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There are no data available covering the short-term fish toxicity of isodecyl pivalate (CAS 60209-82-7). In order to fulfill the standard information requirements set out in Annex VII - IX, 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 isodecyl pivalate (CAS 60209-82-7) and the source substance are presented in the following table.

 

Target substance

Source substance

CAS

60209-82-7

--

Chemical Name

Isodecyl pivalate

Isononyl pivalate

Molecular weight

242.40

228.37

Water solubility

< 0.05 mg/L

< 0.05 mg/L

Log Kow

3.54 (OECD 117)

6.08 (QSAR)

5.52

Fatty acid chain length

Pivalic acid

Pivalic acid

Alcohol

C10

C9

Short-term toxicity to fish

Read across: Isononyl pivalate

LL50 (96 h): > 100 mg/L

Long-term toxicity to fish

Waiving based on CSA

--

Short-term toxicity to aquatic invertebrates

Waiving

--

Long-term toxicity to aquatic invertebrates

NOELR (21 d): < 13.45 µg/L (meas. TWM)

--

Toxicity to aquatic algae

Waiving

--

Toxicity to microorganisms

NOEC (3 h):≥1000 mg/L

--

Lack of data for a given endpoint is indicated by “--“.

 

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 isodecyl pivalate. 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 isodecyl pivalate (CAS 60209-82-7) and the source substance isononyl pivalate are considered to be structurally very similar. The difference between both substances is the chain length of the alcohol component. The alcohol chain length is C10 for the target substance and C9 for the source substance whereas the fatty acid component is the same for both substances (pivalic acid). Based on the very close structural similarity it is justified to use isononyl pivalate as read-across substance and to cover the endpoint “Short-term toxicity to fish” by read-across. Moreover, the target and the source substance are characterized by a similar profile in relevant physico-chemical properties like log Kow, log Koc and water solubility implying a similar environmental behaviour and distribution.

 

For the target substance studies are available investigating the short-term and long-term toxicity to aquatic invertebrates as well as the toxicity to activated sludge microorganisms. The short-term study conducted with Daphnia magna was not used for the hazard assessment since relevant information are missing for a reliable evaluation of the results (reliability score 3). No clear information on the control and on the applied test concentrations is given. Moreover, the documentation of the methodological procedure of the study is very short missing relevant information for a reliable assessment. However, effects on mobility were observed in this study. Two long-term studies according to OECD 211 are available. The studies were conducted as semi-static limit tests. One of the tests was conducted with limit concentration of 100 mg/L (nominal, WAF). Analytical dose verification of fresh and aged test solutions determined a test item concentration of 13.34 µg/L, time weighted mean (TWM). The test reported no effect on survival and growth of Daphnids but a significant reduction of the reproduction rate. A NOEC could not be determined as the study was performed as a limit test. Thus it was set to NOELR (21 d) < 13.34 µg/L (TWM). The limit concentration in the second test was 2 mg/L (nominal). The test did not include an analytical dose verfication. A significant reduction of the reproduction rate was observed and the NOEL (21 d) was set to < 2 mg/L (nominal).

No acute effects on fish up to the limit of water solubility (< 0.05 mg/L) were observed in the study conducted with the read-across substance isononyl pivalate in a study according to OECD 203 resulting in a LL50 (96 h) > 100 mg/L (nominal). A long term test with fish is considered to be unnecessary due to: a) the fact that fish is not the most sensitive species among all three trophic levels, b) as the risk characterization ratios (RCR) were < 1 for the aquatic compartment and c) the fact that isodecyl pivalate is already classified as Chronic Category 1 (H410) according to CLP. Therefore, due to animal welfare reasons and to avoid unnecessary vertebrate tests, no further long-term test with fish is provided.

Additional testing with aquatic algae was not considered to be necessary based on the intrinsic properties of the substance like the low water solubility and the environmental exposure assessment accordingto Regulation (EC) No 1907/2006, Annex XIII.All Risk Characterisation Ratios (RCR) were < 1 based on the available data.

Based on the result from an activated sludge respiration inhibition test according to OECD 209 it can be concluded that isodecyl pivalate 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 (nominal)).