Salicylamide

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

June 8th to 12th, 1982

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Valid and conclusive study comparable to guideline in the context of a U.S. national ecotoxicological screening program (Structure-Activity Research Program)

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

no

GLP compliance:

yes

Remarks:

it is assumed that usual U.S. EPA Laboratory Quality Assurance measures were applied

Analytical monitoring:

yes

Details on sampling:

- Concentrations: Analytical dose verification performed in all concentrations and the control

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: The test solutions were constantly prepared by dilution of stock solutions in a flow-through system.

Test organisms (species):

Pimephales promelas

Details on test organisms:

TEST ORGANISM
- Common name: Fathead minnow
- Source: Laboratory cultured animals were used
- Age at study initiation: 34 days
- Weight at study initiation: 0.29 g
- Method of breeding: 25 °C flow water; 16 light period; fed with frozen adult brine shrinp (Artemia salina); asbestos pipes (cut in half longitudinally) as spawning substrates, which were ermoved daily for hatchig; larvae reared in water same to and a system similar to exposure at 25 °C and fed 40-48 h old brine shrimp larvae two times daily in excess.
- Feeding during test: No

Test type:

flow-through

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Hardness:

41.2±0.45 mg/L as CaCO3

Test temperature:

25.3±0.32 °C, bases on daily averages monitored with a recording Thermometer

pH:

7.48±0.48

Dissolved oxygen:

6.4 mg/L measured using a oxygen sensitive electrode, model 54 polarograph from Yellow Springs Instrument, OH 45387, U.S.A.

Nominal and measured concentrations:

Average measured concentrations were <3.5 (control), 40.7, 61.1, 89.3, 133, and 199 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: Glass jars with a fill volume of 2.0 L
- Aeration: No
- Type of flow-through: proportional diluter
- Renewal rate of test solution: 18 chamber volumes were added per day
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates): 2
- Biomass loading rate: 0.145 g/L

TEST MEDIUM / WATER PARAMETERS
- Alkalinity in the test chambers: 41.4±0.80 mg/L as CaCO3
- Source/preparation of dilution water: The dilution water originated from Lake Superior (WI, U.S.A.) and was sand filtered before use.
- Particulate matter: <1 mg/L
- Metals:
Sodium 1.1-1.2 mg/L
Calcium 13.0-14.7 mg/L
Magnesium2.9-3.6 mg/L
Potassium 0.48-0.59 mg/L
Aluminum 1-26 µg/L
Cadmium <0.1 µg/L
Chromium 2-20 µg/L
Cobalt <0.5 µg/L
Copper 0.3-3.2 µg/L
Iron 2-83 µg/L
Lead 7-20 µg/L
Manganese 0.2-11.5 µg/L
Nickel <0.5 µg/L
Zinc 1.0-2.7 µg/L
- Chlorine: 1.2-1.3 mg/L
- Ca/Mg ratio: About 4 to 4.5 (weight basis)
- Conductivity: 78-86 µmhos/cm
- Culture medium different from test medium: No
- Intervals of water quality measurement: Temperature constantly monitored; other parameters once in all concentrations and control chambers

OTHER TEST CONDITIONS
- Adjustment of pH: Generally the pH in the stock solutions was adjusted to 7.8 if outside the range from 7 to 8 using NaOH or HCl. Based on the experimental pKa of 8.37 at 20 °C (U.S. Library of Medicine, ChemIDplus) it is assumed that such adjustment was not required for Salicylamide.
- Photoperiod: 16 h
- Light intensity: Illumination by fluorescent tubes producing 28-48 limens at water surface

EFFECT PARAMETERS MEASURED:
The mortality was daily recorded.

