4-methoxybenzyl alcohol

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

Study period:

from 2016-06-20 to 2016-06-24

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:

1992

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

Version / remarks:

2008

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Details on sampling:

- Concentrations: 0 mg/L (control) and 64.0 mg/L
- Sampling method: the limit concentration and the control were sampled daily. The samples after 0 and 96 h were analytically verified.
- Sample storage conditions before analysis: samples were taken and stored at 6 ± 2 °C, if further analysis is necessary.

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: The test item was homogenized by melting at approximately 30 °C for 1 hour. Thereafter, the test item was weighed out and transferred to the test vessel filled with an appropriate volume of dilution water. The test media were mixed with an ultraturrax until the test item is completely dissolved (17000 rpm).

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: zebrafish
- Strain: Danio rerio
- Maintenance of the brood fish: Holding was performed at the test facility at 23 ± 2°C and diffuse light (0.1-10 pmol photons x m^-2 x s^-1, natural photoperiod). The water was changed at least once per week. The dissolved oxygen concentration was more than 80 % of the air saturation value.

ACCLIMATION
- Acclimation period: at least 12 days
- Acclimation conditions: same as test
- Type and amount of food during acclimation: Sera vipan; The amount of food was 4 % of the fish body weight per feeding day.
- Feeding frequency during acclimation: 3 times per week
- Health during acclimation: Zebrafish with mortality < 5% within these days prior to the start of exposure were used for testing.


FEEDING DURING TEST: no

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Hardness:

60 mg/L as CaCO3

Test temperature:

23 ± 2 °C

pH:

7.31 - 7.81

Dissolved oxygen:

81 - 100% oxygen saturation

Salinity:

NA

Conductivity:

174 µS/cm

Nominal and measured concentrations:

nominal: 64 mg/L
measured: 64.9 mg/L (0 hours), 59.7 mg/L (96 hours)

Details on test conditions:

TEST SYSTEM
- Test vessel: Aquaria
- Type: covered with glass plates
- Material, size, fill volume: glass, 13 L (dimensions: 25.5/18/28 cm, depth of water: 20 cm), 10 L fill volume
- Aeration: none
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: 0.155 g fish per litre

TEST MEDIUM / WATER PARAMETERS
- Alkalinity: 0.60 mmol/L
- Acidity: 0.10 mmol/L
- total hardness: 10 - 250 mg CaCO3/L
- Culture medium different from test medium: no
- Intervals of water quality measurement: The pH-value, temperature and oxygen saturation were measured in all test vessels at the start of the exposure and every 24 hours.

OTHER TEST CONDITIONS
- Photoperiod: 16 hours light, 8 hours dark
- Light intensity: 128 and 126 lux

EFFECT PARAMETERS MEASURED: Mortality and visible abnormalities (e.g. loss of equilibrium, swimming behaviour, respiratory function, pigmentation); observations were made after 2, 24, 48, 72 and 96 hours

TEST CONCENTRATIONS
- The selection of the test concentration is based on the derivation of a threshold concentration (TC) from the results of an alga toxicity test (EyCso (0-72 h) 64.2 mg/L (nominal concentration) and a Daphnia acute toxicity test (ECso (48 h) > 100 mg/L (nominal concentration).

Reference substance (positive control):

no

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 64 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC100

Effect conc.:

> 64 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC0

Effect conc.:

>= 64 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

- Behavioural abnormalities: no
- Mortality of control: no
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: The test solution was visibly clear throughout the period of exposure.

Sublethal observations / clinical signs:

Table 1: Observations in the test vessels

Nominal concentration [mg/L]	Effect*	Number of fish effected at observation time (hours)
		2	24	48	72	96
64.0	(1)	7/7	7/7	7/7	7/7	7/7
0	(1)	7/7	7/7	7/7	7/7	7/7

*) The numbers in brackets correspond to the following observations:

(1) = Normal behaviour

Table 2: Cumulative Mortality (%) in the test vessels

Nominal concentration [mg/L]	Cumulative mortality at observation time (hours)
	2	24	48	72	96
64.0	0	0	0	0	0
0	0	0	0	0	0

Table 3: Measured concentrations and percent of nominal concentrations of the test item

	0 hours (start of exposure interval)		96 hours (end of exposure interval)
Nominal concentration [mg/L]	Measured conc. [mg/L]	%	Measured conc. [mg/L]	%
64.0	64.9	101	59.7	93
control	< LOQ		< LOQ

Meas. conc = measured concentration of the test item, dilution factor taken into account

% = percent of the nominal test item concentration

LOQ = limit of quantification of the analytical method (0.5 mg/L of the test item)

Validity criteria fulfilled:

yes

Conclusions:

The limit concentration of the test item was found to have no effect on the vitality of zebrafish. The LC50 corresponds to the nominal concentration > 64.0 mg/L.

Executive summary:

The acute toxicity of the test item to fish (zebrafish) was determined according to the OECD Guideline 203 and EU Council Regulation No. 440/2008/C.1. A static test was performed as a limit test with a concentration of 64.0 mg/L. The selection of the test concentration is based on the derivation of a threshold concentration (TC) from the results of an alga toxicity test (EyCso (0-72 h) 64.2 mg/L) and a Daphnia acute toxicity test (ECso (48 h) > 100 mg/L). Seven test organisms were exposed to the test concentration and the control, respectively, for 96 hours. The measured concentration of the test item at the start of exposure (0 h) was 101% of the nominal value. The measured concentration at the end of exposure (96 h) was 93% of the nominal value. Therefore, all effect values were based on the nominal concentration of the test item. The limit concentration of the test item was found to have no effect on the vitality of zebrafish. In conclusion, the LC0 corresponds to the nominal concentration > 64.0 mg/L. The LC50 and the LC100 correspond to the nominal concentration > 64.0 mg/L.

Description of key information

The LC50 of the test item was determined to be > 64.0 mg/L in study performed according to OECD Guideline 203.

Additional information

The acute toxicity of the test item to fish (zebrafish) was determined according to the OECD Guideline 203 and EU Council Regulation No. 440/2008/C.1. A static test was performed as a limit test with a concentration of 64.0 mg/L. The selection of the test concentration is based on the derivation of a threshold concentration (TC) from the results of an alga toxicity test (EyC₅₀ (0-72 h) 64.2 mg/L) and a Daphnia acute toxicity test (EC₅₀ (48 h) > 100 mg/L). Seven test organisms were exposed to the test concentration and the control, respectively, for 96 hours. The measured concentration of the test item at the start of exposure (0 h) was 101% of the nominal value. The measured concentration at the end of exposure (96 h) was 93% of the nominal value. Therefore, all effect values were based on the nominal concentration of the test item. The limit concentration of the test item was found to have no effect on the vitality of zebrafish. In conclusion, the LC₀ corresponds to the nominal concentration≥64.0 mg/L. The LC₅₀ and the LC₁₀₀ correspond to the nominal concentration > 64.0 mg/L.