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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Ecotoxicological information

Short-term toxicity to fish

Currently viewing:

Administrative data

Link to relevant study record(s)

Reference
Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to a protocol similar to OECD 203 with GLP, however no analytical monitoring was carried out.
Qualifier:
according to guideline
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
Deviations:
yes
Remarks:
lacks analytical monitoring and a range finding test
GLP compliance:
yes
Analytical monitoring:
no
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION

- Method: direct addition of test material to obtain each nominal concentration

- Evidence of undissolved material (e.g. precipitate, surface film, etc): none reported
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM

- Source: Incontri con la natura,Cirie, Italy

- Length at study initiation (mean): 2.3 cm

- Weight at study initiation (mean): 0.345 g

- Method of breeding: not reported

- Feeding during test: no


ACCLIMATION

- Acclimation period: 2 months

- Acclimation conditions (same as test or not): same dilution water

- Type and amount of food: Mangime Principale JBL-JBL GmbH batch 301307 until 24 hours before start of the study

- Feeding frequency: daily

- Health during acclimation (any mortality observed): 0% after 7 days of acclimation
Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Hardness:
40 mg/L as CaCO3 (dilution water)
Test temperature:
20⁰C
pH:
range: 6.8 to 7.6 in the controls and 7.4 to 8.5 in exposure vessels. The pH decreased with time.
Dissolved oxygen:
range: 8.0 to 9.0 mg/l
Nominal and measured concentrations:
Nominal concentrations test substance: 0, 1000, 1200, 1440, 1728 and 2074 mg/l. (Equivalent to:
Nominal concentrations ATMP n oxide xK [43%]: 0, 430, 515, 620, 745 and 890 mg/L
Nominal concentration ATMP n oxide acid [27%]: 0, 270, 325, 390, 465 and 560 mg/L)
Details on test conditions:
TEST SYSTEM

- Test vessel: tanks

- Material, size, fill volume: plastic, 30x36x24 cm filled with 10 L dilution water

- Aeration: not reported

- Renewal rate of test solution (frequency): 24 hours

- No. of organisms per vessel: 10

- No. of vessels per concentration (replicates): 1

- No. of vessels per control (replicates): 1

- Biomass loading rate: ca. 0.345 g/L


TEST MEDIUM / WATER PARAMETERS

- Source/preparation of dilution water: from the municipal main water system

- Metals and Pesticides: within the acceptance limits of water quality defined in EEC Directive 80/778

- Culture medium different from test medium: no

- Intervals of water quality measurement: daily

OTHER TEST CONDITIONS

- Adjustment of pH: the pH was adjusted at the start of the study in vessels to pH 6-8.5 with 37% HCl solution.

- Photoperiod: 12 to 16 hours light

- Light intensity: not reported


EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : mortality was measured every 24 hours from the start of the study. Behavioural of physiological abnormalities were also recorded at the same time.


TEST CONCENTRATIONS

- Spacing factor for test concentrations: 1.2

- Range finding study: not conducted
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
1 152 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
495 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Remarks:
active salt
Basis for effect:
mortality (fish)
Remarks on result:
other: Calculated by reviewer
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
310 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Remarks:
active acid
Basis for effect:
mortality (fish)
Remarks on result:
other: Calculated by reviewer
Details on results:
- Behavioural abnormalities: none observed

- Abnormal responses: none observed

- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: none

- Effect concentrations exceeding solubility of substance in test medium: no
Reported statistics and error estimates:
No details reported. LC50 values as active acid and active salt have been calculated by the reviewer from the reported LC50 value of the test material of 1152 mg/L.
Sublethal observations / clinical signs:

Table 1. Cumulative mortality results.

 Nominal concentrations TS (mg/L)  # dead animals
24 h   48 h  72 h  96 h  % mortality
 Control  0  0  0  0  0
 1000  1  1  1  1  10
 1200  0  0  2  5  50
 1440  2  4  6  7  70
 1728  1  5  7  8  80
 2074  5  6  8  9  90
Validity criteria fulfilled:
yes
Conclusions:
96 h LC50 values of 495 mg active salt/L, and 310 mg active acid/L (as calculated by the reviewer), have been determined for the effects of the test substance on the mortality of the freshwater fish Brachydanio rerio. Although 100% mortality was not recorded, it was possible to derive an LC50.

Description of key information

96 h LC50 310 mg active acid/L, Brachdanio rerio, (reliability 2, RBM 1991)

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Effect concentration:
310 mg/L

Additional information

A 96 h LC50 value of 495 mg active salt/L, and 310 mg active acid/L, has been determined for the effects of the test substance on the mortality of the freshwater fish Brachydanio rerio (RBM 1991). Although 100% mortality was not recorded, it was possible to derive an LC50. The study was conducted according to EC test method C.1, however no analytical monitoring was carried out. This is the only study available with the substance and has been selected as key.