Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Short-term toxicity to fish

LL50 (96 h) > 100 mg/L

Long-term toxicity to fish

NOEC based on assessment > 1 mg/l

Short-term toxicity to aquatic invertebrates

EC50 (48h) = 4.1 mg/l based on mean measured concentrations

Long-term toxicity to aquatic invertebrates

NOEC based on reproductive output is = 1 mg/l

Toxicity to aquatic algae and cyanobacteria

ErL50 = 20 mg/L loading rate WAF

Additional information

Short-term toxicity to fish

This endpoint was addressed using a read across approach to structural analogues of the registered substance. The two analogues chosen for this endpoint are Tall oil and Diethanolamine (DEA). The justification of choosing these two analogues is provided in detail in the document "Tall oil compound with diethanolamine -- read across justification based on the Read-Across Assessment Framework (RAAF) document", attached in section 13 of this dossier. Two key studies are provided, one on tall oil and one on diethanolamine. In this respect it is considered that the data submitted provides an adequate reflection of the properties of the registered substance. 

A limit test was carried out to assess the acute toxicity potential of the read across substance distilled tall oil toDanio rerioin accordance with the standardised guideline OECD 203 under GLP conditions. The study was assigned a reliability score of 2 in accordance with the criteria of Klimisch (1997).

The fish were exposed to a 100 mg/L loading rate WAF of the test material for 96 hours under semi-static conditions. Fish were observed for any effects on mortality and additionally for any sub-lethal and behavioural effects.

No mortality was seen throughout the test period, nor were any sub-lethal effects noted.

Under the conditions of this study, the 96 hour LL50 was determined to be > 100 mg/L and the NOELR to be 100 mg/L based on exposure to a WAF of the test material. No classification of the test material is required in accordance with EU criteria. 

The second key study investigates the acute toxicity potential of the read across substance diethanolamine to Pimephales promelas in accordance with the standardised guideline ASTM-Standard E 729-80 under GLP conditions. The study was assigned a reliability score of 2 in accordance with the criteria of Klimisch (1997).

Fry, juveniles and subadults were exposed to the test material for 96 hours under static conditions.

Under the conditions of this study, the 96 hour LC50 of the test material to fathead minnows was determined to be 1460 mg/L. The test material requires no classification in accordance with EU criteria.

Under the conditions of these studies, neither the tall oil nor diethanolamine component of the test material requires classification for acute toxicity. On this basis, and as a precautionary measure, the overall determination that will be carried forward for risk assessment of the registered substance will be the 96 hour LL50 of > 100 mg/L and NOELR of 100 mg/L based on exposure to a WAF of the test material.

Long-term toxicity to fish

An evaluation on the long-term toxicity to fish was performed. The NOEC value estimated is > 1 mg/l.

Short-term toxicity to aquatic invertebrates

The acute toxicity potential of the test material to Daphnia magna was assessed in the key study in accordance with the standardised guidelines OECD 202 and EU Method C.2 under GLP conditions. It was assigned a reliability score of 1 in accordance with the criteria set forth in Klimisch (1997).

Due to the low aqueous solubility and complex nature of the test material, it was prepared as a Water Accommodated Fraction (WAF).

Following preliminary range-finding tests, twenty daphnids (4 replicates of 5 animals) were exposed to WAFs of the test material over a range of nominal loading rates of 1.0, 1.8, 3.2, 5.6 and 10 mg/L for 48 hours at a temperature of approximately 21 °C under static test conditions. The number of immobilisedDaphniaand any adverse reactions to exposure were recorded after 24 and 48 hours.

Chemical analysis was conducted on the loading rate at the No Observed Effect Concentration (NOEC) and above. Analysis of the 3.2, 5.6 and 10 mg/L loading rate WAFs at 0 and 48 hours gave measured concentrations of near nominal.

Under the conditions of this study, exposure of Daphnia magna to the test material gave a 48 hour EC50 value based on mean measured concentrations of 4.1 mg/L; 95 % confidence limits 3.1 - 5.5 mg/L.

As a result of the EC50 value the test material does not require a classification for Acute Aquatic Toxicity in accordance with EU criteria.

Long-term toxicity to aquatic invertebrates

The chronic toxicity of the test item Tall oil, compound with diethanolamine to the water fleaDaphnia magnawas investigated in a reproduction test according to OECD guideline 211 under semi-static exposure conditions over a period of 21 days.

The test item is a poorly soluble UVCB substance. The test solutions consisted of Water Accomodated Fractions (WAFs) prepared separately for each test concentration by weighing the respective amount of test item in test water, stirring the resulting suspension for about 3 hours at room temperature in the dark and filtering it with glass fiber filter. The test media were replaced three times per week: each Monday, Wednesday and Friday of the test the test solutions were freshly prepared.

The loading rates tested were100, 31.6, 10, 3.16 and 1.00 mg/l.

Ten individual daphnids were exposed to each test concentration. A control was tested in parallel.

