butyl 4-hydroxybenzoate

Short-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Qualifier:

according to guideline

Guideline:

ISO 6341 (Water quality - Determination of the Inhibition of the Mobility of Daphnia magna Straus (Cladocera, Crustacea))

GLP compliance:

no

Analytical monitoring:

no

Vehicle:

yes

Details on test solutions:

- Method: Stock solutions were prepared in methanol and serially diluted in distilled water to obtain the target concentrations. The methanol concentration in the exposure solutions, including controls, was 0.01% (v/v) in distillate water in the tested solutions, which is a non-effect dose as estimated in preliminary tests.
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): Methanol

Test organisms (species):

Daphnia magna

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Details on test conditions:

EFFECT PARAMETERS MEASURED (with observation intervals if applicable): immobilisation, every 24 hours
RANGE-FINDING STUDY: yes

Reference substance (positive control):

yes

Remarks:

Potassium dichromate

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

6.2 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

6 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Duration:

48 h

Dose descriptor:

LOEC

Effect conc.:

3.2 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Validity criteria fulfilled:

not specified

Reference 2

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Qualifier:

according to guideline

Guideline:

other: U.S. Environmental Protection Agency. 2002. Methods for measuring the acute toxicity of effluents and receiving waters to freshwater and marine organisms, 5th ed. EPA-821-R-02-012.

GLP compliance:

no

Analytical monitoring:

no

Vehicle:

yes

Details on test solutions:

- Method: To prepare test solutions parabens were dissolved in high-performance liquid chromatography grade acetone and delivered into reconstituted hardwater (RHW) at 0.1% acetone.
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): acetone

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Water flea
- Age: <24 h old neonates

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Test temperature:

24 °C

Nominal and measured concentrations:

Five test concentrations

Details on test conditions:

TEST SYSTEM
- Test vessel:
Material, size, headspace, fill volume: 100 mL beaker filled with 80 mL test solution
- Aeration: no
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Reconstituted hard water (RHW)
- Water quality parameters of Reconstituted hard water (RHW):
pH: 5 8.2 to 8.8
dissolved oxygen: 7.1 to 9.0 mg/L
conductivity: 535 to 588 µS/cm
alkalinity: 110 to 120 mg/L as CaCO3
hardness: 160 to 175 mg/L as CaCO3


OTHER TEST CONDITIONS
- Photoperiod: 16:8 light:dark cycle

VEHICLE CONTROL PERFORMED: yes (0.1% acetone solvent control)

Reference substance (positive control):

not specified

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

5.3 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Reported statistics and error estimates:

For all acute tests, LC50 values were calculated using the probit method, if assumptions were met, or a trimmed Spearman–Karber method, if assumptions for the probit method were not met.

Validity criteria fulfilled:

not specified

Reference 3

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Qualifier:

no guideline followed

Principles of method if other than guideline:

Planarians were exposed for 48 h and 96 h to the test item. LC50 values based on mortality were determined.

GLP compliance:

no

Analytical monitoring:

no

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: All stock solutions were prepared in reconstituted water (ISO 1982), including 2.5 mmol/L CaCl2, 0.4 mmol/L MgSO4, 0.8 mmol/L NaHCO3, and 77 mmol /L KCl.

Test organisms (species):

other: Dugesia japonica

Details on test organisms:

TEST ORGANISM
- Common name: Planarian
- Source: collected from Nan-shi stream located in Wu-Lai (24° 790 N, 121° 520 E) of northern Taiwan
- Feeding during test: not fed at least 4 days before testing
- Body length: 0.7 ± 0.1 cm

ACCLIMATION
- Acclimation conditions: After collecting the animals have been maintained asexually in dechlorinated tap water at room temperature and were fed with raw chicken liver once a week.

