Formic acid, manufacture of, by-products from

Long-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Endpoint:

long-term toxicity to aquatic invertebrates

Type of information:

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

Adequacy of study:

weight of evidence

Justification for type of information:

It is considered appropriate to address the data requirements for reaction mass of 2,2-bis(formyloxymethyl)propane-1,3-diyl diformate and formic acid by read-across to the available studies on structurally similar substances.
Reaction mass of 2,2-bis(formyloxymethyl)propane-1,3-diyl diformate and formic acid is comprised of formic acid (free) up to 59%, propylidynetrimethanol (trimethylolpropane, TMP) up to 35%, and pentaerythritol up to 19.6%.
Long-term aquatic invertebrate toxicity studies are available on formic acid, propylidynetrimethanol (trimethylolpropane, TMP), and pentaerythritol. The data requirements for reaction mass of 2,2-bis(formyloxymethyl)propane-1,3-diyl diformate and formic acid are addressed by read-across to formic acid, propylidynetrimethanol (TMP) and pentaerythritol.

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Specific details on test material used for the study:

Formic acid, propylidynetrimethanol (trimethylolpropane, TMP), and pentaerythritol are being used as a read across for 2,2-bis(formyloxymethyl)propane-1,3-diyl diformate and formic acid.

Key result

Duration:

21 d

Dose descriptor:

NOEC

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

reproduction

Remarks on result:

other: Key data from formic acid study

Duration:

21 d

Dose descriptor:

NOEC

Effect conc.:

> 1 000 mg/L

Remarks on result:

other: Key data from TMP study

Duration:

21 d

Dose descriptor:

NOEC

Effect conc.:

1 000 mg/L

Nominal / measured:

nominal

Conc. based on:

not specified

Basis for effect:

reproduction

Remarks on result:

other: Key data from pentaerythritol study

Details on results:

The key data from long-term aquatic invertebrate toxicity studies on formic acid, propylidynetrimethanol (trimethylolpropane, TMP), and pentaerythritol are used for weight of evidence read across to reaction mass of 2,2-bis(formyloxymethyl)propane-1,3-diyl diformate and formic acid.

Validity criteria fulfilled:

yes

Conclusions:

The long-term toxicity of the target substance, reaction mass of 2,2-bis(formyloxymethyl)propane-1,3-diyl diformate and formic acid, to aquatic invertebrates was estimated to be 21 d NOEC = ≥100 mg/L, based on a worst case read-across study on formic acid exposure to D. magna.

Executive summary:

Long-term studies are available on the chronic toxicity to Daphnia for the read-across substances formic acid, propylidynetrimethanol (trimethylolpropane, TMP), and pentaerythritol:

A long-term study exists for the read-across substance, formic acid. To determine chronic effects of formic acid to aquatic invertebrates, a semi-static GLP study according to OECD guideline 211 using Daphnia magna was performed. The calculated NOEC value (21 d) in this study was 100 mg/L, related to the nominal concentrations which were verified analytically (BASF SE, 2007).

A static 21 d test was performed with TMP on D. magna which followed an OECD Guideline not further specified, which determined a NOEC of >1000 mg/L. The study was performed by the Japanese Environmental Agency according to an OECD-Guideline, and is considered to be acceptable.

Four replicates, each containing 10 female D. magna, were exposed to a series of concentrations of pentaerythritol in a semi-static for a 21 d period. There was no adult mortality during the study, therefore the 21 d LC50 was observed to be >1000 mg/L (the highest nominal exposure concentration tested). There were no significant differences in the number of juveniles produced per female in the control and test treatments during the study. Therefore, the no-observed effect concentration based on reproduction was 1000 mg/L (the highest nominal exposure concentration tested).

Description of key information

The 21 day NOEC for reproduction was found to be >100 mg/l.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

100 mg/L

Additional information

Long-term studies are available on the chronic toxicity to Daphnia for the read-across substances formic acid, propylidynetrimethanol (trimethylolpropane, TMP) and pentaerythritol:

A long-term study exists for the read-across substance, formic acid. To determine chronic effects of formic acid to aquatic invertebrates, a semi-static GLP study according to OECD guideline 211 using Daphnia magna was performed. The calculated NOEC value (21 d) in this study was 100 mg/L, related to the nominal concentrations which were verified analytically (BASF SE 2007).

A static 21 d test was performed with TMP on D. magna by following a OECD Guideline not further specified.

A NOEC > 1000 mg/L was determined. Being performed by EA Japan according to a OECD-Guideline, the study is considered to be acceptable.

Four replicates, each containing 10 female D. magna, were exposed to a series of concentrations of pentaerythritol in a semi-static for a 21 d period. There was no adult mortality during the study, therefore the 21 d LC50 was observed to be >1000 mg/L (the highest nominal exposure concentration tested). There were no significant differences in the number of juveniles produced per female in the control and test treatments during the study. Therefore, the no-observed effect concentration based on reproduction was 1000 mg/L (the highest nominal exposure concentration tested).