Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Short-term toxicity to fish

96h-LC50 > 100 mg/L (OECD 203)

Short-term toxicity to aquatic invertebrates

48h-EC50 (Daphnia magna, immobility) > 1000 mg/L (OECD 202)

Toxicity to aquatic algae

72h-ErC50 (Desmodesmus subspicatus, respiration) > 1070 mg/L (mean measured concentrations, OECD 201)

72h-NOErC (Desmodesmus subspicatus, respiration) > 1070  mg/L (mean measured concentrations, OECD 201)

Long-term toxicity to fish

Data waiving in accordance with column 2 of REACH Annex IX.

Long-term toxicity to aquatic invertebrates

21d-NOEC (Daphnia magna, reproduction) > 85 mg/L (OECD 211)

Toxicity to microorganisms

3h-EC50 (respiration inhibition, activated sludge) > 100 mg/L (OECD 209)

40h-IGC50 (growth inhibiting effect to ciliate Tetrahymena pyriformis) = 18035 mg/L (TETRATOX assay)

Additional information

Summary aquatic toxicity

In summary, butane-1,3 -diol did not show any acute or chronic toxicity to the aquatic organisms up to a limit concentrations of 100 or 1000 mg/L. Therefore, butan-1,3 -diol is considered to be non-hazardous to the aquatic environment.

Short-term toxicity to fish

Read-across approach: butane-1,4 -diol (source), butane-1,3 -diol (target) (see also Read-across justification in IUCLID section 13)

In the available key study, acute toxicity of the source substance 1,4 -butanediol was tested under semi-static conditions in a 96 -h toxicity study on the killifish (Oryzias latipes) following OECD TG 203 (RL1). Analytical verification of the test substance concentrations at test start and after renewal (48 h) revealed recovery rates of > 80 %. Based on nominal concentrations, the 96 -h LC50 was determined to be > 100 mg/L for source and target substance (no conversion factor applied as source and target compound have the same molecular weight). In the supporting prolonged toxicity study, adverse effects of 1,4 -butanediol was tested under flow-through conditions in a 14 -d toxicity study on the Medaka/Killifish (Oryzias latipes) following OECD TG 204 (RL1). A limit test with 100 mg/L and a control were set up. Analytical verification of the test substance concentrations at test start, after 7 and 14 d revealed recovery rates of > 80 %. Based on nominal concentrations, the 14 -d LC50 was determined to be > 100 mg/L for source and target substance.

Short-term toxicity to invertebrates / long-term toxicity to invertebrates

Read-across approach: butane-1,4 -diol (source), butane-1,3 -diol (target) (see also Read-across justification in IUCLID section 13)

In the available key study, acute toxicity of the source compound 1,4 -butanediol was tested under static conditions in a 48 -h toxicity study on the water flea (Daphnia magna) following OECD TG 202 (RL2). Analytical verification of the test substance concentrations revealed recovery rates of > 80 % after 48 h. Based on nominal concentrations, the 48 -h EC50 was determined to be > 1000 mg/L for source and target substance (no conversion factor applied as source and target compound have the same molecular weight).

In the available key study, the source substance butane-1,4 -diol was tested for effects on reproduction of Daphnia magna in a 21 -d semi-static study following OECD TG 211 (1984, RL1). A limit test with the nominal concentration of 100 mg/L was set up. Analytical verification of the test substance concentration revealed a mean measured concentration of 85 mg/L. No adverse effects were determined. The determined 21 -d NOEC was > 85 mg/L (mean measured concentrations), which was derived for source and target substance (no conversion factor applied as source and target compound have the same molecular weight).

Toxicity to aquatic algae

In the available key study, algae growth inhibitory effects of 1,3 -butanediol were studied on Desmodesmus subspicatus following OECD 201 (adopted 1984, RL1). A 72 -h limit test with a control (0 mg/L) and the nominal test concentration of 1000 mg/L was set up. Analytical verification of the test concentrations by GLC-FID demonstrated good recovery and revealed a mean measured concentration of 1070 mg/L. The physical-chemical parameters were within acceptable limits. Based on mean measured concentrations, the 72-h ErC50 is > 1070 mg/L and the 72-h NOErC is > 1070 mg/L.

Toxicity to microorganisms

Weight of evidence approach for toxicity to microorganisms of butane-1,3 -diol

There were two studies available that tested the toxicitiy of butane-1,3 -diol to microorganisms. In the first study, the effects of 1,3 -butanediol on the respiration rate of activated sludge were tested in a 3 -h respiration inhibition test following OECD TG 209 (RL2). Three test concentrations plus two controls (0 mg/L) were set up: 1, 10, 100 mg/L. The highest concentration was tested in triplicate. The test substance showed no adverse effects up to 100 mg/L. Therefore, the 3 -h EC50 > 100 mg/L. The validity criteria were fulfilled. In the other study, the growth inhibiting effect of 1,3 -butanediol on the ciliate Tetrahymena pyriformiswas determined using the TETRATOX assay (RL2). The resulting IGC50 (40 h) of 18035 mg/L indicated no significant toxicity of 1,3 -butanediol to microorganisms (ciliates).