Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Additional information

Toxicity to soil macroorganisms

Key study

In an OECD 207 study conducted under GLP conditions, the 14 -day NOEC and LC50 of Molyvan 855 for earthworms (Eisenia foetida) is > 1000 mg/kg soil dw. (Harlan Laboratories, 2011).

Toxicity to terrestrial arthropods

This endpoint can potentially be used to address REACH Annex IX endpoint 9.4.1. In this instance this REACH endpoint is already addressed through the toxicity to terrestrial macroorganisms study on Earthworms as included in Section 6.3.1 of IUCLID.

Toxicity to terrestrial plants

Although Molyvan 855 falls under Soil Hazard Category 3 (according to ECHA Guidance on CSA document R7c table R.7.11 -2), due to its high estimated adsorption potential (Estimated log10 Koc 3.52 - 5.43 for dominant lauric acid and myristic acid reaction; the less abundant fatty acids are estimated log10 Koc values 2.44 - 6.47 (Harlan Laboratories Limited, 2014)), it must be noted that Molyvan 855 is not very toxic to aquatic organisms (daphniaEC50 (48 h) is 1.5 mg/l (Safepharm Laboratories, 1997)) and is not expected to be persistent in the environment (biodegradation averaged 57% and 61%, based on BOD, and elimination was 98% and 97% based on residual test substance, after 28 days in sludge in two biodegradation studies (Mitsubishi Chemical Medience Corporation, 2009, and Kagakuhin Kensa Kyokai Foundation, 1987, respectively)).

The existing terrestrial data concerning invertebrate and microbial toxicity showed no effects at the limit dose in two studies (the 14-day NOEC to earthworm is greater than 1000 mg/kg wwt (Harlan Laboratories Limited, 2011); the 28-day NOEC for nitrogen transformation activity of soil microorganisms is greater than 1000 mg/kg soil dwt (Harlan Laboratories, 2011)). These endpoints cover the major potential exposure pathways of surface contact, soil particle ingestion and pore-water. The terrestrial plant assay is largely focused on uptake via pore water which is already addressed in the existing studies.

In accordance with ECHA Guidance on CSA document R7c section R.7.11.5.3, based on the existing data,  there is sufficient evidence to allow a robust assessment of the terrestrial ecotoxicology endpoints and no further data are considered necessary, therefore, the toxicity to terrestrial plants study is waived. 

Toxicity to soil microorganisms

Key study

In an OECD 216 study conducted under GLP conditions the EC50 and NOEC of Molyvan 855 is >1000 mg/kg soil dry weight (Harlan Laboratories, 2011).

Toxicity to birds

According to 9.6.1Column 2 of Annex IX of the European Union (EU) Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) 1907/2006 regulation, additional mammalian testing is not justified as the existing mammalian toxicity data (see Section 7) set does not indicate any triggers or concerns that would warrant additional testing, therefore this endpoint is waived.