Quaternary ammonium compounds, N,N,N'-tris(hydroxyethyl)-N,N'-dimethyl-N'-C16-18 (even numbered) and C18 unsatd., alkyltrimethylenedi-, bis(Me sulfates) (salts)

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to fish

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

1990

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Analytical monitoring of the test substance is not done

Justification for type of information:

Refer to section 13 for details on the read-across justification. The study with the read across substance is considered sufficient to fulfil the information requirements as further explained in the provided endpoint summary.

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

yes

Remarks:

Analytical monitoring is not done

GLP compliance:

yes

Analytical monitoring:

no

Vehicle:

yes

Remarks:

deionized water

Details on test solutions:

The test solutions in both the preliminary and the defintive test were prepared from stock solutions of the test substance in deionized water.
The test substance dissolved well and a homogeneous solution was obtained. The test concentrations were prepared by addition of the respective amounts of stock solution to the DSW. No chemical analyses of the test substance dissolved in the test media were performed. Therefore, all concentrations mentioned in this report are nominal concentrations.

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

- Test organism: Brachydanio rerio (zebra fish)
- Bodyweight and lenght: The fish were approximately 3 cm in size and the medium wetweight per fish was approximately 0.3 g.
- Source: The fish were obtained from a well-known local aquarim retailer and entered in the in-house purchase register as Batch 15-3-90.
- Acclimitisation period: Before being used in the definitive test, the fish were kept for at least 12 d in the Akzo Research Laboratories, dept. CBL, in conformity with Standard Operation Procedure T 42, to determine the acceptability of the batch.
- Water and feed: The water they were kept in was Dutch Standard Water (DSW). The fish were fed one to three times each day (6 days a week), the last feeding taking place about 24 hours before the test was started.

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Hardness:

13°dH

Test temperature:

21 to 23°C

pH:

7.3-8.1 pH

Dissolved oxygen:

Did not fall below 60% saturation

Nominal and measured concentrations:

Nominal concentrations: 0.18, 0.32, 0.56, 1 and 1.8 mg/L

Details on test conditions:

The deionized water contained not more than 10 pg of copper per litre, had a conductivity of less than 5 pS/cm and the TOC-content was not more than 2.0 mg/L. The biomass load of the test vessels was approximately 0.7 g of biomass/L. During the test the test medium was not aerated and the animals were not fed.

The test was carried out in a temperature controlled incubator. During the test the temperature was continuously registered in the liquid of the control vessel by means of a temperature sensor. The temperature was kept between 21°C and 25°C. The light regime was 12 hours of ambient light per day, provided by fluorescent tubes. Measurements of pH and the oxygen concentrations were carried out daily.

Reference substance (positive control):

yes

Remarks:

Potassium Dichromate

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

0.7 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

0.35 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Results with reference substance (positive control):

The concentrations tested: 100, 210 and 460 mg/L.
The pH of the stock solution was adjusted to approximately 8 with NaOH.
The quality of the batch fish used in the test was further checked by means of a test with a reference substance (potassium dichromate).
The results obtained are in accordance with the test results of an EEC norm study that refers to a concentration of 205.5 mg/L as LC50 48h (mean value).

Reported statistics and error estimates:

In deviation to the study plan, only the LC50 of the reference substance was determined with an LC50 programme Griffioen (RIZA) based on a model of Kooyman (1981).

The LC50 of test substance was calculated with a program using the binomial method (Stephan, 1977). This change of the method of calculation was necessary because there were less than two partial mortalities in the test.

Sublethal observations / clinical signs:

Mortality in definative Test

Nominal concentration (mg/L)	24 h	48 h	72 h	96 h
Control	7	7	7	7
0.18	7	7	7	7
0.32	7	7	7	7
0.56	7	7	7	7
1.0 After 23 h	0
1.8 After 7 h	0

Validity criteria fulfilled:

yes

Remarks:

With restrictions

Conclusions:

Under the study conditions, the 96 h LC50 of the test substance in Danio rerio was determined to be 0.7 mg/L (i.e equivalent to 0.35 mg a.i./L) (nominal).

Executive summary:

A study was conducted to determine the short-term toxicity of the read-across substance, N,N,N',N',N''-Pentamethyl-N-C16-18 (even numbered) and C18 unsat.-alkyl-1,3-propanediammonium chloride, to Danio rerio (zebra fish) according to OECD 203 Guideline, in compliance with GLP. Danio rerio (7/group) were exposed to the test substance at nominal concentrations of 0.18, 0.32, 0.56, 1 and 1.8 mg/L for 96 h. No analytical monitoring was conducted to determine the test substance concentrations in test media, however test substance is considered as stable in testing media. No mortality was observed after 96 h till 0.56 mg/L, whereas 100% mortality was produced within 23 h at 1.0 mg/L and within 7 h at 1.8 mg/L. No other effects, such as deviations in the behaviour or the appearance of the fish, were observed, except at the highest concentration (1.8 mg a.i./L) shortly before their death (floating upside down). The 96 h LC50 was determined to be 0.7 mg/L (0.35 mg/L a.i./L). Under the study conditions, the 96 h LC50 of the test substance in Danio rerio was determined to be 0.7 mg/L (equivalent to 0.35 mg a.i./L) (nominal) (Akzo Nobel, 1990).

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Dose descriptor:

LC50

Remarks:

96 h

Effect concentration:

0.35 mg/L

Additional information

A study was conducted to determine the short-term toxicity of the read-across substance, N,N,N',N',N''-Pentamethyl-N-C16-18 (even numbered) C18 unsat.-alkyl-1,3-propanediammonium chloride, to Danio rerio (zebra fish) according to OECD 203 Guideline, in compliance with GLP. Danio rerio (7/group) were exposed to the test substance at nominal concentrations of 0.18, 0.32, 0.56, 1 and 1.8 mg/L for 96 h. No analytical monitoring was conducted to determine the test substance concentrations in test media, however test substance is considered as stable in testing media. No mortality was observed after 96 h till 0.56 mg/L, whereas 100% mortality was produced within 23 h at 1.0 mg/L and within 7 h at 1.8 mg/L. No other effects, such as deviations in the behaviour or the appearance of the fish, were observed, except at the highest concentration (1.8 mg a.i./L) shortly before their death (floating upside down). The 96 h LC50 was determined to be 0.7 mg/L (0.35 mg/L a.i./L). Under the study conditions, the 96 h LC50 of the test substance in Danio rerio was determined to be 0.7 mg/L (equivalent to 0.35 mg a.i./L) (nominal) (Akzo Nobel, 1990).