reaction mass of Calcium chloride and Sodium chloride

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:

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

Adequacy of study:

weight of evidence

Study period:

no data

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Detailed description of testing procedure, no raw data, published in peer reviewed journal.

Justification for type of information:

See attached file

Reason / purpose for cross-reference:

data waiving: supporting information

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

GLP compliance:

no

Analytical monitoring:

yes

Details on sampling:

no data

Test organisms (species):

Daphnia magna

Details on test organisms:

Laboratory clones

Test type:

static

Water media type:

freshwater

Total exposure duration:

48 h

Remarks on exposure duration:

In the same publication exposures of 21 days were performed.

Post exposure observation period:

n.a.

Hardness:

45.3 mg/L

Test temperature:

18 +/- 1 °C

pH:

7.4-8.2

Dissolved oxygen:

measured at saturation

Salinity:

n.a.

Nominal and measured concentrations:

not specified (5-12) test concentrations depending on test material.

Details on test conditions:

TEST SYSTEM
- Test vessel: no data
- Type: open
- Material, size, headspace, fill volume: no data
- Aeration: no
- Type of flow-through (e.g. peristaltic or proportional diluter): static
- Renewal rate of test solution (frequency/flow rate): no renewal
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates):2
- No. of vessels per control (replicates): no data
- No. of vessels per vehicle control (replicates): no vehicle
- Biomass loading rate: no data

TEST MEDIUM / WATER PARAMETERS
Lake Superior water. Hardness and metal concentrations reported.

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 hr
- Light intensity: 115 ft-c

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :

TEST CONCENTRATIONS
- Spacing factor for test concentrations: no data
- Justification for using less concentrations than requested by guideline: 5 or more concentrations used
- Range finding study: no data
- Test concentrations: not specified
- Results used to determine the conditions for the definitive study:

Reference substance (positive control):

no

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

4 136 mg/L

Nominal / measured:

not specified

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: Reported as 1 640 000 µg/L of Na.

Details on results:

Two tests were performed. With and without feeding during exposure.
LC50 without feed: 4136 mg/L (reported as 1 630 000 µg/L of Na)
LC50 with feeding: 4590 mg/L (reported as 1 820 000 µg/L of Na).

Conclusions:

48 hr LC50 with Daphnia magna= 4136 mg/L

Executive summary:

Acute toxicity of NaCl to Daphnia magna was tested in a set-up similar to OECD guideline 202. The 48 hr LC50 with Daphnia magna is reported as 4136 mg/L. In the same article results from a study on reproduction and metabolism after 21 days of exposure of Daphnia magna are reported.

Reference 2

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

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

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Taken from OECD SIDS (OECD Guideline study)

Justification for type of information:

See attached file

Reason / purpose for cross-reference:

read-across: supporting information

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

GLP compliance:

yes

Analytical monitoring:

no

Vehicle:

not specified

Test organisms (species):

Daphnia magna

Details on test organisms:

Test Organisms: Daphnia magna, Crustacea
a) Age: 0-24 hours
b) Pretreatment: not described
c) Supplier/Source: Daphtoxkit F. magna from Bio International, The Netherlands

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

2 000 mg/L

Basis for effect:

mobility

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

2 400 mg/L

Basis for effect:

mobility

Table: Immobility of water fleas during the test
-----------------------------------------------------
  Nominal         Number of             Mean
  calcium         mobile water          immobility
  chloride        fleas (hours)         at test
concentration  ---------------------    termination
   (mg/l)       0      24       48      (%)
----------------------------------------------------

       0       10      10       10        0 
               10      10       10    
               10      10       10

    1000       10      10       10        0
               10      10       10
               10      10       10

    1400       10      10       10        0
               10      10       10
               10      10       10

    2000       10      10       10        3.3
               10      10       10
               10       9        9

    2800       10       0        0       93
               10       2        2
               10       0        0

    4000       10       0        0      100
                9       0        0
               10       0        0
------------------------------------------------------

- Table: Water parameters of test solution
------------------------------------------------------
  Nominal       Temperature       Oxygen        pH
  calcium          (°C)           content
  chloride                        (mg/l)
concentration
  (mg/l)
------------------------------------------------------
      0            20.0           8.4           8.2
   1000            19.9           8.7           8.3
   1400            19.9           8.5           8.2
   2000            19.9           8.5           7.9
   2800            19.8           8.5           7.8

Validity criteria fulfilled:

not specified

Conclusions:

The 96 hr LC50 of calcium chloride to the Daphnia magna was determined to be 2400 mg/L.

Executive summary:

The 96 hr LC50 of calcium chloride to the Daphnia magna was determined to be 2400 mg/L.

Reference 3

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

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

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Peer reviewed publication - no raw data presented.

