Butane-1,3-diol

Short-term toxicity to fish

Link to relevant study record(s)

Reference

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)

Version / remarks:

adopted 1992

Deviations:

no

GLP compliance:

yes

Analytical monitoring:

yes

Details on sampling:

- Concentrations: 0 and 100 mg/L after at study initiation and after 48 h of exposure
- Sample storage conditions before analysis: no data

Vehicle:

no

Details on test solutions:

1) An aqueous solution of 0.1% of the weight of the tested substance was added to the dilution water, and study solution of the set concentration was adjusted to the required quantity.
2) A control solution with only diluted water was created.
3) The state of the study solution (exterior, etc.) was observed. It was colorless and transparent, and precipitation etc. was not seen.

Test organisms (species):

Oryzias latipes

Details on test organisms:

TEST ORGANISM
- Common name: Himedaka
- Source: Six B Fish Farm (date of purchase: Dec. 5th, 1996)
- Age at study initiation (mean and range, SD):
- Length at study initiation (length definition, mean, range and SD): 1.83 cm (1.62 to 2.14 cm)
- Weight at study initiation (mean and range, SD): 0.091 h (0.062 to 0.157 g)
- Feeding during test: no feeding during test

ACCLIMATION
- Acclimation period: 14 d
- Acclimation conditions (same as test or not): yes
- Type and amount of food: Tetramin
- Feeding frequency: no data (no feeding 24-h prior to test start)
- Health during acclimation (any mortality observed): death rate 7 d prior to test start: 0%

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Hardness:

dilution water: 21.8 mg/L (as CaCO3)

Test temperature:

23.3 to 23.8 °C

pH:

6.4 to 6.8

Dissolved oxygen:

freshly prepared test solution: 10.3 to 10.6 mg/L
replaced test solutions (after 48 h of exposure): 5.91 to 7.19 mg/L

Nominal and measured concentrations:

Nominal: 100 mg/L
Measured: 85.6 mg/L (0 h) / 99.9 mg/L (48 h, after renewal)

Details on test conditions:

TEST SYSTEM
- Test vessel:
- Type (delete if not applicable): open
- Material, size, headspace, fill volume: 3- glass beaker
- Aeration:
- Renewal rate of test solution (frequency/flow rate): once after 48 h
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: carbon-filtered and dechlorinated tap water (Nagoya City tap water)


TEST CONCENTRATIONS
- Spacing factor for test concentrations: -
- Justification for using less concentrations than requested by guideline: limit test

Reference substance (positive control):

yes

Remarks:

Copper sulfate pentahydrate

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Details on results:

- Behavioural abnormalities: no
- Mortality of control: 0%
- Other adverse effects control: no
- Abnormal responses: no
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: no
- Effect concentrations exceeding solubility of substance in test medium: no

Results with reference substance (positive control):

- Results with reference substance valid? yes
- LC50: 0.16 mg/L

Sublethal observations / clinical signs:

Mortality: no mortality or symptoms were noted during exposure

Analytical monitoring:

Test concentrations
nominal	measured [mg/L]			[% of nominal]
	0 h	48 h	geometric mean	0 h	48 h
	freshly prepared	replaced		freshly prepared	replaced
0 (control)	< 20	< 20	---	---	---
100	85.6	99.9	92.5	85.6	99.9

Validity criteria fulfilled:

yes

Conclusions:

The 96-h LC50 for acute toxicity to the Medaka/Killifish (Oryzias latipes) of 1,4-butanediol was > 100 mg/L.

Executive summary:

The acute toxicity of 1,4 -butanediol was tested under semi-static conditions in a 96 -h toxicity study on the killifish (Oryzias latipes) following OECD TG 203. 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.

Description of key information

96-h LC50 > 100 mg/L (OECD 203, Env. Agency of Japan, 1997)

Additional information

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. Calculated results are available for 1,3 -butanediol, indicating that the acute toxicity to fish is beyond 1000 mg/L (e.g. FoBiG, 2017, RL2). Reagrding the remaining studies only abstracts are available, the reliability score is 4 (not assignable), but the results are published under reviewed programmes and by reliable organisations like ECB (see summary of results below).

Test substance	Fish species	LC50 [mg/L]	Reliability	Remark	Reference
1,4-butanediol (C4)	Oryzias latipes	> 100 (96 h)	1	key study; measured; analytical monitoring	Environmental Agency of Japan, 1997
1,4-butanediol (C4)	Oryzias latipes	> 100 (14 d)	1	supporting study; measured; analytical monitoring	Environmental Agency of Japan, 1997
1,3-butanediol (C4)	not defined	9514 (96 h)	4	calculated	Daly, 2000
1,3 -butanediol (C4)	Pimephales promelas	22200 (96h)	2	calculated	FoBiG, 2017
1,4 -butanediol (C4)	Cyprinus carpio	> 1240 (96 h)	4	measred; analytical monitoring	ECB, 2000