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Diss Factsheets
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EC number: 242-354-0 | CAS number: 18472-51-0
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Short-term toxicity to aquatic invertebrates
Administrative data
Link to relevant study record(s)
- Endpoint:
- short-term toxicity to aquatic invertebrates
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.2 (Acute Toxicity for Daphnia)
- Version / remarks:
- cited as 92/69/EEC (C.2.) (1992)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Infracor Chemistry Services
- Analytical monitoring:
- yes
- Details on sampling:
- At the time of test performance no analytical method with adequate sensitivity was available to analyse the test substance concentration in the concentration range used for testing was available. Due to these facts, only the test substance concentrations of the stock solution and of an additional stability control (= test substance concentration directly above the detection limit of 1 mg TOC/L) could be determined after 0 and 48 hours by TOC-analysis.
To avoid negative effects due to the inorganic C-compounds, test batches used for the analytical determinations were prepared without addition of NaHCO3. - Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: Daphnia magna Straus
- Strain: clone 5
- Source: Animals bred at the testing facility, originally derived from Dr. N. Caspers, Bayer AG, Leverkusen, Germany
- Age at study initiation: Neonates < 24 h old
- Method of breeding: For breeding the females were maintained in M4-medium in 1L beakers.
At two to three day intervals, the exuviae were syphoned off, the water was changed and the offspring removed from the breeding vessels.
At regular intervals of approximately 4 weeks, offspring was isolated from the vessels. They served as a basis for further breeding.
Females are separated from the offspring 24 hours before the start of the test. The litter produced overnight was used for the test.
The culture conditions ensure parthenogenetic reproduction.
- Feeding during test: no
ACCLIMATION
- Food type: Desmodesmus (formerly Scenedesmus) subspicatus, unicellular green algae
- Amount: Amount of food was such that the amount added was consumed by the animals
- Frequency: Daily - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 48 h
- Hardness:
- 14°dH = 250 mg CaCO3/L
- Test temperature:
- 20 +/- 1°C
- pH:
- 7.7 - 8.0
- Dissolved oxygen:
- 7.6 - 8.3 mg/L
- Nominal and measured concentrations:
- 0.0077, 0.013, 0.023, 0.040, 0.070, 0.12, 0.21 mg/L (concentration are based on the main product)
The measured recovery rate of the stock solution concentrations and stability control concentration after 48 hours did not deviate by more than 20 % from the freshly prepared solutions.
It can be concluded that the test substance concentration was stable during the whole exposure time. Therefore the nominal concentration of the stock solution was used to calculate the test substance concentrations in the test batches. - Details on test conditions:
- TEST SYSTEM
- Test vessel: 10 mL
- Type: open. Test substance is not volatile
- No. of organisms per vessel: 5 +/- 1
- No. of vessels per concentration (replicates): 4
- Biomass loading rate: Approx. 2 mL per test organisms
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Synthetic fresh water
- Ca/Mg ratio: 4 : 1
- Culture medium different from test medium: Yes, Elendt M4 medium as described in OECD Guideline 202
OTHER TEST CONDITIONS
- Adjustment of pH: No
- Photoperiod: Complete darkness
EFFECT PARAMETERS MEASURED : Immobility. Sampling at 24 and 48 hours - Reference substance (positive control):
- yes
- Remarks:
- Potassium dichromate
- Duration:
- 48 h
- Dose descriptor:
- EC0
- Effect conc.:
- 0.04 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- act. ingr.
- Basis for effect:
- mobility
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- 0.087 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- act. ingr.
- Basis for effect:
- mobility
- Remarks on result:
- other: 95% CI 0.07-0.12 mg/L
- Duration:
- 48 h
- Dose descriptor:
- EC100
- Effect conc.:
- 0.12 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- act. ingr.
- Basis for effect:
- mobility
- Results with reference substance (positive control):
- - Results with reference substance valid? yes
EC50 (24 h) > 1 mg/L (nominal concentrations)
EC100 (24 h) = 2 mg/L - Reported statistics and error estimates:
- EC50 -values were determined graphically
- Validity criteria fulfilled:
- yes
- Conclusions:
- The test results indicate that Chlorhexidine digluconate is acutely very toxic towards daphnia. The 48h-EC50 was determined to be 0.087 mg a.i./L.
Reference
|
EC50 |
95 % c.l. |
EC0 |
EC100 |
24h [mg/L] |
> 0.21 |
no data |
0.07 |
> 0.21 |
48h [mg/L] |
0.087 |
0.07-0.12 |
0.04 |
0.12 |
(concenrations are based on a.i.)
Although no substance specific analytical measurement was performed in the OECD202 study, the effect value retrieved based on nominal concentrations is plausible and acceptable. This is supported by the OECD211 study which contains substance specific analytical monitoring.
The OECD211 study was performed as a semi-static test design with 3 times per week test medium renewal. Adult mortality occurred only in the highest test concentration (0.3 mg test item/l corresponding to 61.8 µg a.i. CHDG/l) and started after 5 days of incubation (10% mortality). Analytical monitoring indicated that the substance concentration was sufficiently maintained.
Based on the analytical results and adult mortality results from the OECD211 study it can be concluded for an OECD202 study that the substance concentration should be maintained within a period of 48h and a 48h EC50 acute toxicity value should clearly be >61.8 µg a.i. CHDG/l. This indicate that the available OECD202 study is reliable and the available nominal effect value of 87 µg a.i. CHDG/l is plausible and acceptable as an acute effect value.
Description of key information
Acute toxicity towards invertebrates was tested with the water flea Daphnia magna, and the EC50 was established at 0.087 mg a.i./L.
Key value for chemical safety assessment
Fresh water invertebrates
Fresh water invertebrates
- Effect concentration:
- 0.087 mg/L
Additional information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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