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Ecotoxicological information

Toxicity to terrestrial arthropods

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Administrative data

Endpoint:
toxicity to bees: acute oral
Data waiving:
other justification
Justification for data waiving:
other:
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING

On the 27th July 2017, ECHA sent a final decision on a complaint check.

DETAILS:
Decision number: CCH-D-2114366662-44-01/F
Substance name: benzyl 3-(isobutyryloxy)-1-isopropyl-2,2-dimethylpropyl phthalate
EC number: 701-008-3
CAS number: 16883-83-3
Registration number: 01-2119519236-42-0000
Submission number: MT588728-89
Submission date: 03.12.2015
Registered tonnage band: 1000+T


The final letter includes the following tests (environment and ecotox sections):

1. Ready biodegradability (Annex VII, Section 9.2.1.1.; test method: CO2
evolution test, OECD TG 301B) or Ready biodegradability (Annex VII, Section 9.2.1.1.; test method: MITI test (I), OECD TG 301C) or Ready biodegradability (Annex VII, Section 9.2.1.1.; test method: Closed bottle test, OECD TG 301D) or Ready biodegradability (Annex VII, Section 9.2.1.1.; test method: Manometric respirometry test, OECD TG 301F) or Ready biodegradability (Annex VII, Section 9.2.1.1.; test method: Ready biodegradability – CO2 in sealed vessels (headspace test), OECD TG 310) with the registered substance;

2. Long-term toxicity testing on aquatic invertebrates (Annex IX, Section 9.1.5.; test method: Daphnia magna reproduction test, EU C.20./OECD TG 211) with the registered substance;

3. Long-term toxicity testing on fish (Annex IX, Section 9.1.6.1.; test method: Fish, early-life stage (FELS) toxicity test, OECD TG 210) with the registered substance; 9. Simulation testing on ultimate degradation in surface water (Annex IX, Section 9.2.1.2.; test method: Aerobic mineralisation in surface water – simulation biodegradation test, EU C.25./OECD TG 309) at a temperature of 12 °C with the registered substance. The biodegradation of each relevant constituent present in concentration at or above 0.1% (w/w) or, if not technically feasible, in concentrations as low as technically detectable shall be assessed;

4. Soil simulation testing (Annex IX, Section 9.2.1.3.; test method: Aerobic and anaerobic transformation in soil, EU C.23./OECD TG 307) at a temperature of 12 °C with the registered substance. The biodegradation of each relevant constituent present in concentration at or above 0.1% (w/w) or, if not technically feasible, in concentrations as low as technically
detectable shall be assessed;

5. Sediment simulation testing (Annex IX, Section 9.2.1.4.; test method: Aerobic and anaerobic transformation in aquatic sediment systems, EU C.24./OECD TG 308) at a temperature of 12 °C with the registered substance. The biodegradation of each relevant constituent present in concentration at or above 0.1% (w/w) or, if not technically feasible, in concentrations as low as technically detectable shall be assessed;

6. Long-term toxicity to terrestrial invertebrates (Annex X, Section 9.4.4.; test method: Earthworm reproduction test (Eisenia fetida/Eisenia andrei) OECD 222 or Enchytraeid reproduction test OECD 220) with the registered substance;

7. Long-term toxicity testing on plants (Annex X, Section 9.4.6.; test method: Terrestrial plants, growth test, OECD 208, with at least six species tested (with as a minimum two monocotyledonous species and four dicotyledonous species) or test method: Soil Quality – Biological Methods –
Chronic toxicity in higher plants, ISO 22030) with the registered substance; and

8. Effects on soil micro-organisms (Annex IX, Section 9.4.2.; test method: Soil microorganisms: nitro

FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- Materials and methods are not yet available.

Further justification and investigation will be provided when the final results on the other endpoints will be available.


Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion