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Diss Factsheets

Ecotoxicological information

Long-term toxicity to aquatic invertebrates

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Endpoint:
long-term toxicity to aquatic invertebrates
Type of information:
other: review
Adequacy of study:
key study
Study period:
21 days
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Remarks:
Review of available data. Methodologcial data for individual studies are incomplete, however the studies have been assessed as part of the EU RAR and are therefore considered to be suitably reliable.
Qualifier:
no guideline followed
Principles of method if other than guideline:
The publication is a review article of various studies using a number of different methods.
GLP compliance:
no
Specific details on test material used for the study:
Not applicable.
Analytical monitoring:
not specified
Details on sampling:
No details of sampling in review article.
Vehicle:
not specified
Details on test solutions:
No details on test solutions in review.
Test organisms (species):
Daphnia magna
Details on test organisms:
No details on test organisms in the review.
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
21 d
Post exposure observation period:
No post exposure observation period.
Hardness:
250 mg CaCO3/L
Test temperature:
Not stated
pH:
Not stated
Dissolved oxygen:
Not stated
Salinity:
Not stated
Nominal and measured concentrations:
In one test the concentrations were measured. In all others a nominal concentration is given.
Details on test conditions:
No further details on test conditions.
Reference substance (positive control):
not specified
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
3.7 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
reproduction
Remarks on result:
other: (Janssen et al., 1989)
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
14.1 mg/L
Nominal / measured:
meas. (initial)
Conc. based on:
test mat.
Basis for effect:
reproduction
Remarks on result:
other: (Kühn et al., 1988)
Key result
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
8.9 mg/L
Nominal / measured:
not specified
Conc. based on:
test mat.
Basis for effect:
reproduction
Remarks on result:
other: Arithmetic mean calculated from the NOEC values from both tests (above), as reported in the EU RAR (2001)
Details on results:
In both long-term tests with daphnids the NOEC is based on effects on reproduction. The arithmetric mean of both tests gives a value of 8.9 mg/L for the NOEC.
Results with reference substance (positive control):
Not applicable
Reported statistics and error estimates:
No reported statistics and error estimates.

The NOEC values for long-term toxicity to daphnids were 3.7 and 14.1 mg F-/L after 21 d of exposure, based on effects on reproduction, but exposure concentrations were analytically confirmed only in the study that gave the higher endpoint. The arithmetric mean of both endpoints is a NOEC of 8.9 mg F-/L.

Validity criteria fulfilled:
not specified
Conclusions:
The 21-day NOEC for D. magna exposed to sodium fluoride ranged between 3.7 and 14.1 mg F-/L. The arithmetic mean value was 8.9 mg F-/L. .
Executive summary:

The EU RAR summarises the findings of two long-term toxicity studies with D. magna exposed to sodium fluoride. The two studies provide reproductive NOEC values of 3.7 and 14.1 mg F-/L and the arithmetic mean NOEC is 8.9 mg F-/L.

Endpoint:
long-term toxicity to aquatic invertebrates
Type of information:
other: review
Adequacy of study:
supporting study
Study period:
Not reported
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Remarks:
The ICD reviews the available data on the long-term toxicity of fluorides to aquaric invertebrates
Qualifier:
no guideline followed
Principles of method if other than guideline:
The ICD reviews the available data on the long-term toxicity of fluorides to aquaric invertebrates
GLP compliance:
no
Test organisms (species):
other: various
Dose descriptor:
EC50
Effect conc.:
10 - 48 mg/L
Remarks on result:
other: Freshwater invertebrates

EC50 values of 10-48 mg/L are reported for freshwater invertebrates

Validity criteria fulfilled:
not specified
Conclusions:
EC50 values of 10-48 mg/L are reported for freshwater invertebrates.
Executive summary:

The ICD reviews the available data on the long-term toxicity of fluorides to aquaric invertebrates and reports EC50 values of 10-48 mg/L. No long-term toxicity studies were available for marine invertebrates.

Endpoint:
long-term toxicity to aquatic invertebrates
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
It is considered appropriate to address the long-term toxicity to aquatic invertebrates data requirement for hydrogen fluoride (HF) by read-across to available data on sodium fluoride (NaF).

In water, HF (as hydrofluoric acid when in water) dissociates rapidly to form hydrogen (H+) and fluoride (F−) ions, whereas NaF (the highly soluble sodium salt of fluoride) will be fully hydrated in water as separate sodium (Na+) and F- ions. Both HF and NaF (as well as other fluorides) will therefore dissociate rapidly to form F- ions in the aquatic environment, with any effects observed being directly attributable to the F- ion. The Na+ ion is naturally occurring and regulated by organisms (i.e. by homeostatic mechanisms) and consequently is not considered to have an impact on the read-across of ecotoxicological data. On this basis, the profile of HF is comparable to that of NaF with respect to the environment.
Reason / purpose for cross-reference:
read-across source
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
3.7 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
reproduction
Remarks on result:
other: (Janssen et al., 1989)
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
14.1 mg/L
Nominal / measured:
meas. (initial)
Conc. based on:
test mat.
Basis for effect:
reproduction
Remarks on result:
other: (Kühn et al., 1988)
Key result
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
8.9 mg/L
Nominal / measured:
not specified
Conc. based on:
test mat.
Basis for effect:
reproduction
Remarks on result:
other: Arithmetic mean calculated from the NOEC values from both tests (above), as reported in the EU RAR (2001)
Details on results:
In both long-term tests with daphnids the NOEC is based on effects on reproduction. The arithmetric mean of both tests gives a value of 8.9 mg/L for the NOEC.
Results with reference substance (positive control):
Not applicable
Reported statistics and error estimates:
No reported statistics and error estimates.

