Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Ecotoxicological information

Short-term toxicity to fish

Currently viewing:

Administrative data

Link to relevant study record(s)

Reference
Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
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)
Deviations:
no
GLP compliance:
yes
Analytical monitoring:
no
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: stock solutions prepared (180 mg / 10 mL DMSO) and further diluted with DMSO. 150 μg DMSO solution mixed with 1.5 L dilution water
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+/- 0.2 cm
- Weight at study initiation: 0.09 +/- 0.02 g
- Feeding during test: no
Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Hardness:
ca. 210 mg CaCO3/L
Test temperature:
24-26 °C
pH:
7.5 - 8.2
Dissolved oxygen:
> 6.7 mg/L
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: 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
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
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
1 mg/L
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 1 - 1.8 mg/L
Duration:
96 h
Dose descriptor:
LC100
Effect conc.:
1.8 mg/L
Details on results:
- Mortality of control: No mortality was observed in the controls after 24, 48, 72 and 96 hours
Sublethal observations / clinical signs:

No confidence interval could be calculated because of the steep concentration-effect curve. 

Parameter            Nominal conc. (mg/l) 

24h LC50                     1.8

48h LC50                     1.3

72h LC50                     1.3

Validity criteria fulfilled:
yes
Conclusions:
The test results indicate that Chlorhexidine dihydrochloride is acutely toxic towards fish. The 96h-LC50 was determined to be 1-1.8 mg/L.

Description of key information

A GLP acute toxicity study with Danio rerio according to the OECD 203 guideline was performed. The test results indicate that Chlorhexidine dihydrochloride is acutely toxic towards fish. The 96h-LC50 was determined to be 1-1.8 mg/L.

Key value for chemical safety assessment

Additional information