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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Remarks:
Classification based on calculation rules for mixtures of the CLP Regulation
Type of information:
calculation (if not (Q)SAR)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
accepted calculation method
Justification for type of information:
Calendula officinalis mother tincture is a UVCB and natural complex substance, and is assesed through constituents approach taking into account one the main constituent : ethanol present at 55%.
Qualifier:
according to guideline
Guideline:
other:
Version / remarks:
static type
Principles of method if other than guideline:
test on 1974. no data
GLP compliance:
not specified
Remarks:
"Only nominal concentration measurements are available, However, fugacity data suggests low losses would be expected by evaporation. In addition there are no water quality data available and no GLP data." source UNEP publication
Analytical monitoring:
no
Vehicle:
not specified
Test organisms (species):
Oncorhynchus mykiss (previous name: Salmo gairdneri)
Details on test organisms:
Fish, estuary
Test type:
static
Water media type:
freshwater
Total exposure duration:
96 h
Hardness:
40-50 mg/l CaCO3
Test temperature:
12 deg C +/- 1 degC.
Nominal and measured concentrations:
Method of calculating mean measured concentration: Only nominal concentrations used.
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
ca. 13 000 mg/L
Conc. based on:
not specified
Basis for effect:
no data
Validity criteria fulfilled:
yes
Conclusions:
With a LC50 (96h) for fish up to 10,000mg/l, ethanol is practically non toxic to fish.

Description of key information

On a constituent approach, the acute toxicity of Calendula officinalis mother tincture to fish can be estimated using aquatic toxicity data from major constituents :

- ethanol : ca 55 % (+/- 5%)

- water : ca. 45% (+/- 5%)

Calendula officinalis MT fish toxicity is extrapolated from Ethanol fish toxicity data :

 name of the component  % in the UVCB  LC50 (96h) Salmo gairdneri fish (mg/l)   LC50 (96h) Pimephales promelas fish (mg/l)  LC50 (96h) Alburnus alburnus (mg/l)    source
 ethanol  55  13000  13480  11000    UNEP publication
 water  45  no acute toxicity for fish  no acute toxicity fo fish  no acute toxicity for fish    
 Calendula officinalis MT  100%  > 13000  > 13480  > 11000   Prediction value (according to point 4.1.3.4.2 and 4.1.3.5 of regulation EC 1272/2008)

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Effect concentration:
11 000 mg/L

Additional information

Calendula officinalis mother tincture fish LC50 (96h) is between 11000 mg/l and 14000 mg/l

Calendula officinalis mother tincture is not harmful to fish and is not classified hazardous.