Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline followed (with exceptions). Study well conducted and documented.
Cross-reference
Reason / purpose for cross-reference:
reference to other study

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
2007
Reference Type:
study report
Title:
Unnamed
Year:
2010

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: US EPA (1993): Methods for measuring the acute toxicity of effluents and receiving waters to freshwater organisms. Cincinnati, Ohio, U.S. Environmental Protection Agency.
Deviations:
yes
Remarks:
(1) Fathead minnows were 7-day old at onset of testing, (2) acclimated to the test medium for 7-days prior to testing, (3) were fed prior to and (4) at 48 hours during the test.
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
Lead dinitrate
EC Number:
233-245-9
EC Name:
Lead dinitrate
Cas Number:
10099-74-8
Details on test material:
- Name of test material (as cited in study report): Lead, PbNO3

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
- Concentrations: From each treatment

Test solutions

Vehicle:
no

Test organisms

Test organisms (species):
Pimephales promelas
Details on test organisms:
TEST ORGANISM
- Common name: Fathead minnow (FHM)
- Source: Aquatic BioSystem, Inc. (Fort Collins, CO, USA)
- Age at study initiation (mean and range, SD): 7 days
- Feeding during test: yes
- Food type: freshly hatched nauplii larvae
- Frequency: at 48h


ACCLIMATION
- Acclimation period: 1 week
- Acclimation conditions (same as test or not): acclimated to the test medium
- Type and amount of food: freshly hatched nauplii larvae
- Feeding frequency: once daily

Study design

Test type:
flow-through
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h

Test conditions

Hardness:
Hardness values ranged between 4.8 mg/L and 65.8 mg/L as CaCO3
See for details the table below.
Test temperature:
range: 17.5See for details the table below.
pH:
range: 5.35See for details the table below.
Nominal and measured concentrations:
pH Nominal Pb (µg/L) Measured Pb (µg/L)
5.35 0, 75, 150, 300, 600, 1200 0, 60, 71, 142, 427, 1109
5.67 0, 30, 60, 120, 240, 480 0, 14, 42, 88, 213, 438
6.34 0, 60, 120, 250, 500, 1000 0, 69, 148, 368, 507, 1207
6.71 0, 30, 60, 120, 240, 480 0, 16, 36, 77, 177,320
7.08 0, 2000, 4000, 6000, 8500, 12000, 17500, 25000 1, 2271, 5476, 7532, 9620, 12321, 17098, 13961
7.4 0, 500, 1000, 1500, 2000, 2500 0, 580, 969, 1548, 3012, 4154
7.46 0, 100, 250, 400, 550, 700 0, 103, 218, 303, 543, 661
7.47 0, 1000, 2500, 4000, 5500, 8000 0, 1019, 2318,3402, 6700, 8031
7.5 0, 50, 150, 300, 600, 1000 0, 58, 166, 310, 678, 1069
7.5 0, 100, 200, 400, 800, 1200 0, 86, 221, 412, 1003, 1723
7.51 0, 500, 1000, 2000, 3000, 4000 0, 231, 193, 1368, 2480, 3671
7.52 0, 100, 300, 500, 800, 1200 0, 145, 412, 767, 1127, 1929
7.55 0, 450, 900, 1350, 1800, 2400 0, 389, 791, 1123, 1586, 2460
7.55 0, 400, 800, 1200, 1600, 2000 0, 300, 779, 1101, 1610, 1993
7.58 0, 50, 100, 200, 400, 600 0, 49, 114, 249, 580, 901
7.59 0, 200, 400, 600, 900, 1200 0, 109, 353, 539, 961, 1252
7.6 0, 200, 400, 600, 800, 1000 0, 177, 360, 629, 832, 1158
7.61 0, 1000, 2000, 3000, 4000, 6000 0, 884, 2053, 3209, 4007, 6481
7.7 0, 500, 1000, 1500, 2000, 3000 0, 460, 936, 1693, 2781, 3438
7.85 0, 150, 300, 450, 900, 1400 0, 173, 340, 545, 1150, 1679
7.99 0, 500, 1000, 1500, 2000, 2500 0, 636, 1070, 1511, 1661, 1859
8.26 0, 300, 600, 900, 1200, 1600 0, 231, 450, 894, 1321, 1949
Details on test conditions:
TEST SYSTEM

Exposures were conducted under flow through conditions as outlined in Grosell et al (2006)
- Material, size, headspace, fill volume: polyethylene beakers
1 Primary mixing chamber: 30L (250ml/min)
6 Secondary mixing chambers: 4L each (30ml/min)
test chambers: 1L

Stock solutions of CaSO4, Aldrich humic acid (HA) or MOPS-KOH were added to the primary mixing chambers via Mariotte bottles or peristaltic pumps. Each primary mixing chamber fed test water via gravity to a total of six secondary mixing chambers at a constant rate of approximately 30ml/min. Lead stock solution was added to these secondary mixing chambers from Mariotte bottles.

