1H-Imidazole-5-methanol, 2-butyl-4-chloro-1-[[2'-(2H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-

Short-term toxicity to fish

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

Test material information

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 concentrations

Effect concentrations 1

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)

Effect concentrations 2

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.