D-gluconic acid, compound with N,N''-bis(4-chlorophenyl)-3,12-diimino-2,4,11,13-tetraazatetradecanediamidine (2:1)

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:

1988

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

no

GLP compliance:

yes

Analytical monitoring:

no

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Source: Commercial hatchery M.B. Ruysbroek B.V. (Noordvliet 159, Maassluis)
- Length at study initiation: 2.1+/- 0.1 cm
- Weight at study initiation: 0.09 +/- 0.014 g
- Feeding during test: no

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Hardness:

210 mg CaCO3/L

Test temperature:

24 - 26 °C

pH:

7.5 - 8.0

Dissolved oxygen:

> 5.9 mg O2/L

Nominal and measured concentrations:

1.8, 3.2, 5.6, 10.0, 18.0 mg/L + control (nominal concentrations)

Details on test conditions:

TEST SYSTEM
- Test vessel: 2000 mL
- Type: open. Test substance is not volatile
- Fill volume: 1500 mL
- Aeration: Slight aeration, not specified
- Renewal rate of test solution (frequency/flow rate): Semistatic, daily renewal
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 2
- Biomass loading rate: 150 mL/fish

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: DSWL, prepared from ground water from a locality near Linschoten (NL)

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: No data
- Light intensity: No data

EFFECT PARAMETERS MEASURED:
Mortality, condition of survivors, sampled every 24 h

Reference substance (positive control):

no

Remarks:

not required by Guideline

Duration:

96 h

Dose descriptor:

LC0

Effect conc.:

2 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

2.08 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC100

Effect conc.:

3.6 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Details on results:

- Mortality of control: No mortality was observed in the controls after 24, 48, 72 and 96 hours

Reported statistics and error estimates:

Calculations of LC50-values by probit analysis

Sublethal observations / clinical signs:

Effect data:

Concen­tration	Mortality
(n.c.)	Number				Percentage
[mg/L]	24h	48h	72h	96h	24h	48h	72h	96h
1.8	0	0	0	0	0	0	0	0
3.2	0	0	0	0	0	0	0	0
5.6	0	0	0	0	0	0	0	0
10.0	0	0	1	1	0	0	5	5
18.0	19	20	20	20	95	100	100	100

 Effect concentrations related to 20% solution:

	48 h [mg/L]	95 % c.l.	96 h [mg/L]	95 % c.l.
LC0	10.0 (n)	no data^1	10.0 (n)^2	no data^1
LC50	13,4 (n)	no data^1	10.4 (n)	no data^1
LC100	18.0 (n)	no data^1	18.0 (n)	no data^1

¹No confidence intervals for the LC values could be calculated because of the steep concentration-effect curve

²One fish was dead at 10.0 mg/L, but because 10 % mortality is allowed according to OECD Guideline 203 for the control fishes this concentration is recorded as the 96 h LC₀

Validity criteria fulfilled:

yes

Conclusions:

The test results indicate that Chlorhexidine digluconate is acutely toxic towards fish. The 96h-LC50 was determined to be 2.08 mg a.s./L.

Description of key information

In a study on the acute toxicity of Chlorhexidine digluconate towards fish the LC50 was determined to be 2.08 mg a.i./L, employing the zebrafish (Brachydanio rerio) as the test organism.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

2.08 mg/L