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Ecotoxicological information

Toxicity to terrestrial plants

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Endpoint:
toxicity to terrestrial plants: short-term
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Only short abstract available
Qualifier:
according to guideline
Guideline:
OECD Guideline 208 (Terrestrial Plants Test: Seedling Emergence and Seedling Growth Test)
Qualifier:
equivalent or similar to guideline
Guideline:
other: EEC Directive 79/831 "Higher Plant Growth Test"
GLP compliance:
not specified
Analytical monitoring:
no
Vehicle:
no
Species:
Avena sativa
Plant group:
Monocotyledonae (monocots)
Details on test organisms:
- Common name: oat
Species:
Lycopersicon esculentum
Plant group:
Dicotyledonae (dicots)
Details on test organisms:
- Common name: tomato
Species:
Raphanus sativus
Plant group:
Dicotyledonae (dicots)
Details on test organisms:
- Common name: radish
Test type:
early seedling growth toxicity test
Study type:
other: not reported
Substrate type:
not specified
Limit test:
no
Total exposure duration:
2 wk
Remarks:
The test was finished at least two weeks after five of the control seedlings have emerged.
Key result
Species:
Avena sativa
Duration:
2 wk
Dose descriptor:
NOEC
Effect conc.:
1 000 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
growth
Key result
Species:
Lycopersicon esculentum
Duration:
2 wk
Dose descriptor:
NOEC
Effect conc.:
300 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
growth
Key result
Species:
Lycopersicon esculentum
Duration:
2 wk
Dose descriptor:
LOEC
Effect conc.:
1 000 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
growth
Key result
Species:
Raphanus sativus
Duration:
2 wk
Dose descriptor:
NOEC
Effect conc.:
300 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
growth
Key result
Species:
Raphanus sativus
Duration:
2 wk
Dose descriptor:
LOEC
Effect conc.:
1 000 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
growth

The test was finished 2 weeks after five of the control seedlings have emerged in the control. Lycopersicon esculentum and Raphanus sativus were more sensitive with a NOEC of 300 mg/kg soil dw compared to Avena sativa with a NOEC of 1000 mg/kg soil dw.

Endpoint:
toxicity to terrestrial plants: long-term
Data waiving:
other justification
Justification for data waiving:
other:

Description of key information

No studies on long-term terrestrial toxicity are available for this substance.The substance is predicted to be biodegradable therefore, no chronic exposure of terrestrial organisms is expected. A terrestrial plant toxicity test (short-term, OECD 208, Klimisch 4) with the read-across substance, CAS-No. 68002-79-9, is available, indicating no toxicity (NOEC = 300-1000 mg/kg soil dw, LOECs = 1000 mg/kg soil dw).

.

As discussed in ECHA Decision number CCH-D-2114343360-61-01/F, ECHA notes that additional toxicity testing on fish and aquatic invertebrates is being requested as part of the present Decision and the results of these tests may subsequently allow the derivation of PNECwater. If the results allow the subsequent derivation of a PNECwater, the Registrant may consider the ITS as recommended in section R.7.11.6., Chapter R.7c of the ECHA Guidance on information requirements and chemical safety assessment (May 2008), and determine the need for further testing on terrestrial organisms. In this case it may be possible to waive the corresponding terrestrial toxicity tests by including a justified argument for adaptation of Annex IX, 9.4.3. and Annex X, 9.4.6. or of Annex IX, 9.4.1. and Annex X, 9.4.4. in the registration dossier.

As discussed above, the Daphnia study is still in progress due to significant analytical issues. Once the study is completed, then the ITS will be evaluated, and determined if these studies are actually required. On the basis of existing study data, the substance is considered to be non-toxic and biodegradable.  Structural analogues do not show toxicity, nor does existing study data on soil micro-organisms.  The registrant considers that it is highly likely that the ITS will demonstrate this fact.  Therefore a decision on whether to conduct these tests or not will be taken once the ITS investigation can be completed.

Key value for chemical safety assessment

Additional information

No studies on long-term terrestrial toxicity are available for this substance. The substance is predicted to be biodegradable therefore, no chronic exposure of terrestrial organisms is expected. Furthermore, a terrestrial plant toxicity test (short-term, OECD 208) with the read-across substance, CAS-No. 68002-79-9, is available, indicating no toxicity (NOEC = 300-1000 mg/kg soil dw, LOECs = 1000 mg/kg soil dw). In addition, fatty acid esters are readily metabolised to fatty acids and alcohols; these components naturally occur in sediment and soils, are part of physiological pathways and can be used as energy source.

A report justifying the read-across approach is included in IUCLID Chapter 13.