7-azatridecane-1,13-diamine

Short-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Justification for type of information:

For details on endpoint specific justification please see read-across report in section 13 or find a link in cross-reference “read-across: supporting information”.

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

assessment report

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

9.1 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Remarks:

active ingredient BHT (53.5% in test material)

Basis for effect:

mobility

Remarks on result:

other: 95% CL: 5.9-16 mg BHT/L

Validity criteria fulfilled:

yes

Conclusions:

In a reliable acute immobilization test on Daphnia magna performed compliant to GLP and according to OECD 202 and EU-method C.2 (RL category 1) the following nominal (no)effect concentrations were determined for the test item BHT amine and the active ingredient BHT:
EC50 (48 h): 17 mg test item/L (9.1 mg BHT/L), 95% CL 11 - 29 mg BHT amine/L (5.9 and 16 mg BHT/L)
EC10 / NOEC (48 h): 10 mg test item/L (5.4 mg BHT/L)
EC100 (48 h): 46 mg test item/L (25 mg BHT/L).

Executive summary:

The acute toxicity of the test item BHT amine to Daphnia magna was determined in a 48 hour static test according to the EU Commission Directive 92/69/EEC, Part C.2 and the OECD Guideline for Testing of Chemicals, No. 202 (2004). The nominal test item concentrations tested were 1.0, 2.2, 4.6, 10, 22 and 46 mg BHT amine/L (corresponding to the active ingredient 0.54, 1.2, 2.5, 5.4, 12 and 25 mg BHT/L). Additionally, a control group was tested in parallel. The measured concentrations of BHT amine (based on the active ingredient BHT) in the test media of the test concentrations of 10 to 46 mg/L were between 87 and 95% of the nominal values at the start of the test and between 90 and 95% at the end of the test. Thus, the correct dosing of the test item BHT amine was confirmed. The active ingredient BHT was stable in the test media over the test period of 48 hours. The other active ingredient HMD was not analyzed, since it was found to be stable in the pre-experiment. The biological results were related to the nominal concentrations of the test item and expressed in BHT and the corresponding test item concentrations:

EC50 (48 h): 17 mg test item/L (9.1 mg BHT/L), 95% CL: 11 - 29 mg BHT amine/L (5.9 and 16 mg BHT/L)

EC0 / NOEC (48 h): 10 mg test item/L (5.4 mg BHT/L)

EC100 (48 h): 46 mg test item/L (25 mg BHT/L).

The study used as source investigated Reaction mass of 7-azatridecane-1,13-diamine and hexamethylenediamine (EC 907 -605 -7, which contains relevant amounts of the submission substance,

7-azatridecane-1,13-diamine).The study results of the source compound were considered applicable to the target compound. Justification and applicability of the read-across approach (structural analogue) is outlined in the read-across report in section 13 or find a link in cross reference “assessment report”.

Description of key information

The acute toxicity of the test item "BHT amine" to Daphnia magna was determined in a 48 hour static test according to the EU Commission Directive 92/69/EEC, Part C.2 and the OECD Guideline for Testing of Chemicals, No. 202 (2004). The nominal test item concentrations tested were 1.0, 2.2, 4.6, 10, 22 and 46 mg BHT amine/L (corresponding to the active ingredient 0.54, 1.2, 2.5, 5.4, 12 and 25 mg BHT/L). Additionally, a control group was tested in parallel. The measured concentrations of BHT in the test media of the test concentrations of 10 to 46 mg/L were between 87 and 95% of the nominal values at the start of the test and between 90 and 95% at the end of the test. Thus, the correct dosing of the test item BHT amine was confirmed. The active ingredient BHT was stable in the test media over the test period of 48 hours. The other active ingredient HMD was not analyzed, since it was found to be stable in the pre-experiment. The biological results were related to the nominal concentrations of the test item and expressed in BHT and the corresponding test item concentrations:

EC50 (48 h): 17 mg test item/L (9.1 mg BHT/L), 95% CL: 11 - 29 mg BHT amine/L (5.9 and 16 mg BHT/L)

EC0 / NOEC (48 h): 10 mg test item/L (5.4 mg BHT/L)

EC100 (48 h): 46 mg test item/L (25 mg BHT/L).

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

9.1 mg/L