reaction mass of Calcium chloride and Sodium chloride

Long-term toxicity to fish

Link to relevant study record(s)

Reference

Endpoint:

fish early-life stage toxicity

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Study period:

1985

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study was non GLP, but followed good scientific practice. The report was detailed for a clear interpretation of the results.

Justification for type of information:

See attached document

Reason / purpose for cross-reference:

read-across: supporting information

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 210 (Fish, Early-Life Stage Toxicity Test)

GLP compliance:

no

Analytical monitoring:

yes

Details on sampling:

Water samples were collected from that portion of each test chamber located at the median depth of the water column.

Vehicle:

no

Test organisms (species):

Pimephales promelas

Details on test organisms:

Fathead minnows and eggs were obtained from the EPA Newton Fish Toxicology Laboratory, Cincinnati, Ohio.

Test type:

flow-through

Water media type:

freshwater

Limit test:

no

Total exposure duration:

33 d

Post exposure observation period:

none

Hardness:

Mean = 96.9 mg CaCO3/L
Standard deviation = 8.7 mg CaCO3/L

Test temperature:

Mean = 25.0 degrees C
Standard deviation = 0.3 degrees C

pH:

Mean = 7.5
Standard deviation = 0.22

Dissolved oxygen:

Mean = 7.6 mg/L
Standard deviation = 0.7 mg/L

Nominal and measured concentrations:

Nominal concentrations = Control, 0.25, 0.35, 0.50, 0.70, 1.0, 1.4 g/L
Measured concentrations = < 0.006 (Control), 0.252 g/L, 0.364 g/L, 0.533 g/L, 0.734 g/L, 1.057 g/L, 1.456 g/L

Details on test conditions:

TEST SYSTEM
- Test vessel: 500 ml Pyrex test vessel until hatch; 1 liter Pyrex test vessels after hatching
- Renewal rate of test solution (frequency/flow rate): 260 ml/hr; One volume addition every 2 hours
- No. of fertilized eggs/embryos per vessel: 35
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4

OTHER TEST CONDITIONS
- Photoperiod: 16 light: 8 dark

Exposure of fathead minnows was initiated 6 to 12 hours after fertilization and continued 28 days after hatching, giving a total exposure period of 33 days. Through hatching, exposure was maintained in 500-ml chambers. Feeding was initiated in the first day posthatching. For the first 9 days, larvae were fed live, newly-hatched brine shrimp four times per day at 4-h intervals. Beginning on the tenth day, the frequency of feeding was reduced to three times daily. Feeding was terminated 24-hours prior to the end of the experiment. the chambers were cleaned each day of accumulated debris by pipetting.

Organisms were observed daily and test conditions were monitored at about 3-day intervals.

Duration:

33 d

Dose descriptor:

NOEC

Effect conc.:

252 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

test mat.

Basis for effect:

mortality

Duration:

33 d

Dose descriptor:

LOEC

Effect conc.:

352 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

test mat.

Basis for effect:

mortality

Duration:

33 d

Dose descriptor:

NOEC

Effect conc.:

533 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

test mat.

Basis for effect:

length

Duration:

33 d

Dose descriptor:

LOEC

Effect conc.:

734 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

test mat.

Basis for effect:

length

Duration:

33 d

Dose descriptor:

NOEC

Effect conc.:

533 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

test mat.

Basis for effect:

weight

Duration:

33 d

Dose descriptor:

LOEC

Effect conc.:

734 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

test mat.

Basis for effect:

weight

Details on results:

Survival was assessed on Days 5, 9, 13, 17, 21, 25, 29, and 33. Average survival data at 33 days for nominal concentrations of control, 0.25, 0.35, 0.50, 0.70, 1.0, and 1.4 g/L were 94, 93, 86, 80, 66, 21, and 0%, respectively. Length and weight were also measured in this study, but these endpoints were not as sensitive as the survival endpoint.

Validity criteria fulfilled:

not applicable

Conclusions:

The 33 day NOEC and LOEC values for NaCl were 252 and 352 mg/L based on survival of early life stage fathead minnows.

Executive summary:

A 33 day early life stage toxicity test was conducted with fathead minnows (Pimephales promelas) and NaCl in a continuous flow-through system. The 33 day NOEC and LOEC values for NaCl were 252 and 352 mg/L based on survival of early life stage fathead minnows. Length and weight of the minnows were also measured in this study, but these endpoints were not as sensitive as the survival endpoint.

Description of key information

No experimental data are available to assess the long-term toxicity to fish of the reaction mass of calcium chloride and sodium chloride. No reliable information is avaliable for calcium chloride (CaCl2) but experimental studies have been conducted on sodium chloride (NaCl).

The 33-day NOEC value of 252 mg/L for sodium chloride, determined in a continuous flow-through exposure system with early life stage fathead minnows (Pimephales promelas), was selected as reflecting the long-term toxicity to fish of the reaction mass of calcium chloride and sodium chloride.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

252 mg/L

Additional information

No experimental data are available to assess the long-term toxicity of the reaction mass of calcium chloride and sodium chloride to fish. No reliable information is available for calcium chloride (CaCl2) but experimental studies have been conducted on sodium chloride.

In a non-GLP chronic freshwater fish study using fathead minnows (Klimisch score 2), six concentrations of sodium chloride (and controls) were delivered to early life stage fathead minnows in a continuous flow-through test system for 33 days. The 33-day NOEC and LOEC based on survival were 252 and 352 mg/L sodium chloride, respectively. The 33-day NOEC and LOEC for both length and weight were 533 and 734 mg/L sodium chloride, respectively. This study corresponds to the lowest NOEC value reported for sodium chloride, and this value was thus selected as the key value for this endpoint.

In addition, in accordance with the specific rules for adaptation of standard information requirement and with section 1 of Annex XI of the REACH regulation, a long-term toxicity study on fish does not need to be conducted if there are mitigating factors indicating that aquatic toxicity is unlikely to occur. The substance is a solution of inorganic salts (calcium chloride and sodium chloride) in water that are naturally occurring in aquatic ecosystems. In the aquatic environment, calcium chloride and sodium chloride will dissociate to form calcium, sodium and chloride ions. These ions are ubiquitous in the environment, they are essential constituents to all living organisms and they have been measured extensively in aquatic ecosystems. Sodium and chloride ions originate from natural weathering of rock, from atmospheric transport of oceanic inputs and from a wide variety of anthropogenic sources. Calcium is the most common cation found in surface water. In 1995, a global water quality monitoring was conducted in North America, South-America, Asia, Africa, Europe and Oceania (UNEP, 1995). The mean, 10th-percentile and 90th-percentile of calcium concentrations in 76 rivers were 37.4, 5.1 and 86.5 mg/L, respectively. For waters associated with carbonate-rich rocks, concentrations may reach 30-100 mg.L-1. The mean, 10th-percentile and 90th-percentile of chloride concentrations in 77 rivers were 41.1, 1.1 and 64.8 mg/L, respectively. The mean, 10th-percentile and 90th-percentile of sodium concentrations in 76 rivers were 37.4, 5.1 and 86.5 mg/L, respectively. Based on these data and the composition of the substance, it is evident that aquatic organisms are tolerant to the substance in the 10-100 mg/L range.

Based on the above, the NOEC of sodium chloride (i.e. 252 mg/L) was selected as appropriately reflecting the long-term toxicity to fish of the reaction mass.