The NOEC values for long-term toxicity to daphnids were 3.7 and 14.1 mg F-/L after 21 d of exposure, based on effects on reproduction, but exposure concentrations were analytically confirmed only in the study that gave the higher endpoint. The arithmetric mean of both endpoints is a NOEC of 8.9 mg F-/L.

Validity criteria fulfilled:
not specified
Conclusions:
The 21-day NOEC for D. magna exposed to sodium fluoride ranged between 3.7 and 14.1 mg F-/L. The arithmetic mean value was 8.9 mg F-/L. .
Executive summary:

It is considered appropriate to address the long-term toxicity to aquatic invertebrates data requirement for hydrogen fluoride (HF) by read-across to available data on sodium fluoride (NaF). In water, HF (as hydrofluoric acid when in water) dissociates rapidly to form hydrogen (H+) and fluoride (F) ions, whereas NaF (the highly soluble sodium salt of fluoride) will be fully hydrated in water as separate sodium (Na+) and F- ions. Both HF and NaF (as well as other fluorides) will therefore dissociate rapidly to form F- ions in the aquatic environment, with any effects observed being directly attributable to the F- ion. The Na+ ion is naturally occurring and regulated by organisms (i.e. by homeostatic mechanisms) and consequently is not considered to have an impact on the read-across of ecotoxicological data. On this basis, the profile of HF is comparable to that of NaF with respect to the environment.

The EU RAR summarises the findings of two long-term toxicity studies with D. magna exposed to sodium fluoride. The two studies provide reproductive NOEC values of 3.7 and 14.1 mg F-/L and the arithmetic mean NOEC is 8.9 mg F-/L.

Endpoint:
long-term toxicity to aquatic invertebrates
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Justification for type of information:
It is considered appropriate to address the long-term toxicity to aquatic invertebrates data requirement for hydrogen fluoride (HF) by read-across to available data on sodium fluoride (NaF).

In water, HF (as hydrofluoric acid when in water) dissociates rapidly to form hydrogen (H+) and fluoride (F−) ions, whereas NaF (the highly soluble sodium salt of fluoride) will be fully hydrated in water as separate sodium (Na+) and F- ions. Both HF and NaF (as well as other fluorides) will therefore dissociate rapidly to form F- ions in the aquatic environment, with any effects observed being directly attributable to the F- ion. The Na+ ion is naturally occurring and regulated by organisms (i.e. by homeostatic mechanisms) and consequently is not considered to have an impact on the read-across of ecotoxicological data. On this basis, the profile of HF is comparable to that of NaF with respect to the environment.
Dose descriptor:
EC50
Effect conc.:
10 - 48 mg/L
Remarks on result:
other: Freshwater invertebrates

EC50 values of 10-48 mg/L are reported for freshwater invertebrates

Validity criteria fulfilled:
not specified
Conclusions:
EC50 values of 10-48 mg/L are reported for freshwater invertebrates.
Executive summary:

It is considered appropriate to address the long-term toxicity to aquatic invertebrates data requirement for hydrogen fluoride (HF) by read-across to available data on sodium fluoride (NaF). In water, HF (as hydrofluoric acid when in water) dissociates rapidly to form hydrogen (H+) and fluoride (F) ions, whereas NaF (the highly soluble sodium salt of fluoride) will be fully hydrated in water as separate sodium (Na+) and F- ions. Both HF and NaF (as well as other fluorides) will therefore dissociate rapidly to form F- ions in the aquatic environment, with any effects observed being directly attributable to the F- ion. The Na+ ion is naturally occurring and regulated by organisms (i.e. by homeostatic mechanisms) and consequently is not considered to have an impact on the read-across of ecotoxicological data. On this basis, the profile of HF is comparable to that of NaF with respect to the environment.

The ICD reviews the available data on the long-term toxicity of fluorides to aquaric invertebrates and reports EC50 values of 10-48 mg/L. No long-term toxicity studies were available for marine invertebrates.

Description of key information

The EU RAR summarises the effects of two reproductive studies of sodium fluoride on Daphnia magna. The two studies report NOEC values of 3.7 and 14.1 mg/L, with an arithmetic mean of 8.9 mg/L.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates
Dose descriptor:
NOEC
Effect concentration:
8.9 mg/L

Additional information

The EU RAR summarises the effects of two reproductive studies of sodium fluoride on Daphnia magna. The two studies report NOEC values of 3.7 and 14.1 mg/L, with an arithmetic mean of 8.9 mg/L. The ICD reports additional EC50 values in the range of 10 - 48 mg/L.