Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Additional information

There are no data available for the long-term toxicity to aquatic invertebrates of Reaction mixture of Glycerol 1,3- di(acetate), glycerol acetate and triacetin. In order to fulfil the standard information requirements set out in Annex VII, 8.5, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006, read-across from one structurally related substance 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 human 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 substance Reaction mixture of Glycerol 1,3- di(acetate), glycerol acetate and triacetin and the source substance triacetin are presented in the following table.

CAS

no CAS

102-76-1

Chemical Name

Reaction mixture of Glycerol 1,3- di(acetate), glycerol acetate and triacetin

triacetin

MW

134.13 - 218.20

218.20

 

 

 

Short-term toxicity to fish

LC50 (96 h): > 1000 mg/L

LC50 (96 h): > 100 mg/L

LC50 (96 h): 174 mg/L

NOEC (14 d): ≥ 100 mg/L

Long-term toxicity to fish

Exposure based adaptation

--

Short-term toxicity to aquatic invertebrates

EC50 (48 h): > 2000 mg/L

 

EC50 (48 h): 380 mg/L

EC50 (48 h): 770 mg/L

Long-term toxicity to aquatic invertebrates

RA: CAS 102-76-1

NOEC (21 d): ≥ 94 mg/L

Toxicity to aquatic algae

ErC50 (72 h): 632.5 mg/L

ErC50 (72 h): > 940 mg/L

Toxicity to microorganisms

NOEC (3 h): ≥ 1000 mg/L

NOEC (18 h): > 1088 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 is used to predict the same endpoints for Reaction mixture of Glycerol 1,3- di(acetate), glycerol acetate and triacetin.

A detailed analogue approach justification is provided in the technical dossier (see IUCLID Section 13). In accordance with Regulation (EC) No. 1907/2006, Annex XI, 1.5, grouping and read-across, the target substance Reaction mixture of Glycerol 1,3- di(acetate), glycerol acetate and triacetin and the source substance triacetin (CAS 102-76-1) are not considered to be harmful to aquatic organisms based on the results from short-term studies with fish, aquatic invertebrates and algae and long-term results on toxicity to aquatic invertebrates. Both substances are structurally similar. Triacetin is one major component of Reaction mixture of Glycerol 1,3- di(acetate), glycerol acetate and triacetin. The data gap for long-term toxicity to aquatic invertebrates was adequately filled since both substances are characterized by a similar pattern in the ecotoxicological toxicity profile. No trend in toxicity was observed since no effects were recorded up to 100 mg/L. There is no convincing evidence that any one of the two substances might lie out of the overall ecotoxicological profile. Short-term studies investigating the toxicity of Reaction mixture of Glycerol 1,3- di(acetate), glycerol acetate and triacetin to aquatic organisms from three different trophic levels are available. The results from the acute studies show that Reaction mixture of Glycerol 1,3- di(acetate), glycerol acetate and triacetin has a low toxicity to aquatic organisms. The substance did not cause any effects to fish up to a nominal concentration of 1000 mg/L (LC50 (96 h) > 1000 mg/L) and no immobilization of Daphnia magna up to a nominal concentration of 2000 mg/L (EC50 (48 h) > 2000 mg/L). Low toxicity was observed on the growth rate of the marine algae Skeletonema costatum resulting in an EC50 (72 h) of 632.5 mg/L. One chronic study is available for the source substance triacetin indicating no toxicity up to 94 mg/L (measured) resulting in a NOEC ≥ 94 mg/L. Since triacetin is one of the major components of Reaction mixture of Glycerol 1,3- di(acetate), glycerol acetate and triacetin and considering the similar ecotoxicological profile based on the available data, it is justified using the data from the source substance as read-cross for Reaction mixture of Glycerol 1,3- di(acetate), glycerol acetate and triacetin. Available short-term toxicity data from triacetin did not exhibit effects up to a nominal concentration of 100 mg/L. Fish turned out to be the most sensitive species with an LC50 (96 h) of 174 mg/L. Based on the results from a respiration inhibition study it can be concluded that Reaction mixture of Glycerol 1,3- di(acetate), glycerol acetate and triacetin is not expected to exhibit effects on the microorganism community in sewage treatment plants and inhibition of the subsequent degradation process is not expected (NOEC (3 h) ≥ 1000 mg/L).

 In conclusion, the target substance Reaction mixture of Glycerol 1,3- di(acetate), glycerol acetate and triacetin is of low toxicity to aquatic organisms. No effects on aquatic organisms up to 100 mg/L were observed in the available short-term studies. Furthermore, a long-term study with the main component triacetin did not result in any effect on mobility of aquatic invertebrates. 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 for the endpoint long-term toxicity to aquatic invertebrates by showing a consistent pattern of results.