Justification for type of information:

See attached file

Reason / purpose for cross-reference:

data waiving: supporting information

Qualifier:

equivalent or similar to guideline

Guideline:

other: Standard methods for the Examination of Water and Waste Water (APHA), Washington DC

GLP compliance:

no

Analytical monitoring:

no

Details on sampling:

no data

Test organisms (species):

Daphnia magna

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Hardness:

240 mg/l (without test material)

Test temperature:

11.5 to 14.5 °C - similar to the temperature of the pond from where the Daphnids were collected

pH:

7.2-7.8

Dissolved oxygen:

5.2 to 6.5 mg/l (begining of the study only)

Nominal and measured concentrations:

exposure concentrations not specified

Details on test conditions:

TEST SYSTEM
- Test vessel: 200 ml Beaker containing 100 ml of test solution
- Type (delete if not applicable): open
- Material, size, headspace, fill volume: 100 ml
- Aeration: no
- Type of flow-through (e.g. peristaltic or proportional diluter): static
- Renewal rate of test solution (frequency/flow rate): no renewal
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 3
- No. of vessels per control (replicates): not specified
- No. of vessels per vehicle control (replicates): not specified - no vehicle used.
- Biomass loading rate:

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: tubewell water filtered and aerated
- Total organic carbon: not specified
- Particulate matter: not specified
- Metals: not specified
- Pesticides: not specified
- Chlorine: 7 (5-10) mg/L
- Alkalinity: 400 (390 -415)
- Ca/mg ratio: 152 mg/l
- Conductivity: not specified
- Culture medium different from test medium: Water was taken from the pool where the Daphnia were collected from.
- Intervals of water quality measurement: begining of test. Begininig of test

OTHER TEST CONDITIONS
- Adjustment of pH: 7.2-7.8 not specified
- Photoperiod: not specified
- Light intensity:

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Lethality at 30 min 1,2,4,8,14, 24, 33, 48 h.

TEST CONCENTRATIONS
- Spacing factor for test concentrations: logarithmic
- Justification for using less concentrations than requested by guideline: n.a.
- Range finding study yes
- Test concentrations: not specified
- Results used to determine the conditions for the definitive study:

Reference substance (positive control):

no

Duration:

48

Dose descriptor:

EC50

Remarks:

complete immobilisation and no response to gentle agitation

Effect conc.:

874 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Remarks on result:

other: Effect concentration reported for Na only as 343.56 mg/L and adjusted to Na Cl by multiplying with (35.5+23)/23

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

874 mg/L

Nominal / measured:

not specified

Conc. based on:

test mat.

Basis for effect:

mortality

Reported statistics and error estimates:

EC50 and 95% cofidence intervals were calculated using the moving average-angle Method.

Conclusions:

While the study is not documented in significant detail, there is no reason to disregard this lowest value reported for acute toxicity to Daphnia magna

Executive summary:

In this study the toxicity of sodium chloride to Daphnia magna was tested together with a series of other metal salts to investigate correlation of the observed toxicity with relevant descriptors for the metals. The 48 hour toxicity of sodium chloride was reported in terms of the EC50 for immobilisation as 874 mg/l (as 343 mg/L Na+). No NOEC was reported and no raw data was presented that would allow conclusion on a NOEC.

Description of key information

The reaction mass contains c.a. 68% of calcium chloride and 30% of sodium chloride. The EC50 of the reaction mass was defined based on a worst case (i.e. the lowest EC50 of the two constituents was selected to reflect the EC50 of the reaction mass). Accordingly, the EC50 for aquatic invertebrates of the reaction mass of calcium chloride and sodium chloride is 1900 mg/L.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

1 900 mg/L

Additional information

No experimental data are available to assess the short-term toxicity of the reaction mass of calcium chloride and sodium chloride to aquatic invertebrates. Nevertheless, reliable information is available for calcium chloride (CaCl2) and sodium chloride (NaCl). The acute toxicity towards aquatic invertebrates of the constituents of the reaction mass (i.e. CaCl2 and NaCl) is known and the LD50 of the substance can thus be predicted. To this end, the key study assessing the acute toxicity of both compounds identified in the REACH registration dossier was selected.

Results from testing of acute toxicity to invertebrates of sodium chloride have been identified from a series of published studies. Preference has been given to studies which methodology followes or is similar to internationally accepted guidelines. With the exception of one study, the EC50 values for immobility are all > 3000 mg/L. The EC50 of sodium chloride for aquatic invertebrates was derived as the geometric mean of the two studies where animals were exposed for 48 hr: EC50 (Daphnia magna, 48 hr) = (874*4135)^(1/2) = 1900 mg/L. This value is well supported by other experimental data where animals were exposed for 24 hr.

For calcium chloride, seven acute toxicity data are available for Cladocera species. The reference value was selected as the EC50 orginating from the only study conducted according to international guidelines (OECD TG 202) on Daphnia magna following a 48 hr exposure period. Under the conditions of this study the 48-hour EC50 of 2,400 mg/L for Daphnia magna was obtained.

The reaction mass of calcium chloride and sodium chloride contains c.a. 68% of calcium chloride and 30% sodium chloride. The EC50 of the reaction mass was defined based on a worst case (i.e. the lowest EC50 of the two constituents was selected to reflect the EC50 of the reaction mass). Accordingly, the EC50 for aquatic invertebrates of the reaction mass of calcium chloride and sodium chloride is 1900 mg/L.