Didecyldimethylammonium chloride

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

19 Mar, 1990 - 27 Apr, 1990

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

No analytical dose verification

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

no

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Test type:

semi-static

Limit test:

no

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

ca. 0.97 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.:

ca. 0.49 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Sublethal observations / clinical signs:

96 hour-LC50 = 0.97 mg/l, with 95% confidence limits of 0.8-1.2 mg/L. The highest concentration causing no mortality (no observed effect concentration, NOEC) after 96 hours amounted to 0.56 mg/L. whereas 100% mortality was produced within 2 hours at 1.8 mg/L.
There were no effects observed on the behaviour of the fish during the exposure period, except for the fish at 1.0 mg/L
which showed reduced activity after 6 hours exposure.

Validity criteria fulfilled:

yes

Conclusions:

All validity criteria can be considered as fulfilled. The 96 h LC50 of the test substance in fish was 0.49 mg/L.

Executive summary:

Short term toxicity to fish was evaluated according to OECD Guideline 203 and EU Method C.1 under GLP conditions. Seven fish per concentration were exposed to 0.18, 0.32, 0.56, 1.0 or 1.8 mg/L of acommercial product containing 50% DDAC for 96 h. The test was conducted under semi-static conditions, with the test solution being renewed after 48 h. No analytical dose verification was performed and all values mentioned are nominal. The highest concentration causing no mortality (NOEC) after 96 h was 0.56 mg/L whereas 100% mortality occurred within 2 h at 1.8 mg/L. There were no effects on behavior during the exposure period, except for the fish at 1.0 mg/L which showed reduced activity after 6 h. The 96 h LC50 of the test substance was 0.49 mg a.i./L. All validity criteria can be considered as fulfilled.

Reference 2

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1990

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

No analytical dose verification

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

no

GLP compliance:

no

Analytical monitoring:

no

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Test temperature:

22°C

pH:

6.8 - 7.1

Dissolved oxygen:

7.93 - 8.05

Nominal and measured concentrations:

0, 0.25, 0.50, 1.00, 2.50 and 5.00 mg/L (nominal)

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

ca. 0.7 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Key result

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

ca. 0.5 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Key result

Duration:

96 h

Dose descriptor:

LC100

Effect conc.:

ca. 1 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Validity criteria fulfilled:

yes

Conclusions:

The 96h LC50 of the test substance for Brachydanio rerio was 0.7 mg/L. The 96h NOEC was 0.5 mg/L and the 96h LC100 was 1.0 mg/L.

Executive summary:

A study was conducted to determine the acute toxicity of DDAC to Brachydanio rerio according to OECD guideline 203. Fish were exposed to a commercial product (purity not stated) under static conditions for 96 hours. Mortality and lethargy were observed. The 96h LC50 of the test substance was 0.7 mg/L. The 96h NOEC was 0.5 mg/L and the 96h LC100 was 1.0 mg/L.

Description of key information

-         Key value from Registrant: 96 h LC50 = 0.49 mg a.i./L

-         Key value from DDAC biocides assessment report for Product Type 8 (June 2015): 96 h LC50 = 0.19 mg a.i./L

In the present report, the 96 h LC50 of 0.19 mg a.i./L was selected as key value, in line with the methodology followed in the DDAC biocides assessment report for Product Type 8.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

0.19 mg/L

Additional information

Short term toxicity to Zebra fish (Danio rerio) was evaluated according to OECD Guideline 203 and EU Method C.1, in compliance with GLP. Seven fish per concentration were exposed to 0.18, 0.32, 0.56, 1.0 or 1.8 mg/L of a commercial product containing 50% test substance for 96 h. The test was conducted under semi-static conditions, with the test solution being renewed after 48 h. No analytical dose verification was performed and all values mentioned are nominal. The highest concentration causing no mortality (NOEC) after 96 h was 0.56 mg/L whereas 100% mortality occurred within 2 h at 1.8 mg/L. There were no effects on behaviour during the exposure period, except for the fish at 1.0 mg/L which showed reduced activity after 6 h. The 96 h LC50 of the test substance was 0.49 mg a.i./L. All validity criteria can be considered as fulfilled (Akzo Nobel, 1990).  

 

Another study was conducted to determine the acute toxicity of the test substance to Zebra fish (Danio rerio) according to OECD Guideline 203. Fish were exposed to a commercial product (purity not stated) containing the test substance under static conditions for 96 h. Mortality and lethargy were observed. The 96 h LC50 was 0.7 mg/L. The 96 h NOEC was 0.5 mg/L and the 96 h LC100 was 1.0 mg/L (Akzo Nobel, 1990). 

The DDAC biocides assessment report for Product Type 8 conducted under Directive 98/8/EC (evaluating Competent Authority: Italy, June 2015, attached in Section 13 of the IUCLID dataset), reported an additional study on DDAC, apart from the above EQC studies. This study resulted in a 96 h LC50 = 0.19 mg a.i./L. The RMS considered the lower value from this study as the endpoint for the product authorisation.