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 1.46 to 1.5

Reference substance (positive control):

not required

Remarks:

as the fish were exposed to numerous substances in the screening program

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

101 mg/L

Nominal / measured:

meas. (TWA)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: 95% CL: 94.0 to 108

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

61.1 mg/L

Nominal / measured:

meas. (TWA)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: No sublethal effect data recorded

Duration:

96 h

Dose descriptor:

LOEC

Effect conc.:

89.3 mg/L

Nominal / measured:

meas. (TWA)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: No sublethal effect data recorded

Duration:

72 h

Dose descriptor:

NOEC

Effect conc.:

91.7 mg/L

Nominal / measured:

meas. (TWA)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: No sublethal effect data recorded

Duration:

72 h

Dose descriptor:

LOEC

Effect conc.:

133 mg/L

Nominal / measured:

meas. (TWA)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: No sublethal effect data recorded

Details on results:

- Behavioural abnormalities: Affected fish showed hyperactivity and lost equilibrium prior to death
- Mortality of control: No

Reported statistics and error estimates:

The trimmed Spearman-Karber Method was used to estimate the LC50 and its 95% CL.
-Hamilton MA, Russo RC &Thurston RV (1977). Trimmed Spearman-Karber method for estimating median lethal concentrations in toxicity bioassays. Environ Sci Technol 11:714-719; Correction 12:417 (1978)

Sublethal observations / clinical signs:

Table 1: Concentration of Salicylamide in the flow through test media

Date (exposure duration)	Measured Salicylamide Concentrations
	Control	A	B	C	D	E
8 June 1982 (0 h)	<3.5	38.2	61.8	86.8	134	205
9 June 1982 (24 h)	<2.7	39.4	58.2	97.3	146	214
10 June 1982 (48 h)	<3.4	46.0	65.2	85.9	130	195
11 June 1982 (72 h)	<4.8	43.6	65.6	96.6	135	204
Average (TWA)	<3.6	41.8	62.7	91.7	136	205
Corrected *	<3.5	40.7	61.1	89.3	133	199

* based on recovery rate

No nominal concentrations were reported

At 96 h no sample was taken

 

Table 2: Mortalities

Exposure duration [h]	Mortalities among 20 fish in the Test chambers
	Control	A	B	C	D	E
24	0	0	0	0	5	20
48	0	0	0	0	14	20
72	0	0	0	0	19	20
96	0	0	0	4	20	20

 

Validity criteria fulfilled:

yes

Remarks:

as OECD 203 criteria were met

Conclusions:

Salicylamide was not acute toxic under the conditions of the test and exhibited a LC50 of 101 mg/L

Executive summary:

The acute toxicity of Salicylamide (CAS 65-45-2) to fathead minnows (Pimephales promelas) was evaluated in the context of a U.S. national ecotoxicological screening program (Structure-Activity Research Program) set up by the U.S. EPA to produce a solid base of uniformly measured effect levels of industrial chemicals. The large scale screening was performed according to a protocol, which is comparable to OECD 203 standards and the usual Quality Assurance measures were applied, which are comparable to GLP. Thus the study is considered valid and conclusive.

The test animals were during 96 exposed in a flow-through system to mean measured concentrations of <3.5 (control), 10.7, 61.1, 89.3, 133, and 199 mg/L. The LC50 was found to be 101 mg/L, while the NOEC was 61.1 mg/L and the LOEC 89.3 mg/L.

Description of key information

LC50 = 101 mg/L (94-108 mg/L, 95%C.I.), Pimephales promelas, 96h, Geiger 1985

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

101 mg/L

Additional information

The study by Broderius (1995) was disregarded, as the data reported on the pure substance were those from the literature (probably Geiger), and the newly generated data on mixtures with octanol or phenol was not considered relevant.

One relevant study from the literature was available, Geiger (1985), and is considered reliable and adequate for risk assessment, classification and labelling. The study covered the main elements required in the current OECD guideline 203, was of equivalent exposure duration (96h), and was well documented with quality control systems in place. As a result, and in accordance with Regulation (EC) No. 1907/2006, Annex XI, 1.1.2, further testing is not considered necessary for this endpoint.