Reaction mass of 2,6-Bis[(dimethylamino)methyl]-4-(1-{3-[(dimethylamino)methyl]-4-hydroxyphenyl}-1-methylethyl)phenol and 4-(1-{3,5-Bis[(dimethylamino)methyl]-4-hydroxyphenyl}-1-methylethyl)-2,6-bis[(dimethylamino)methyl]phenol

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

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Remarks:

DOC

Details on sampling:

Sampling schedule:
Control: at 96 hours
Test concentration: at 0, 24, 48, 72 and 96 hours

Vehicle:

no

Remarks:

auxiliaries were an ultrasonic batch and a magnetic stirrer

Details on test solutions:

- the test item was pulverized with a mortar and pestle
- 500.9 mg of the test item were added to 5 litres of dilution water, treated for 1 h in an ultrasonic bath and stirred for 24 h on a magnetic stirrer
- undissolved particles of the test item were removed by filtration using a folded filter (pore size of 7 - 12 µm= and an aseptic filter Sartobran sterile capsules (pore size of 0.45 µm + 0.2 µm)
- pH was measured to be 8.0

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

Name: Zebra fish (Danio rerio)
Source: Interaquaristik.de Shop (Germany)
Date supplied: 2017-09-28
Acclimatisation: Stock held since 2017-09-28 and acclimatised to the test conditions since then.
Temperature: 20 - 24 °C
Dissolved oxygen: > 5 mg/L
Feeding: Commercial fish food, daily. Feeding discontinued 24 h prior to test start.
Mortalities during acclimatisation period: < 5 %
Medication: none
Mean standard length (n = 14): 3.86 cm (S.D. = 0.19 cm)

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Hardness:

13.4 °dH (= 239 mg/L CaCO3)

Test temperature:

21.9 to 22.5 °C

pH:

7.6 - 8.0

Dissolved oxygen:

8.2 - 8.7 mg/L

Nominal and measured concentrations:

nominal: 100 mg/L
measured: 39.5 - 72.34 mg/L

Details on test conditions:

Test vessels: glass aquaria holding 5 L of test media covered by glass plates
Experimental design: 1 test concentration plus 1 control, 7 fish per test concentration, no feeding during the exposure period, static system
Method of initiation: fish were placed in prepared media
Loading: 0.84 g body weight (wet weight) per litre
Photoperiod: 16 h light: 8 h dark
Temperature: 21.9 to 22.5 °C
Aeration: gentle aeration via narrow glass tubes
Test item concentration/s: 100 mg/L (nominal)
Method of administration: direct weighing
Medium renewal: none
Duration of exposure: 96 hours
Criteria of effects: absence of response to physical stimulation; in addition to observations on mortality at 2, 24, 48, 72 and 96 hours, type and incidence of sub-lethal effects compared with control fish were observed.

Reference substance (positive control):

no

Duration:

96 h

Dose descriptor:

LL50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

The results are expressed in terms of Lethal Loadings (LL).
The substance has not a definite or unique structure and consists of several components. A Water Accommodated Fraction (WAF) was used to test effects at a limit lethal loading and no specific analysis was performed. With the sponsor’s agreement, the content of the test item during the exposure period was verified by DOC determination.

Validity criteria fulfilled:

yes

Remarks:

mortality in the controls did not exceed 10 % by the end of the test; dissolved oxygen concentration remained above 60 % of the air-saturation value throughout the exposure period; pH did not vary by more than 1 unit

Conclusions:

No toxic effects of HPP 12879-1 against fish (Danio rerio) were observed at a limit lethal loading of 100 mg/L after 96 h of exposure.

Executive summary:

A study was performed to assess the acute toxicity of HPP 12879-1 to Danio rerio under static conditions.

The study was conducted in accordance with Council Regulation (EC) No 440/2008, Method C.1 'Acute toxicity for Fish' (2008) which is in most parts equivalent to the OECD Guideline for Testing of Chemicals No. 203 'Fish, Acute Toxicity Test' (1992).

A range finding test preceded the main test. It provided information about the range of loadings which were used in the main test. The following nominal loadings of the test item were tested in the range-finding test: 10 and 100 mg/L.

Because of the anticipated low toxicity of the test item, a group of seven fish of the recommended size was exposed to a limit test concentration of nominally 100 mg/L of HPP 12879-1 dissolved in dilution water. Auxiliaries used to prepare the test media were an ultrasonic bath, a magnetic stirrer, a folded filter and an aseptic filter. During the test a temperature range of 20 - 24 °C was maintained in the test vessels, with a maximum temperature fluctuation of +/- 0.6 °C in the test. The temperature, the pH and the oxygen values were measured at the beginning of the test and every 24 hours thereafter.

Observations were made on the numbers of dead fish and the incidence of sub-lethal effects after 2, 24, 48, 72 and 96 hours of exposure. An 96h-LL50 of > 100 mg/L was determined. Thus, no toxic effects against fish (Danio rerio) were observed at a limit lethal loading of 100 mg/L.

The results are expressed in terms of Lethal Loadings (LL).

The substance has not a definite or unique structure and consists of several components. A Water Accommodated Fraction (WAF) was used to test effects at a limit lethal loading and no specific analysis was performed. With the sponsor’s agreement, the content of the test item during the exposure period was verified by DOC determination.

Description of key information

No toxic effects of HPP 12879-1 against fish (Danio rerio) were observed at a limit lethal loading of 100 mg/L.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

100 mg/L

Additional information

Should read > 100 mg/L.

The results are expressed in terms of Lethal Loadings (LL).

The substance has not a definite or unique structure and consists of several components. A Water Accommodated Fraction (WAF) was used to test effects at a limit lethal loading and no specific analysis was performed. With the sponsor’s agreement, the content of the test item during the exposure period was verified by DOC determination.