Ledum palustre, ext.

Short-term toxicity to aquatic invertebrates

Link to relevant study record(s)

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).