Isooctadecyl pivalate

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to fish

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reason / purpose for cross-reference:

read-across source

Analytical monitoring:

no

Duration:

96 h

Dose descriptor:

LL50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other:

Remarks:

Source: RA-A, Isononyl pivalate, Stearinerie, 2013, D. rerio, 96 h

Conclusions:

Based on the results of the source study study, the LL50 was > 100 mg test item/L and the NOEL based on the visual observation was >= 100 mg/L.

Executive summary:

In the 96 h acute toxicity test according to OECD 203 with the source substance Isononyl pivalate, zebrafish were exposed to a Water Accommodated Fraction (WAF) at a nominal loading concentration of 100 mg/L under semi-static conditions. Seven fish were used for treatment and in the control. Neither clinical signs nor mortality were observed throughout the study.

Based on the results of this study, the LL50 is > 100 mg test item/L and the NOEC based on the visual observation is >= 100 mg/L (NOEL >= 100 mg/L). This toxicity study is classified as acceptable and satisfies the guideline requirement for “Fish, Acute Toxicity Test”

Description of key information

No effects up to the water solubility limit (1.0 - 27 µg/L, mean: 11.7 µg/L; OECD 203)

Additional information

Since no studies investigating the short-term toxicity of Isooctadecyl pivalate (CAS 58958-60-4) to fish are available for this endpoint, in accordance to Regulation (EC) No. 1907/2006 Annex XI, 1.5 a read across to the structurally related source substance Isononyl pivalate was conducted. The source substance is characterized by the same fatty acid component (pivalic acid) and a smaller fatty alcohol chain length (C9 iso) (source substance) compared to the target substance. The read-across substance represents a worst case, since the smaller substance is expected to have a higher bioavailability compared to the target substance. Since both substances share common similar functional groups and neither the target nor the source substance consist of any structural alerts leading to a different toxicity profile this read-across is suitable. This read-across is further justified within the analogue justification in IUCLID Section 13. In this case of read-across, the best suited (highest degree of structural similarity, nearest physico-chemical properties) source substance was used for the assessment.

The study available for the read-across substance Isononyl pivalate was performed according to OECD 203 under GLP-conditions. Danio rerio was exposed to a nominal loading rate of 100 mg/L (limit test). The test solutions were prepared as Water Accommodated Fractions (WAFs) to exclude physical effects due to the poor solubility of the substance in water. No analytical measurements were performed to verify the nominal loading rates. After an exposure of 96 h, no mortality was observed and a LL50 > 100 mg/L was determined.

Based on the available result from one structurally related source substance (in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5) which is characterized by a comparable structure, it can be concluded that Isooctadecyl pivalate will not exhibit acute toxicity to fish up to the limit of water solubility (1.0 - 27 µg/L, mean: 11.7 µg/L).