FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- Details on study design / methodology proposed
The proposed Fish, Early-Life Stage Toxicity Test (test method: OECD TG 210) is appropriate to cover the information requirement for long-term toxicity on fish (ECHA Guidance R.7.8.4.1.). The substance is water soluble (8 g/L at 20°C) and has a low adsorptive property (log Kow of 1.98). If the testing proposal is accepted, we will monitor the test concentration(s) of the substance throughout the exposure duration and report the results.
If it is not possible to demonstrate the stability of exposure concentrations (i.e. measured concentration(s) not within 80-120% of the nominal concentration(s)), we will express the effect concentration based on measured values as described in OECD TG 210. In case a dose- response relationship cannot be established (no observed effects), we will demonstrate that the approach used to prepare test solutions was adequate to maximise the concentration of the substance in the test solutions.

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 210 (Fish, Early-Life Stage Toxicity Test)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Benzyldimethylamine

EC Number:

203-149-1

EC Name:

Benzyldimethylamine

Cas Number:

103-83-3

Molecular formula:

C9H13N

IUPAC Name:

benzyldimethylamine

Details on test material:

To be confirmed (testing proposal)