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Ecotoxicological information

Short-term toxicity to fish

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Endpoint:
short-term toxicity to fish
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Remarks:
Data is published in peer reviewed journal
Justification for type of information:
The source compound Benzyl 4-hydroxybenzoate (EC 202-311-9, CAS 94-18-8) is considered a suitable read across partner for the target substance Phenyl 4-hydroxybenzoate (EC 241-698-9, CAS 17696-62-7). This read-across is based on the hypothesis that source and target substances have similar toxicological properties because:

- structural similarity of the target and the source substances (the presence or absence of additional functional groups or substituents that could influence the behaviour of a chemical),
- similarity in physico-chemical profile of the source and target substances (water solubility, partitioning behaviour (log Kow value))
Both substances are structural homologues regarding the functional groups at the ester (phenyl vs benzyl group). Both esthers have similar physico-chemical properties. Both are moderately/poorly water soluble (108 g/L vs 0.05 mg/L), exhibit similar log Kow values (3.97 vs 3.21), have similar boiling points (355 °C vs 241 °C) and vapour pressure (3.37x10-6 mm Hg vs 8.17x10-6 mm Hg).
Reason / purpose for cross-reference:
read-across source
Qualifier:
according to guideline
Guideline:
other: as per mentioned below
Principles of method if other than guideline:
Pimephales promelas were exposed to benzyl 4-hydroxybenzoate in different concentrations. For each concentration, two replicates of 10 P. promelas in 250 mL of test solution were exposed in 500 mL beakers without food for 48 h. Mortality was
documented at 24 and 48 h. The LC50 was calculated for each exposure.
GLP compliance:
no
Specific details on test material used for the study:
TEST MATERIAL
- Name of test material (as cited in study report): Benzylparaben
(Synonyms of Benzoic acid, 4-hydroxy-, phenyl methyl ester)
- Molecular formula (if other than submission substance): C14-H12-O3
- Molecular weight (if other than submission substance): 228.2458 g/mol
- Smiles notation (if other than submission substance): c1ccc(cc1)COC(=O)c2ccc(cc2)O
- InChl (if other than submission substance): 1S/C14H12O3/c15-13-8-6-12(7-9-13)14(16)17-10-11-4-2-1-3-5-11/h1-9,15H,10H2
- Substance type: Organic
- Physical state: Solid
- Analytical purity: 99%
Analytical monitoring:
not specified
Vehicle:
yes
Remarks:
acetone
Details on test solutions:
To make test solutions, parabens were dissolved in high-performance liquid chromatography grade acetone and delivered into RHW at 0.1% acetone.
Test organisms (species):
Pimephales promelas
Details on test organisms:
TEST ORGANISM
- Common name: Fathead minnow
- Age at study initiation (mean and range, SD): 24 h post hatch
- Feeding during test : no food provided during test
Test type:
static
Water media type:
freshwater
Total exposure duration:
48 h
Hardness:
160 to 175 mg/L as CaCO3
Test temperature:
24°C
pH:
8.2 to 8.8
Dissolved oxygen:
dissolved oxygen of water =7.1 to 9.0 mg/L
Nominal and measured concentrations:
Five concentrations mentioned but not specified.
Details on test conditions:
TEST SYSTEM
- Test vessel: Beakers
- Material, size, headspace, fill volume:250 mL
- Aeration: No aeration provided
- No. of vessels per concentration (replicates): 2 replicates

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: test material was dissolved in high-performance liquid chromatography grade acetone and delivered into RHW at 0.1% acetone.
- Alkalinity: 110 to 120 mg/L as CaCO3

OTHER TEST CONDITIONS
- Adjustment of pH: 8.2 to 8.8
- Photoperiod: 16:8 light: dark cycle

TEST CONCENTRATION
- Test concentrations: five concentration mentioned but values are not specified
Reference substance (positive control):
not specified
Key result
Duration:
48 h
Dose descriptor:
LC50
Effect conc.:
3.3 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: 5 nominal concentrations were used but exact values are not reported.
Validity criteria fulfilled:
not specified
Conclusions:
The 48 hLC 50 value for Pimephales promelas for benzl 4-hydroxybenzoate (CAS # 94-18-8) was determined with 3.3 mg/L concentrations.
Executive summary:

Short-term toxicity to Pimephales promelas was performed for 48 hrs at five nominal concentrations in a temperature-controlled incubator at 24 °C with a 16:8 light: dark cycle. 500 mL beaker was taken having 250 mL of test chemical. Test solution was prepared by dissolved in high-performance liquid chromatography grade acetone and delivered into RHW at 0.1 % acetone. No aeration was used and LD50 value was determined at 24 and 48 hrs.

The LC50 value for Pimephales promelas was found determined with 3.3 mg/L.

Endpoint:
short-term toxicity to fish
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
The source compound Benzyl 4-hydroxybenzoate (EC 202-311-9, CAS 94-18-8) is considered a suitable read across partner for the target substance Phenyl 4-hydroxybenzoate (EC 241-698-9, CAS 17696-62-7). This read-across is based on the hypothesis that source and target substances have similar toxicological properties because:

- structural similarity of the target and the source substances (the presence or absence of additional functional groups or substituents that could influence the behaviour of a chemical),
- similarity in physico-chemical profile of the source and target substances (water solubility, partitioning behaviour (log Kow value))
Both substances are structural homologues regarding the functional groups at the ester (phenyl vs benzyl group). Both esthers have similar physico-chemical properties. Both are moderately/poorly water soluble (108 g/L vs 0.05 mg/L), exhibit similar log Kow values (3.97 vs 3.21), have similar boiling points (355 °C vs 241 °C) and vapour pressure (3.37x10-6 mm Hg vs 8.17x10-6 mm Hg).
Reason / purpose for cross-reference:
read-across source
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
0.73 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: Five concentration mention but not specified values
Reported statistics and error estimates:
Ecotox-Statistics software ver. 2.6 were used to conduct probit or logit conversion analysis
Validity criteria fulfilled:
not specified
Conclusions:
The LC 50 value for benzyl 4-hydroxybenzoate (CAS # 94-18-8) to fish was determined as 0.73 mg/L.
Executive summary:

In a 96-h acute toxicity study, japanese medaka (Oryzias latipes) were exposed to benzyl 4-hydroxybenzoate at five different concentrations (range not reported) under static conditions and in accordance of OECD guideline 203. 10 fishes (age: 10 days) were exposed to the test substance in five 100 mL-beaker. Half of the paraben solution was replaced every 24 h.

The LC50 value, based on mortality was determined with 0.73 mg/L. Based on the results of this study, benzyl 4-hydroxybenzoate would be classified as Aquatic Acute 1 to japanese medaka in accordance with the CLP classification system.

 

Results Synopsis

 

Test organism size/age: Oryzias latipes (ca. 10 d old)

Test Type: semi-static

 

96 h LC50 = 0.73 mg/L

Endpoint(s) Effected: mortality

This information is used in a read-across approach in the assessment of the target substance.

Description of key information

The key value was determined as 96 h LC50 for Oryzias latipas equalling 0.73 mg/L.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Effect concentration:
0.73 mg/L

Additional information

Two studies are available for short-term toxicity on fish. Both experiments are published in peer reviewed scientific journals and conducted according or similar to the OECD guideline 203.

The key study from Yamamoto et al. revealed a 96 h LC50 for Oryzias latipes. In the exposure experiment from Dobbins et al. (2009) a 48 h LC 50 of 3.3 mg/L was determined for Pimephales promelas, which is in the same range as the LC50 derived by Yamamoto et al.: 96 -h LC50 = 0.73 mg/L. The lower value was set as key value.