Dipentaerythritol hexaesters of 3,5,5-trimethylhexanoic and n-heptanoic acids

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

short-term toxicity to fish

Type of information:

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

Adequacy of study:

key study

Justification for type of information:

In accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5 a read across from the structurally similar analogue substance EC 444-000-20-2 was conducted to fulfil the data requirements according to Annex VII of Dipentaerythritol hexaesters of 3,5,5-trimethylhexanoic and n-heptanoic acids. (CAS 1379424-11-9) in regards to sort-term toxicity to fish.
This read-across is justified in detail in the overall summary (IUCLID seccion 6.1) and within the analogue justification in IUCLID section 13. The source substance consists of the same alcohol component (dipentaerythritol) and similar fatty acid chain lengths as the target substance (C5, C9-iso for the source substance compared to C7, C9-iso for the target substance).

The toxicity to fish of the source substance EC number 444-000-2 was investigated in a GLP study according to OECD 203. Rainbow trouts were exposed to a nominal concentration of 100 mg/L (freshwater, static). No effects were observed. This study resulted in an LC50 (96 h) of 100 mg/L (nominal) and a NOEC(96 h) > or = to 100 mg/L.

Based on the results found for the structurally related substance, characterized by a similar ecotoxicological profile and in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5, it can be concluded that Dipentaerythritol hexaesters of 3,5,5-trimethylhexanoic and n-heptanoic acids will not exhibit toxic effects to fish up to the limit of water solubility.

Reason / purpose for cross-reference:

read-across source

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Basis for effect:

mortality (fish)

Key result

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Basis for effect:

mortality (fish)

Conclusions:

An available study with the subsance EC number 444-000-2 investigated the toxicity to fish in a GLP study according to OECD 203. Rainbow trouts were exposed to a nominal concentration of 100 mg/L (freshwater, static). No effects were observed. This study resulted in an LC50 (96 h) of 100 mg/L (nominal) and a NOEC(96 h) > or = to 100 mg/L.

Based on the result from the structurally related substance, characterized by a similar ecotoxicological profile and in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5 (read-across from a surrogate), it can be concluded that the substance Dipentaerythritol hexaesters of 3,5,5-trimethylhexanoic and n-heptanoic acids (EC number 945-883-1) will not exhibit toxic effects to fish up to the limit of water solubility.

Executive summary:

An available study with the subsance EC number 444-000-2 investigated the toxicity to fish in a GLP study according to OECD 203. Rainbow trouts were exposed to a nominal concentration of 100 mg/L (freshwater, static). No effects were observed. This study resulted in an LC50 (96 h) of 100 mg/L (nominal) and a NOEC(96 h) > or = to 100 mg/L.

Based on the result from the structurally related substance, characterized by a similar ecotoxicological profile and in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5 (read-across from a surrogate), it can be concluded that the substance Dipentaerythritol hexaesters of 3,5,5-trimethylhexanoic and n-heptanoic acids will not exhibit toxic effects to fish up to the limit of water solubility.

Reference 2

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

GLP compliance:

yes

Details on test solutions:

Identity and concentration of auxiliary solvent for dispersal: No additional solvents used for dispersal

Test organisms (species):

Oncorhynchus mykiss (previous name: Salmo gairdneri)

Test type:

static

Water media type:

freshwater

Limit test:

yes

Hardness:

CA 100 mg CaCO3/L

Nominal and measured concentrations:

Nominal concentration of 100 mg/L.
Measured concentration < 0.00613 mg/L (limit of quantification)

Details on test conditions:

A 100 mg/L solution was prepared by direct addition followed by stirring for 23 hours.
The solution was allowed to stand for 1 hour and then filtered through a 0.45micron filter to remove globules of test material.
The resulting solution was tested and no effects were
observed.

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Basis for effect:

mortality (fish)

Key result

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Basis for effect:

mortality (fish)

Details on results:

Analysis of exposure solutions at 0, 24 and 96 hours showed that test concentrations were below the limit of quantification, 0.00613 mg/L.

Since no effects were observed:
96h LC50 > Limit of solubility
96h NOEC > or = Limit of solubility.

Validity criteria fulfilled:

yes

Conclusions:

LL50 (96 h) > 100 mg/L (nominal) (Onchorhynchus mykiss, OECD 203)
No effects up to the limit of the water solubility of the substance.

Description of key information

No toxic effects to fish were observed up to the limit of water solubility (OECD 203) for the structural analogue substance EC 444 -000 -2 :

LL50 (96 h) > 100 mg/L (nominal) (Onchorhynchus mykiss, OECD 203)

NOEC (96 h)  ≥ 100 mg/L

Based on the result from the structurally related substance, characterized by a similar ecotoxicological profile and

in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5, it can be concluded that Dipentaerythritol hexaesters of 3,5,5-trimethylhexanoic and n-heptanoic acids will not exhibit short-term toxic effects to fish up to the limit of water solubility.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

100 mg/L