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Ecotoxicological information

Toxicity to soil macroorganisms except arthropods

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Reference
Endpoint:
toxicity to soil macroorganisms except arthropods: long-term
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Experimental start date: 5 October 2020
Experimental completion date: 18 December 2020
Unaudited draft report date: 8 January 2021
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 222 (Earthworm Reproduction Test (Eisenia fetida/Eisenia andrei))
GLP compliance:
yes
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch number of test material: GE9061672
- Expiration date of the lot/batch:
- Purity test date:

Analytical monitoring:
no
Test organisms (species):
Eisenia fetida
Animal group:
annelids
Details on test organisms:
TEST ORGANISM
- Common name: redworm, brandling worm, panfish worm, trout worm, tiger worm, red wiggler worm
- Source: BIAS Labs Ltd (Kirkcaldy, UK)
- Age at test initiation (mean and range, SD): between 2 months and 1 year old
- Weight at test initiation (mean and range, SD): between 300 and 600 mg

ACCLIMATION
- Acclimation period: minimum of 24h
- Acclimation conditions (same as test or not): same as test
- Health during acclimation (any mortality observed):
Study type:
laboratory study
Remarks:
Conducted in 1-2L Glass containers, allowing a moist substrate depth of about 5-6cm with 500 to 600g dry mass of substrate
Substrate type:
artificial soil
Remarks:
Composition: - Sphagnum peat: 10% w/w -Kaolin Clay: 20% w/w - Industrial sand (fine): 70% w/w
Limit test:
no
Total exposure duration:
28 d
Post exposure observation period:
The soil removed from the container after 28 days and containing any cocoons will be then returned, then incubated for 4 additional weeks under the same test conditions except that feeding only takes place once at the start of this phase of test.

At the end of the exposure period the number of juveniles hatched from the cocoons and all signs of harm or damage to the worm will be recorded
Test temperature:
20 +/- 2 C
pH:
6.0 +/- 0.5
Moisture:
40 to 60%
Details on test conditions:
TEST SYSTEM
- Test container (material, size): 1-2L glass
- Amount of soil or substrate: 5-6cm with 500 to 600g dry mass of substrate
- No. of organisms per container (treatment): 40 worms per concentration
- No. of replicates per treatment group: 4 groups of 10 worms
- No. of replicates per control: Eight groups of 10 worms
- No. of replicates per vehicle control:

SOURCE AND PROPERTIES OF SUBSTRATE
- Composition (if artificial substrate): Sphagnum peat: 10% w/w ;Kaolin Clay: 20% w/w; Industrial sand (fine): 70% w/w

OTHER TEST CONDITIONS
- Photoperiod: 16h light and 8h dark
- Light intensity: 400 to 800 lux


VEHICLE CONTROL PERFORMED: yes/no

TEST CONCENTRATIONS
- Spacing factor for test concentrations: not exceeding 1.8
- Justification for using less concentrations than requested by guideline:
- Range finding study: NO
- Test concentrations: 16.3, 29.4, 52.9, 95.3, 171.5, 308.6, 555.6, 1000 mg/kg sdw
- Results used to determine the conditions for the definitive study:
Reference substance (positive control):
yes
Remarks:
Boric Acid, recommended in the ISO 11268-2 standard, at a nominal concentration of 600mg/kg/sdw
Remarks on result:
other: Study planned and commissioned. Expected completion and results January 2021.
Details on results:
Study planned and commissioned. Expected completion and results January 2021.

See attached study plan

Executive summary:

4,4-isopropylidenediphenol, ethoxylated (BPA-4EO) (EC 500-082-2) is being assessed for the purpose of the evaluation of the toxicity to soil macroorganisms (except arthropods). The study, according to the OECD TG 222, has been planned and commissioned to the Groupement de Recherches de Lacq, Analytical Department, P.O Box 34, 64170 LACQ - France.


Receipt of the draft study report from the CRO is expected to be on January 2021.


The reason for such a delay in reference to ECHA 30 November 2020 deadline (Refs: TPE-D-2114489554-35-01/F), are explained in a separate letter, attached in background material. 

Description of key information

Indirect exposure of BPA (1 -4.5 EO) to soil cannot be excluded. Therefore, according to column 2 of annex IX of Reach regulation, "in the absence of toxicity data for soil organisms, the equilibrium partitioning method may be applied to assess the hazard to soil organisms". ECHA's guidance on information requirements and chemical safety assessment, chapter R.7c (v4.0 ; June 2017 ; pp.158 -159) explains how EPM should be used. In the absence of any soil toxicity data, a soil hazard category must be assigned to the substance. BPA- (1 -4.5 EO) is not readily biodegradable but not H400/H410. It falls therefore within the scope of soil hazard category 3. In this category, it is demanded to conduct one confirmatory long-term soil testing. It is our understanding that invertebrate testing is preferred to plant testing in a first approach (ECHA's guidance R.7c; v4.0 ; June 2017 ; p. 149, fourth paragraph). Therefore, a study according to OECD 222 guideline is currently ongoing. The study, has been planned and commissioned to the Groupement de Recherches de Lacq, Analytical Department, P.O Box 34, 64170 LACQ - France. Receipt of the draft study report from the CRO is expected to be on January 2021.


The reason for such a delay in reference to ECHA 30 November 2020 deadline (Refs: TPE-D-2114489554-35-01/F), are explained in a separate letter, attached to this dossier. 

Key value for chemical safety assessment

Additional information