Registration Dossier

Ecotoxicological information

Toxicity to soil macroorganisms except arthropods

Currently viewing:

Administrative data

Link to relevant study record(s)

Reference
Endpoint:
toxicity to soil macroorganisms except arthropods: short-term
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH

1. HYPOTHESIS FOR THE ANALOGUE APPROACH
This read-across is based on the hypothesis that source and target substances have similar toxicological properties because
• they are manufactured from similar or identical precursors under similar conditions
• they share structural similarities with common functional groups: quaternary ammonium and saturated or unsaturated alkyl chains with comparable length (corresponding to scenario 2 of the read-across assessment framework)

The read-across hypothesis is based on structural similarity of target and source substances. Based on available experimental data, including key physicochemical properties and data from acute toxicity, irritation, sensitization (human) and genotoxicity studies, the read-across strategy is supported by a quite similar toxicological profile of all substances.

Therefore, read-across from the existing ecotoxicity, environmental fate and toxicity studies conducted with the source substances is considered as an appropriate adaptation to the standard information requirements of the REACH Regulation for the target substance, in accordance with the provisions of Annex XI, 1.5 of the REACH Regulation.

A justification for read-across is attached to IUCLID section 13.

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
See justification for read-across attached to IUCLID section 13.

3. ANALOGUE APPROACH JUSTIFICATION
See justification for read-across attached to IUCLID section 13.

4. DATA MATRIX
See justification for read-across attached to IUCLID section 13.
Reason / purpose:
read-across: supporting information
Reason / purpose:
read-across source
Principles of method if other than guideline:
acute earthworm study
Test organisms (species):
Eisenia fetida
Animal group:
annelids
Study type:
laboratory study
Substrate type:
artificial soil
Limit test:
yes
Duration:
14 d
Dose descriptor:
NOEC
Effect conc.:
1 000 mg/kg soil dw
Basis for effect:
other: mortality, behaviour, body weight

Description of key information

Key value for chemical safety assessment

Short-term EC50 or LC50 for soil macroorganisms:
1 000 mg/kg soil dw

Additional information

No experimental data are available for the target substance Di-C12-18 alkyldimethyl ammonium chloride. However, a short-term toxicity study with Eisenia fetida is available for the closely related source substance DHTDMAC. A justification for read-across is attached to IUCLID section 13.

 

Eisenia fetida was exposed to DHTDMAC (solved in methanol, 76.1% active ingredient) incorporated into artificial soil consisting of 9.4% organic matter, 70% fine sand and 20% kaolinite clay. At the only concentration of the definitive test with 1000 mg active ingredient/kg dry soil no mortality, no significant reduction in body weight nor any behavioural effects were observed after 14 days.