Santicizer 278®

Toxicity to terrestrial arthropods

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.