The test concentrations were determined by means of dissolved organic carbon (DOC) analysisat days 0, 9 and 19. These analyses confirmed the very limited solubility of the test item. The assessment of the toxicity was based on the loading rates of the test item.

A significant dose-dependent mortality was observed: at the loading rate of 100 mg/l, 9 out of 10 parental daphnids died, and at 31.6 mg/l 6 parental daphnids died over the course of the test. At all lower loading rates 10.0. 3.16 and 1.00 mg/l and in the control, no mortality was observed.

The time needed for each parental animal to produce the first living offspringwas on average 8.8, 7.7, 7.5, 11.0, 8.0 and 7.9 days in the100, 31.6, 10, 3.16 and 1.00mg/l loading rates and the control, respectively.

With respect to the endpoint reproductive output, the following effects compared to the control were observed: 76.9% at 100 mg/l loading rate, 44.2% at 31.6 mg/l, 7.9% at 10.0 mg/l and 8.4 % at 3.16 mg/l. No significant effects were observed at 1.00 mg/l.

With respect to the endpoint intrinsic rate of population increase, the following effects compared to the control were observed: 68.6% at 100 mg/l loading rate and 36.8% at 31.6 mg/l. No significant effects were observed at 10.0, 3.16 and 1.00 mg/l.

The results of the inhibition on the reproductive output as well as on the intrinsic rate of population increase of the test item onDaphnia magnaare summarized in the following table based on the loading rates:

Parameter (0-21 d)

Reproductive output

[mg/l]

Intrinsic rate of population increase [mg/l]

EC10

8.30

12.7

LOEC

3.16

31.6

NOEC

1.00

10.0

All validity criteria were fulfilled.

Based on the NOEC value, calculated for the reproductive output in the long-term toxicity study onDaphnia Magna, the test substance should be classified as Category Chronic 3 for the aquatic environment.

Toxicity to aquatic algae and cyanobacteria

The key study was conducted in line with GLP and the standardised guidelines OECD 201and EU Method C.3 and assessed the effect of the test material on the growth of the green alga Pseudokirchneriella subcapitata.

Due to the low aqueous solubility and complex nature of the test material, it was prepared as a Water Accommodated Fraction (WAF).

Following preliminary range-finding tests, the algal cells were exposed to WAFs of the test material over a range of nominal loading rates of 1.0, 3.2, 10, 32 and 100 mg/L (three replicate flasks per concentration) for 72 hours, under constant illumination and shaking at a temperature of 24 ± 1 °C.

Samples of the algal populations were removed daily and cell concentrations determined for each control and treatment group.

Under the conditions of this study, the EL50 for growth was determined to be 20 mg/L loading rate WAF (95 % confidence limits 10 - 32 mg/L loading rate WAF), with the NOELR and LOELR being 10 and 32 mg/L, respectively.

Analysis of the test preparations at 0 hours showed measured test concentrations to range from 0.91 mg/L at 1.0 mg/L loading rate WAF through to 98 mg/L at 100 mg/L loading rate WAF whilst concentrations in the range of 0.92 mg/L at 1.0 mg/L loading rate WAF through to 72 mg/L at 100 mg/L loading rate WAF were obtained at 72 hours.

Given that the toxicity cannot be attributed to a single component or a mixture of components but to the test item as a whole the results were based on nominal loading rates only.

Justification for classification or non-classification

According to the CLP Regulation (EC n. 1272/2008), Part 4: Environmental Hazards, the substances can be classified for hazardous to the aquatic environment (fish toxicity) when the following criteria are met:

A )Acute (short-term) aquatic hazard

Category Acute 1:

96 hr LC 50 (for fish) ≤ 1 mg/l and/or, 48 hr EC 50 (for crustacea) ≤ 1 mg/l and/or, 72 or 96 hr ErC 50 (for algae or other aquatic plants) ≤ 1 mg/l.

B) Long-term aquatic hazard

(ii) Rapidly degradable substances (Note 3) for which there are adequate chronic toxicity data available

Category Chronic 1: (Note 1)

Chronic NOEC or EC x (for fish) ≤ 0,01 mg/l and/or

Chronic NOEC or EC x (for crustacea) ≤ 0,01 mg/l and/or

Chronic NOEC or EC x (for algae or other aquatic plants) ≤ 0,01 mg/l.

Category Chronic 2:

Chronic NOEC or EC x (for fish) > 0,01 to ≤ 0,1 mg/l and/or

Chronic NOEC or EC x (for crustacea) > 0,01 to ≤ 0,1 mg/l and/or

Chronic NOEC or EC x (for algae or other aquatic plants) > 0,01 to ≤ 0,1 mg/l.

Category Chronic 3:

Chronic NOEC or EC x (for fish) > 0,1 to ≤ 1 mg/l and/or

Chronic NOEC or EC x (for crustacea) > 0,1 to ≤ 1 mg/l and/or

Chronic NOEC or EC x (for algae or other aquatic plants) > 0,1 to ≤ 1 mg/l.

 

Based on the long-term toxicity study on Daphnia Magna, the test substance is classified for Aquatic Chronic 3.