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Long-term toxicity to fish

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Endpoint:
fish, juvenile growth test
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:
read-across source
Duration:
7 d
Dose descriptor:
LOEC
Effect conc.:
1.7 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Key result
Duration:
7 d
Dose descriptor:
NOEC
Effect conc.:
0.85 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Validity criteria fulfilled:
not specified
Conclusions:
In a 7-day toxictiy test with Pimephales promelas effecet concentrations for benzyl 4-hydroxybenzoate were determined as follows:
LOEC: 1.7 mg/L
NOEC: 0.85 mg/L
Executive summary:

The 7-day chronic toxicity of benzyl 4-hydroxy benzoate to early life stage of Pimephales promelas was studied under static renewal conditions.  24 h posthatch P. promelas larvae were exposed to control, and 1.7 / 0.85 / 0.43 / 0.22 / 0.11 a.i. mg/L. The test system was maintained at 25 ºC and a pH of 8.2 to 8.8. The 7-day LOEC, based on mortality and sublethal effects (weight) was 1.7 mg a.i./L respectively.   

This toxicity study is classified as acceptable and satisfies the guideline requirement for early life toxicity study with fish.

 

Results Synopsis

 

Test Organism Size/Age (mean wet weight or length): 24 h posthatch P. promelas larvae

Test Type (Flowthrough, Static, Static Renewal): Static renewal

 

LOEC: 1.7 mg/L

NOEC: 0.85 mg/L

Endpoint(s) Effected: mortality and weight

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

Endpoint:
adult fish: sub(lethal) effects
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting 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:
read-across source
Reference substance (positive control):
yes
Remarks:
0.1 µg/L 17β estradiol
Key result
Duration:
14 d
Dose descriptor:
NOEC
Effect conc.:
0.02 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: VTG concentration
Remarks on result:
other: male fish
Duration:
14 d
Dose descriptor:
LOEC
Effect conc.:
0.1 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: VTG concentration
Remarks on result:
other: male fish
Validity criteria fulfilled:
not specified
Conclusions:
In a VTG assay the VTG content in male medaka which were exposed for 14-d to benzyl 4-hydroxybenzoate was determined and statistically evaluated. A NOEC of 20 µg/L was determined.
Executive summary:

The long-term effects on medaka were assessed by a VTG assay with male medaka. 3-month-old male fish were exposed to benzyl 4-hydroxybenzoate for 14 days under static renewal conditions to control, positive control (0.1 µg/L 17β estradiol), and test chemical at nominal concentrations of 4, 20, 100, 500 µg a.i./L. In addition, female medaka was tested as well without exposure to the test substance. The test system was maintained at 25 ºC. The 14-day NOEC and LOCE values, based on VTG content were 20 and 100 µg a.i./L respectively.   

This toxicity study is classified as acceptable and satisfies the guideline requirement for early life toxicity study with fish.

 

Results Synopsis

 

Test Organism Size/Age (mean wet weight or length): 3-month-old male Oryzias latipes

Test Type (Flowthrough, Static, Static Renewal): Static renewal

LOEC:  20 µg/L a.i./L

NOEC:  100 µg a.i./L

Endpoint(s) Effected:  VTG content in male medaka

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

 

Description of key information

In a VTG assay the VTG content in male medaka which were exposed for 14-d to benzyl 4-hydroxybenzoate was determined and statistically evaluated. A NOEC of 20 µg/L was determined.

Key value for chemical safety assessment

EC10, LC10 or NOEC for freshwater fish:
20 µg/L

Additional information

Two studies are available on benzyl 4 -hydroxybenzoate:

In a 7-day toxictiy test with Pimephales promelas larvae which were exposed to benzyl 4-hydroxybenzoate effect concentrations

were determined as follows:

NOEC: 0.02 mg/L

LOEC: 0.10 mg/L

The NOEC from the VTG assay is used as key value for classification as it indicates longlasting effects on the fertility of male medaka.

As supporting information results from a VTG assay (14 -d exposure of male medaka) are available. The effect concentrations were determined as follows:

LOEC:  20 µg/L a.i./L

NOEC:  100 µg a.i./L