- Aeration: yes
- Type of flow-through (e.g. peristaltic or proportional diluter): mariotte bottles or peristaltic pumps
- Renewal rate of test solution (frequency/flow rate): 6-8ml/min
- No. of fertilized eggs/embryos per vessel: 10 larval fathead minnows
- No. of vessels per concentration (replicates): 3

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: deionized water with dechlorinated Virginia Key tapwater (2:1).
See table below for more water parameters

- Intervals of water quality measurement: daily for the first three days of exposure, once-twice per week for the remaining exposure

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : mortality

Results and discussion

Effect concentrations
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
>= 40.79 - <= 3 597.95 µg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
dissolved
Basis for effect:
mortality (fish)
Remarks on result:
other: See the table below for details on the relation between water parametrs and LC50 values.
Reported statistics and error estimates:
Survival data was evaluated using ToxCalc TM version 5.0 (Tidepool Scentific, CA, US). LC50 was determined by linear regression.
In all cases, samples were considered statistically significantly different at P<0.05.

Any other information on results incl. tables

Sublethal observations / clinical signs:

Values of LC50 compared with the various water parameters:

pH Hardness Na+ K+ Ca2+ Mg2+ Cl- SO42- CO2 DOC T °C LC50 (µg/L)
5.67 15.9 165 7 101 58 429 25 n.d. 53 26 40.79
6.71 4.8 98 40 23 25 64 20 n.d. 105 26 68.17
5.35 27.8 716 12 218 60 1473 52 n.d. 134 19.8 162.3
7.58 18.5 519 24.5 131 54.1 431 40 182 79 22.7 178.1
6.34 28.7 561 10 226 61 903 41 n.d. 118 20.5 265.0
8.26 24.6 1050 10 186 60 577 48 n.d. 123 20 339.9
7.5 23.43 1361 28.9 165 69.3 1956 62 258 92 22.5 369.7
7.6 20 600 25.9 137 58.5 598 54 167 115 23.8 608.4
7.55 32.6 667 52 251 75 704 52 n.d. 182 26 622.4
7.5 29.7 579 10 234 63 415 43 n.d. 104 20.5 624.4
7.99 21.9 1353 32.6 149 69.6 592 42 1002 96 22.3 703.2
7.46 32 624 26 258 61.8 567 153 236 97 24.4 744.1
7.52 22.3 853 28 157 66.3 736 63 428 88 22.2 815.5
7.85 22.6 1089 28.4 160 66 722 63 744 91 22.1 995.7
7.55 51.5 643 25.1 445 70.1 590 334 202 94 23.6 1015
7.4 65.8 658 25.4 590 68.1 616 507 192 90 24.5 1068
7.59 21.4 605 25 154 60.1 606 52 185 138 24 1076
7.7 64.5 962 27.4 550 95 732 377 95 7.71 19 1148
7.51 21.5 616 25.6 152 62.6 609 52 176 216 24.9 1356
7.47 357 633 19.7 2950 61.7 462 2019   88 17.5 1719
7.6 20.9 630 26.1 148 60.9 618 55 248 420 24.6 3249
7.08 26 268 48 195 2 194 25 n.d. 1321 26 3598

Applicant's summary and conclusion

Conclusions:
Increasing DOC or hardness decreases the toxicity of lead in fish significantly due to a decrease of the bioavailability of the lead ion. Changing the concentrations of Na+, K+ or Mg2+ had no additional significant effect on toxicity expressed as the 96h-LC50 for fish. The lowest and the highest 96h-LC50 differed by almost three orders of magnitude (range: 40 - 3600 µg/L).
Executive summary:

In a study according to guideline US EPA (1993), 22 individual reliable acute toxicity data points for one specie Pimephales promelas were summarized in this data point:

After exposures were conducted under flow through conditions and for different pH and hardness values, the acute toxicity values (96h-LC50) for Pimephales promelas varied between of 40.8 µg dissolved Pb/L (at pH 5.67, hardness of 15.9 mg/L and a DOC of 53 mg/L) and 3598 µg dissolved Pb/L (at pH 7.1, hardness of 26 mg/L and a DOC of 1321 mg/L ).