Bis(hydroxyethyl)methyloleylammonium chloride

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:

1992

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Good quality study under GLP with certificate of analysis, however no chemical analyses. Therefore all concentrations in this report are nominal.

Justification for type of information:

Read-across data is presented from quaternary ammonium compounds, C12-18-alkylbis(hydroxyethyl)methyl, chlorides, CAS Number 71808-53-2, EC Number 276-038-9. This substance is considered to be close enough in structural integrity to the target substance, bis(2 -hydroxyethyl)oleylmethylammonium chloride, CAS Number 18448 -65 -2, EC Number 242 -332 -0, so as to justify valid read-across.

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Version / remarks:

no chemical analyses
tested fish were slightly bigger than reccomdended by OECD guideline, this however is expected not to have influenced the final results.

Deviations:

yes

Remarks:

no chemical analyses of test media

Principles of method if other than guideline:

no chemical analyses
tested fish were slightly bigger than reccomdended by OECD guideline, this however is expected not to have influenced the final results.

GLP compliance:

yes

Analytical monitoring:

no

Details on test solutions:

The test solutions in both the preliminary and the definitive 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. (DSW= Dutch Standard Water)

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

The test was performed with Brachydanio rerio (zebra fish). The fish were approximately 3.3 cm in size and the medium wet weight per fish was
approximately 0.15 g. The fish were obtained from a well-known local aquarium retailer on 1992.03.20 (Rasbora, Veenendaal. The Netherlands)
and entered in the in-house purchase register as Batch 20-3-1992. Since this time the fish were kept in the Akzo Research Laboratories, dept.
CRL. The water they were kept in was Dutch Standard Water (DSW, see paragraph 2.5). The fish were accepted according to SOP T 67.

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

Post exposure observation period:

No

Hardness:

11.7 ºdH

Test temperature:

22.0 - 23.4 ºC

pH:

7.8-8.2

Dissolved oxygen:

7.9- 8.9 mg O2/L

Salinity:

no data

Nominal and measured concentrations:

nominal concentrations: 0 - 1 - 1.8 - 3.2 - 5.6 - 10.0 mg/L.

Details on test conditions:

In the definitive test as test vessels were used 5-L glass aquaria containing 3 L of test medium. All aquaria were covered with a glass plate during the test. The diluting water used for the preparation of the test concentrations was a synthetic water, Dutch Standard Water, having a pH of
approximately 8.2 and a hardness of 11.7 ºdH. containing per litre of deionized water:
100 mg of NaHCO3
20 mg of KHCO3
200 mg of CaCI2 *2H20
180 mg of MgS04*7H20.

The deionized water contained not more than 10 µg of copper per litre, had a conductivity of less than 5 µS/cm and the TOC content was not more
than 2.0 mg/L. The biomass load of the test vessels was approximately 0.4 g of biomass/L. During the tests the test medium was aerated and the
animals were not fed.
The test was carried out in a temperature controlled incubator. During the test the temperature was registered in the liquid of the control vessel by
means of a temperature sensor. The light regime was 16 hours of ambient light per day, provided by fluorescent tubes.

The testmedium was renewed after 48 hours.

Reference substance (positive control):

no

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

1.84 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Remarks on result:

other: (1.38 - 2.45)

Key result

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

1.8 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.:

2.4 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: 98%CL (1.8-3.2 mg/L)

Key result

Duration:

96 h

Dose descriptor:

LC100

Effect conc.:

3.2 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Results with reference substance (positive control):

no reference substance tested

Reported statistics and error estimates:

96 h LC50= 2.4 mg/L with 98% Confidence Limits of 1.8-3.2 mg/L

Sublethal observations / clinical signs:

mg/L test substance	Number of surviving animals
	0 h	24h	48h	72h	96 h
Control	7	7	7	7	7
1.0	7	7	7	7	7
1.8	7	7	7	7	7
3.2	7	0	0	0	0
5.6	7	0	0	0	0
10	7	0	0	0	0

Validity criteria fulfilled:

yes

Conclusions:

Good quality study, however no chemical analyses therefore all concentrations nominal.

The LC50 (96 h) was calculated to be 2.40 mg/L with 98% confidence limits of 1.8 and 3.2 mg/L

Executive summary:

The short-term toxicity to fish of the test substance, Quaternary ammonium compounds, coco alkylbis(hydroxyethyl)methyl chlorides, CAS Number 70750 -47 -9, EC Number 274-846-6, [Quaternary ammonium compounds, C12-18-alkylbis(hydroxyethyl)methyl, chlorides, CAS Number 71808 -53 -2, EC Number 276 -038 -9], was investigated in a study conducted according to OECD Guideline 203 (Fish, Acute Toxicity Test).

The study was assigned a reliability score of 2 in accordance with the criteria for assessing data quality set forth by Klimisch et al. (1997).

This substance is considered to be close enough in structural integrity to the target substance, bis(2 -hydroxyethyl)oleylmethylammonium chloride, CAS Number 18448 -65 -2, EC Number 242 -332 -0, so as to justify valid read-across.

The LC50 (96 h) was calculated to be 2.40 mg/L with 98% confidence limits of 1.8 and 3.2 mg/L. The highest concentration causing no mortality (no observed effect concentration, NOEC) after 96 hours amounted to 1.8 mg/L, whereas 100% mortality was produced within 20 hours at 3.2 mg/L.

Description of key information

The short-term toxicity to fish of the test substance, Quaternary ammonium compounds, coco alkylbis(hydroxyethyl)methyl chlorides, CAS Number 70750 -47 -9, EC Number 274-846-6, [Quaternary ammonium compounds, C12-18-alkylbis(hydroxyethyl)methyl, chlorides, CAS Number 71808 -53 -2, EC Number 276 -038 -9], was investigated in a study conducted according to OECD Guideline 203 (Fish, Acute Toxicity Test).

This substance is considered to be close enough in structural integrity to the target substance, bis(2 -hydroxyethyl)oleylmethylammonium chloride, CAS Number 18448 -65 -2, EC Number 242 -332 -0, so as to justify valid read-across.

The study was assigned a reliability score of 2 in accordance with the criteria for assessing data quality set forth by Klimisch et al. (1997).

The LC50 (96 h) was calculated to be 2.40 mg/L with 98% confidence limits of 1.8 and 3.2 mg/L. The highest concentration causing no mortality (no observed effect concentration, NOEC) after 96 hours amounted to 1.8 mg/L, whereas 100% mortality was produced within 20 hours at 3.2 mg/L.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

2.4 mg/L