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Diss Factsheets

Ecotoxicological information

Toxicity to soil macroorganisms except arthropods

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Administrative data

Link to relevant study record(s)

Reference
Endpoint:
toxicity to soil macroorganisms except arthropods: long-term
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 “assessment report”.
Reason / purpose for cross-reference:
assessment report
Reason / purpose for cross-reference:
read-across source
Key result
Duration:
56 d
Dose descriptor:
EC10
Effect conc.:
176.1 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
reproduction
Remarks on result:
other:
Remarks:
95% CL: 151.0 – 202.3
Duration:
56 d
Dose descriptor:
EC50
Effect conc.:
441.9 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
reproduction
Remarks on result:
other:
Remarks:
95% CL: 414.3 – 475.3
Duration:
56 d
Dose descriptor:
NOEC
Effect conc.:
125 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
reproduction
Duration:
56 d
Dose descriptor:
LOEC
Effect conc.:
250 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
reproduction
Duration:
28 d
Dose descriptor:
NOEC
Effect conc.:
250 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks:
of adults
Duration:
28 d
Dose descriptor:
LOEC
Effect conc.:
500 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks:
of adults
Duration:
28 d
Dose descriptor:
NOEC
Effect conc.:
>= 1 000 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: adult biomass development
Details on results:
Due to the identical molecular weight of source and target substance, the effect concentrations for the source substance are also valid for the target substance without further adjustment.
Validity criteria fulfilled:
yes
Remarks:
Mortality of the adult test animals in the control: 7.5% (required: <=10%) Mean number of juveniles per replicate in the control (+/- SD): 274.1 ± 63.1 (required: = 30) The CV for the number of juveniles in the control: 23.0% (required: = 30%)
Conclusions:
In an Earthworm reproduction test (according to OECD 222, compliant to GLP; 2017) with the source substance 1,6-hexane diamine (HMD; CAS No. 124-09-4) the following results were obtained:
NOEC (28 d, mortality) = 250 mg test item/kg soil (dw)
LOEC (28d, mortality) = 500 mg test item/kg soil (dw).

NOEC (28 d, biomass) = 1000 mg test item/kg soil (dw) (the highest concentration tested).
LOEC (28 d, biomass) > 1000 mg test item/kg soil (dw).

NOEC (56 d, reproduction) = 125 mg test item/kg soil (dw)
LOEC (56 d, reproduction) = 250 mg test item/kg soil (dw).

EC10 (56 d, reproduction) = 176.1 mg test item/kg soil (dw) (95% Confidence limits (CL) = 151.0 – 202.3 mg test item/kg soil (dw)).
EC50 (56 d, reproduction) = 441.9 mg test item/kg soil (dw) (95% CL = 414.3 – 475.3 mg test item/kg soil (dw)).
Because of the identical molecular weight, these results are directly applicable to the target substance MPMD.
Executive summary:

The study used as source investigated the terrestrial toxicity after long-term exposure towards earthworms according to OECD TG 209 (2010). 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

In an Earthworm reproduction test (according to OECD 222, compliant to GLP; 2017) with the source substance 1,6-hexane diamine (HMD; CAS No. 124-09-4) the following results were obtained:


NOEC (28 d, adult mortality) = 250 mg test item/kg soil (dw)


LOEC (28d, adult mortality) = 500 mg test item/kg soil (dw).


 


NOEC (28 d, biomass) ≥ 1000 mg test item/kg soil (dw) (the highest concentration tested).


LOEC (28 d, biomass) > 1000 mg test item/kg soil (dw).


 


NOEC (56 d, reproduction) = 125 mg test item/kg soil (dw)


LOEC (56 d, reproduction) = 250 mg test item/kg soil (dw).


 


EC10 (56 d, reproduction) = 176.1 mg test item/kg soil (dw) (95% Confidence limits (CL) = 151.0 – 202.3 mg test item/kg soil (dw)).


EC50 (56 d, reproduction) = 441.9 mg test item/kg soil (dw) (95% CL = 414.3 – 475.3 mg test item/kg soil (dw)).


 


Because of the identical molecular weight, these results are directly applicable to the target substance MPMD.

Key value for chemical safety assessment

Long-term EC10, LC10 or NOEC for soil macroorganisms:
176.1 mg/kg soil dw

Additional information

The study used as source investigated the terrestrial toxicity after long-term exposure towards earthworms, according to OECD TG 209 (2010). 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.