Betaines, C12-16 (even numbered) -alkyldimethyl

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:

March - April, 2019

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Version / remarks:

July 17, 1992

Deviations:

yes

Remarks:

Preliminary test only

Principles of method if other than guideline:

A preliminary concentration range-finding test was conducted to determine the approximate toxicity of the test item so that appropriate test concentrations could be selected for use in the definitive test. Four fish were exposed to each concentration of the test item plus a control, for 96 hours under semi-static conditions.
It was not possible to perform the main study when it became clear that the substance was used only in personal care products.

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

no

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION

- Formulation: A stock solution with a concentration of 100.0 mg/L (nominal) was prepared with direct addition of the test item, mixed into the test medium (aquarium water). The test solutions were prepared by appropriate diluting of this stock solution just before introduction of the fish

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: Zebra fish
- Source: Szent István University, Department of Aquaculture, 2100 Gödöllő, Páter Károly u. 1., Hungary


ACCLIMATION
- Acclimation period: > 12 days
- Health during acclimation (any mortality observed): Fish were observed during the acclimatisation and test periods; the fish were healthy. There was no mortality of the population for seven days before the test.

FEEDING DURING TEST
The fish were not fed during the test.

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Nominal and measured concentrations:

0.1, 1, 10 or 100 mg/L (nominal)

Details on test conditions:

Four fish used per dose level.
The frequency of the water renewal periods was 24 hours.

Reference substance (positive control):

no

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 0.1 - < 1 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

Localisation at the bottom of the aquarium or close to the surface of the water, swimming problems (decreased activity) and fast motility of operculum were observed at 1.0 mg/L (nominal) during the first 6 hours.

Sublethal observations / clinical signs:

Results of the preliminary range-finding test

Nominal Concentration [mg/L]	control	0.1	1	10	100
Number of treated animals	4	4	4	4	4
Number of dead animals	0	0	4	4	4

Validity criteria fulfilled:

not applicable

Conclusions:

Based on the preliminary range-finding study, the 96-h LC50 for Danio rerio is between 0.1 and 1 mg/L.

Executive summary:

A study was performed according to OECD TG 203 using Zebra fish (Danio rerio). A preliminary concentration range-finding test was conducted to determine the approximate toxicity of the test item so that appropriate test concentrations could be selected for use in the definitive test. Four fish were exposed to each concentration of the test item plus a control, for 96 hours under semi-static conditions. The frequency of the water renewal periods was 24 hours. No fish died at 0.1 mg/L, whereas all fish at 1 mg/L and higher doses died. Based on these results, the LC50 is estimated to be in the range of 0.1 to 1 mg/L.

It was not possible to perform the main study when it became clear that the substance was used only in personal care products.

Description of key information

96 -h LC50 (Danio rerio) is estimated to be in the range of 0.1 to 1 mg/L

Additional information

A study was performed according to OECD TG 203 using Zebra fish (Danio rerio). A preliminary concentration range-finding test was conducted to determine the approximate toxicity of the test item so that appropriate test concentrations could be selected for use in the definitive test. Four fish were exposed to each concentration of the test item plus a control, for 96 hours under semi-static conditions. The frequency of the water renewal periods was 24 hours. No fish died at 0.1 mg/L, whereas all fish at 1 mg/L and higher doses died. Based on these results, the 96 -h LC50 is estimated to be in the range of 0.1 to 1 mg/L.