Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Additional information

The key document selected for deriving the PNECaquatic is the Daphnia magna Reproduction Test (EC10 (21d) = 1.91 mg/L) conducted by BASF (BASF SE, 2013; report no. 51E0721/11E121).

Short-term toxicity to fish:

With high probability acutely not harmful to fish under neutralised test conditions.

The toxicity of 1 -Ethylpiperidine (CAS 766 -09 -6) to the test organism Leuciscus idus was tested closely to the Guideline DIN 38 412, June 1982. The obtained LC50 (96 hr) was 25 mg/L. After neutralisation, no mortality was observed at a concentration of 100 mg/L, therefore it can be assumed that the toxic effect is due to the pH shift induced by the test substance.

Long-term toxicity to fish:

The results from short-term toxicity tests on fish, Daphnia and algae demonstrate that algae are the most sensitive trophic level tested. Therefore, it may be concluded that results from a long-term test in fish would not reveal a greater hazard than already determined by the available data. Therefore, and for reasons of animal welfare, a chronic test on fish is not provided.

In Annex IX of Regulation (EC) No 1907/2006, it is laid down that long-term toxicity to fish shall be proposed by the registrant if the chemical safety assessment indicates the need to investigate further the effects on fish.

According to Annex I of this regulation, the chemical safety assessment triggers further action when the substance or the preparation meets the criteria for classification as dangerous according to Directive 67/548/EEC or Directive 1999/45/EC or is assessed to be a PBT or vPvB.

1 -ethylpiperidine is not a PBT or vPvB substance. The ACR approach according to ECETOC (2003, Report no. 91) results in NOECs greater than 1 mg/L based on the effect data for neutralised test solutions.

Based on the available acute data, the substance is not to be classified as dangerous to the environment and it is not a PBT of vPvB substance. No further information indicate that the substance may be hazardous to the environment. With regard to the results of the ACR approach and for reasons of animal welfare, a long-term study on the toxicity to fish is not provided.

Short-term toxicity to aquatic invertebrates:

The substance is with high probability acutely not harmful to aquatic invertebrates.

The toxicity of 1 -Ethylpiperidine (CAS 766 -09 -6) to the test organism Daphnia magna STRAUS tested according the OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test). The obtained EC50 (48 hr) was >100 mg/L (BASF AG; study no.: 2006/0006/08).

Long-term toxicity to aquatic invertebrates:

To determine chronic effects of 1 -ethylpiperidine (CAS 766 -09 -6) on aquatic invertebrates, a GLP-study according to OECD 211 was performed with Daphnia magna. The test concentrations were analytically verified and were within the range of ±20% of the nominal concentrations). The most sensitive endpoint was reproduction. The EC10 was determined to be 1.83 mg/L (reproduction; nominal; 95% CL: 1.06 - 3.17 mg/L), the NOEC 2.2 mg/L (nominal; reproduction) (BASF SE, 2013; report no. 51E0721/11E121). All validity criteria were fulfilled in this study.

Toxicity to aquatic algae and cyanobacteria:

Acutely harmful to aquatic algae and cyanobacteria.

The toxicity of 1 -Ethylpiperidine (CAS 766 -09 -6) to the test organism Desmodesmus subspicatus was tested according to the OECD Guideline 201 (Alga Growth Inhibition Test). The effect concentrations are [ErC10 (72 hr) = 8.9 mg/L; ErC50 (72 hr) =24.6 mg/L; NOEC (72 hr) = 1.9 mg/L].

Toxicity to microorganisms:

The inhibition of the degradation activity of activated sludge is not anticipate when introduced in appropriately low concentrations.

In three tests performed according to ISO 8192 B, activated sludge (industrial) was exposed to 1 -Ethylpiperidine for 30 minutes and an EC10 of 500 mg/L (BASF AG 1988; 01.0122), an EC20 of>1500 mg/L (BASF AG 1988; 01.0122) and an EC40 of 400 mg/L (BASF AG 1987; 01.0122)was determined.

In addition experimental data from the structurally similar substance 1 -Methylpiperidine (CAS 626 -67 -5) were used to support the assessment.

Two tests were performed according to the OECD Guideline 209 (Activated sludge, Respiration Inhibition Test), activated sludge (domestic) was exposed for 30 minutes and an EC20 of>996 mg/L (BASF AG 1989; 01.89/1260) and an EC20 of >1000 mg/L (BASF AG 101.91/0271/08/1) was obtained.