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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
January 28 to February 1, 1993
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Study conducted according to GLP and well document methods. Although the study was conducted according to GLP and well documented methods, " Practical guide 10: How to avoid unnecessary testing on animals", Section 3.3.2 states it is important that the reliability indicator (Klimisch score) reflects the assumptions of similarity. Thus, a score of 1 (reliable without restrictions) should normally not be used for results derived from read-across.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report date:
1993

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
other: US FDA Technical Assistance Document 4.11, 1987
Principles of method if other than guideline:
Doses (measured): control, 120, 200, 333, 555, 929 mg/L
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Losartan potassium (MK0954)
IUPAC Name:
Losartan potassium (MK0954)
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Specific details on test material used for the study:
Details on properties of test surrogate or analogue material (migrated information):
- Name of test material (as cited in study report): Losartan
- Substance type: white powder
- Physical state: solid
- Analytical purity: 99.8% and 100.4%

- Lot/batch No.: L-158086-005H035 AND E3340-45

Test organisms

Test organisms (species):
Oncorhynchus mykiss (previous name: Salmo gairdneri)
Details on test organisms:
TEST ORGANISM
- Common name: rainbow trout
- Source: Stoney Creek Trout Farm, Grant, Michigan
- Age at study initiation (mean and range, SD): Juveniles
- Length at study initiation (length definition, mean, range and SD): 33 +/- 2.0 mm
- Weight at study initiation (mean and range, SD):0.47 +/- 0.09g
- Method of breeding:
- Feeding during test
- Food type:
- Amount:
- Frequency:

ACCLIMATION
- Acclimation period:
- Acclimation conditions (same as test or not):
- Type and amount of food:
- Feeding frequency:
- Health during acclimation (any mortality observed):

QUARANTINE (wild caught)
- Duration:
- Health/mortality:

Study design

Test type:
static
Water media type:
freshwater
Total exposure duration:
96 h

Test conditions

Hardness:
64 mg/L as CaCo3
Test temperature:
11.0 to 11.4 degrees C

Results and discussion

Effect concentrationsopen allclose all
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 929 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
929 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mortality (fish)

Applicant's summary and conclusion

Conclusions:
The 96-hr LC50 based on mean measured Losartan Potassium (MK0954) concentrations was >929 mg/L. The NOEC was 929mg/L based upon the lack of mortality or observed sublethal effects at this test concentration. Therefore, by read-across, the NOEC and LC50 for losartan free acid are >>> solubility.