Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Additional information

There are no data available investigating the aquatic toxicity of Fatty acids, tall-oil, triesters with trimethylolpropane (CAS 94581-09-6). In order to fulfil the standard information requirements, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006, read-across from structurally related substances was conducted.

In accordance with Article 13 (1) of Regulation (EC) No 1907/2006, "information on intrinsic properties of substances may be generated by means other than tests, provided that the conditions set out in Annex XI are met.” In particular for aquatic toxicity, information shall be generated whenever possible by means other than vertebrate animal tests, which includes the use of information from structurally related substances (grouping or read-across).

Having regard to the general rules for grouping of substances and read-across approach laid down in Annex XI, Item 1.5, of Regulation (EC) No 1907/2006 whereby substances may be predicted as similar provided that their physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity.

 

Ecotoxicological parameters for the aquatic toxicity of the target and the source substance are provided in the following table.

ID

CAS

Short term toxicity to fish

Long term toxicity to fish

Short term toxicity to aquatic invertebrates

Long term toxicity to aquatic invertebrates

Toxicity to aquatic algae

Toxicity to microorganisms

Target

94581-09-6

RA: CAS 68002-78-8

RA: CAS 68541-50-4

RA: CAS 403507-18-6

RA: former CAS 85005-23-8

Data Waiving

RA: CAS 68002-78-8

RA: CAS 68002-79-9

RA: CAS 68541-50-4

RA: CAS 403507-18-6

RA: CAS 68002-78-8

RA: former CAS 85005-23-8

RA: CAS 68002-78-8

RA: CAS 68002-79-9

RA: CAS 68541-50-4

RA: CAS 403507-18-6

RA: CAS 403507-18-6

RA: former CAS 85005-23-8

Source 1

68002-78-8

Experimental result: LL50 (96 h) >102 mg/L

--

Experimental result: EL50 (48 h) >106 mg/L

Experimental result: NOELR (21 d) ≥ 110 mg/L

Experimental result: EL50 (72 h) >110 mg/L

--

Source 2

68002-79-9

--

--

Experimental result: EC50 (48 h) >1000 mg/L

--

Experimental result: EL50 (72 h) >100 mg/L

--

Source 3

formerly 85005-23-8

Experimental result: LC50 (96 h) > 100 mg/L

--

Experimental result: EL50 (96 h) > 100 mg/L (RL3)

TESTING PROPOSAL

--

Experimental result: EL50 (16 h) > 10000 mg/L

Source 4

68541-50-4

Experimental result: LC50 (96 h) >48 mg/L

--

Experimental result: EC50 (48 h) > 7.6 mg/L

--

Experimental result: EC50 (72 h) > 3.7 mg/L

--

 

Source 5

403507-18-6

Experimental result: LC50 (96 h) > 0.2 mg/L (nom.)

--

Experimental result: EC50 (48 h) > 0.2 mg/L (nom.)

--

Experimental result: EC50 (72 h) > 0.2 mg/L (nom.)

Experimental result: EC50 (3 h) > 1000 mg/L

 

The above mentioned substances are considered to be similar on the basis of the structural similar properties and/or activities. The available endpoint information on the source substances is used to predict the same endpoints forFatty acids, tall-oil, triesters with trimethylolpropane (CAS 94581-09-6). The target as well as the source substance are all characterized by the same alcohol component (trimethylolpropane) and a similar fatty acid chain lengths (C18:1 for the target substance and C18 unsatd., C18:1, C18 branched, C18 linear&branched and C16-18 (even numbered) and C18 unsat. Liner&branched for the source substances, respectively). All substances are predominantly triesters. A detailed analogue approach justification is provided in the technical dossier (see IUCLID Section 13).

All available experimental data on the source substances performed according to internationally accepted guidelines indicate no evidence of acute and chronic toxicity to aquatic organisms. Data for all three trophic levels are available. No toxicity was observed up to the limit of water solubility in all available experimental studies. The water solubility of the target substance was determined to be 0.6 mg/L at 20 °C for the TMP esters fraction and 6.2 mg/L at 20 °C, pH6 for the total soluble fraction, respectively. The increase in water solubility when measuring the total soluble fraction is caused by the more soluble free fatty acids and the mono- as well as di-esters which increase the overall water solubility of the UVCB substance. For the read-across substances the water solubility was measured only for the TMP-ester-fraction. Considering this, the water solubility values of the target and source substance are all < 1 mg/L and are thus comparable for assessing the aquatic toxicity.
The short-term toxicity to fish was determined in standard OECD guideline studies from suitable read-across substances. No mortality was observed after 96 h resulting in LC50-values > the limit of water solubility. The same was recorded for the short-term toxicity to aquatic invertebrates and to aquatic algae. No immobilization of Daphnia magna and no inhibition of growth of aquatic algae were observed in experimental studies according to OECD guidelines up to the limit of water solubility. Due to the low water solubility, long-term testing to aquatic invertebrates was considered to be necessary to assess the aquatic toxicity. The available study performed with a suitable source substance resulted in a NOELR (21 d) ≥ 0.11 g/L indicating no effects up to the limit of water solubility. Long-term toxicity testing to fish was not considered to be necessary since there was no evidence from the available data that fish are more sensitive compared to aquatic invertebrates. No toxicity to fish was observed in the available acute tests. Thus, in order to avoid unnecessary vertebrate testing, no long-term testing with fish was proposed.
The degradation process in commercial sewage treatment plants is not suspected to be inhibited by the target substance. Available studies performed with activated sludge from sewage treatment plants do not indicate a risk since respiration of activated sludge microorganisms was not inhibited. 

Based on the result from structurally related read-across substances (in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5) it can be concluded thatFatty acids, tall-oil, triesters with trimethylolpropane (CAS 94581-09-6) exhibits no toxic effects on freshwater organisms up to the limit of the water solubility. As it can be seen in the data matrix of the analogue justification in IUCLID Section 13, all reliable data from the target and the source substance support the read-across by showing a consistent pattern of results.