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Test temperature:

25 ± 1 °C

Nominal and measured concentrations:

control, 0.5 to 50 mg/L (nominal) (at least five different concentrations)

Details on test conditions:

TEST SYSTEM
- Test vessel:
Material, size, headspace, fill volume: glass beakers filled with 50 mL test solution
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 5

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: reconstituted water according to ISO 6341 (1982)

OTHER TEST CONDITIONS
- Photoperiod: 12:12 dark:light cycle

EFFECT PARAMETERS MEASURED (with observation intervals if applicable): mortality was inspected every 24 h

Reference substance (positive control):

no

Duration:

24 h

Dose descriptor:

LC50

Effect conc.:

8.7 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Remarks on result:

other: 96% CL: 8.4-9.1 mg/L

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

7.8 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Remarks on result:

other: 95% CL: 7.3-8.3 mg/L

Duration:

72 h

Dose descriptor:

LC50

Effect conc.:

7.6 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Remarks on result:

other: 95% CL: 7.2-8.2 mg/L

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

7.3 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Remarks on result:

other: 95% CL: 6.8-7.9 mg/L

Reported statistics and error estimates:

LC50 were calculated using trimmed Spearman–Karber analysis with trimmed Spearman–Karber program (version 1.5).

Validity criteria fulfilled:

not applicable

Reference 4

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Version / remarks:

2004

GLP compliance:

no

Remarks:

guideline study/publication without detailed documentation

Analytical monitoring:

yes

Details on sampling:

- Concentrations: all, at start and end of test

Vehicle:

no

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Water flea
- Source: National Institute for Environmental Studies (Tsukuba, Japan).
- Breeding stock: D. magna was bred by feeding on Chlorella vulgaris at the rate of 0.1–0.2 mg culture−1 day−1 Daphnia−1 at 21 ± 1 °C in the laboratory for more than 10 years.

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Nominal and measured concentrations:

control, 3, 4.4, 6.6, 10, and 15 mg/L (nominal)
control, 2.8, 4.0, 6.3, 9.8, and 14.6 mg/L (measured)

Details on test conditions:

TEST SYSTEM
- Test vessel:
Material, size, headspace, fill volume: 100 mL glass beakers filled with 50 mL test solution
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: M4 medium

OTHER TEST CONDITIONS
- Photoperiod: 16:8 light:dark cycle

EFFECT PARAMETERS MEASURED (with observation intervals if applicable): immobilisation after 24 h and 48 h

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

9.2 mg/L

Remarks on result:

other: 95% CL: 8.3-10 mg/L

Reported statistics and error estimates:

EC50 value and its 95% confidence limits were calculated by the probit analysis method by using Ky Prot version 4.

Validity criteria fulfilled:

not specified

Reference 5

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Version / remarks:

1984

GLP compliance:

no

Analytical monitoring:

no

Vehicle:

no

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Water flea
- Source: National Institute for Environmental Studies, Tsukuba, Japan
- Amount: 20 larvae (<24 hours old)

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Nominal and measured concentrations:

6 different concentrations

Details on test conditions:

TEST SYSTEM
- Test vessel: 50-mL beakers
- No. of organisms per vessel: 5

EFFECT PARAMETERS MEASURED (with observation intervals if applicable): immobilisation after 48 hours

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

1.9 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Reported statistics and error estimates:

EC50 determined using probit conversion analysis.

Validity criteria fulfilled:

not specified

Description of key information

LC50 (48h) = 9.2 mg/L for Daphnia magna (OECD 202, full test)

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

9.2 mg/L

Additional information

Public data is available on the short-term toxicity towards aquatic invertebrates. Most of the studies were conducted according to international guidelines but are not reported in as much detail as current reports according to GLP standards.

Five publications are available. The studies by Yamamoto et al. (2007a), Bazin et al. (2009), Dobbins et al. (2009) and Terasaki et al. (2008) were conducted according to OECD 202 guideline or an EPA standard using Daphnia magna as test organism. Testing period was 48 hrs and full tests were conducted.

The study by Li (2012) did not follow a standard protocol and used the planarian Dugesia japonica as test organism. Planarians were exposed for 48 h and 96 h to the test item and mortality was observed.

Since only in one study chemical analysis of the test item was conducted, this study was assessed as most reliable.  Therefore the EC50 of 9.2 mg/L determined in the study by Terasaki et al. (2008) is considered as key value.