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Short-term toxicity to aquatic invertebrates

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Reference
Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
(Q)SAR
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Remarks:
"These data are regarded as reliable. Fugacity data suggests low losses would be expected by evaporation, however as no measurements made, only rated reliable with restrictions" source UNEP publication.
Justification for type of information:
As a UVCB and natural complex substance, it is considered a constituents approach. This mother tincture contains about 65% (v/v) of ethanol.
Qualifier:
according to guideline
Guideline:
other: Method was that recommended by the American Society of Testing and Materials (1980) Standard practice for conducting acute toxicity tests with fishes, macro invertebrates and amphibians. ASTM Standard E729-80. Philadelphia, Pennsylvania.
Version / remarks:
1980
GLP compliance:
not specified
Specific details on test material used for the study:
Ethanol absolute (USP)
Analytical monitoring:
not specified
Vehicle:
not specified
Test organisms (species):
Ceriodaphnia sp.
Details on test organisms:
Organisms were mass cultured an acclimated to temperature for at least 10 weeks and maintained in filtered, autoclaved Lake Huron water.
Neonates hatched by isolated gravid females gathered by sieving. Age: Neonates. Control group: Dilution water controls. Test conditions: Ethanol not discussed.
Exposure vessel: Covered vials, not aerated, triplicates for each concentration.
Lighting: 646 lux +/- 85; 16 hr light, 8 hr dark.
Test type:
static
Water media type:
other: autoclaved Lake Huron water.
Total exposure duration:
48 h
Hardness:
90 mg/ L as CaCO3
Test temperature:
24°C
pH:
8.2 to 8.4
Dissolved oxygen:
8.4 to 10.3 mg/L
Conductivity:
Alkalinity 70 mg CaCO3, pH 8.8, TOC 5580 mug/l; TDS 140,000 mug/l; Ca/Mg 2.8. Na/K 4.3.
Key result
Duration:
48 h
Dose descriptor:
LC50
Effect conc.:
> 6 325 - <= 6 772 mg/L
Remarks on result:
other: 20°C
Key result
Duration:
48 h
Dose descriptor:
LC50
Effect conc.:
> 3 715 - <= 6 076 mg/L
Remarks on result:
other: 24°C

Table 11 Toxicity to invertebrates (UNEP Publication)

 Species  Test and time period  Values (mg/L)
 

Ceriodaphnia

 

LC 50 (48hr)

5012 
 

Daphnia magna

 

LC 50 (48hr)

 12340

 

Artemia salina

 

LC 50 (24hr)

 1833
 

Paramecium caudatum

 

LC 50 (4hr)

5980 
 

Palaemonetes kadiakensis

 

EC 50 (18hr)

1000
 

Daphnia pulex

 

EC 50 (18hr)

2000 
 

Hyallela azteca

 

EC 50 (18hr)

1000 
 

Artemia salina

 

EC 50 (24hr)

23874 
Validity criteria fulfilled:
yes
Conclusions:
48-hour studies with the pelagic invertebrates Daphnia magna and Cerodaphnia sp. were conducted using method ASTM Standard E729-80 and gave reliable LC50 values of 12,340 mg/l and 5012 mg/l respectively (Takahashi, 1987).
Hence, ethanol is practically non toxic to daphnia.

Description of key information

On a constituent approach, the acute toxicity of Ledum palustre mother tincture to aquatic invertebrates can be estimated using aquatic toxicity data from major constituents :

- ethanol : 65 % (+/- 5%)

- water : 35% (+/- 5%)

Ledum palustre MT aquatic invertebrate toxicity is extrapolated from Ethanol aquatic invertebrate toxicity data (worst case) :

 name of the component  % in the UVCB LC50 (48h) Ceriodaphnia sp. (mg/l)   LC50 (48h) Daphnia magna (mg/l)  LC50 (24h) Daphnia magna (mg/l)    source
 ethanol  65  5012  12340  10700    UNEP publication
 water  35  no acute toxicity for daphnia  no acute toxicity fo daphnia  no acute toxicity for daphnia    N/A
 Ledum palustre MT  100%  > 5012 > 12340  > 10700    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 invertebrates

Fresh water invertebrates
Effect concentration:
5 012 mg/L

Additional information

With a LC50 (48h) for daphnia between 7000mg/l and 18000 mg/l, Ledum palustre mother tincture is practically not harmful to daphnia and does not required any hazard statement regarding ecotoxicity (H400, H410, H411, H412, H413).