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Long-term toxicity to aquatic invertebrates

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Reference
Endpoint:
long-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study without GLP and analytics but acceptable for assessment.
Principles of method if other than guideline:
Semi-Static toxicity test
GLP compliance:
no
Analytical monitoring:
no
Test organisms (species):
Daphnia magna
Details on test organisms:
Age of test animals: < 24 h
Water media type:
freshwater
Hardness:
160 to 180 mg/L
Test temperature:
21 to 23 °C
pH:
8.0 to 8.5
Dissolved oxygen:
7 .5 to 8.0 mg/L
Duration:
21 d
Dose descriptor:
EC50
Effect conc.:
3 721 mg/L
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
1 500 mg/L
Basis for effect:
reproduction
Duration:
21 d
Dose descriptor:
LOEC
Effect conc.:
3 000 mg/L
Duration:
21 d
Dose descriptor:
other: GM-MATC
Effect conc.:
2 121 mg/L

NOECs/LOECs (mg/L) depending on measured endpoint after 21 days:

NOEC (reproduction): 1500 mg/L
LOEC (reproduction): 3000 mg/L
NOEC (mortality): 3000 mg/L
LOEC (mortality): 6000 mg/L
NOEC (growth): 3000 mg/L
LOEC (growth): 6000 mg/L

Validity criteria fulfilled:
yes
Executive summary:
A Short-Cut Chronic Toxicity Estimation (no guideline followed) was performed by Adams and Heidolph (1985) using Daphnia magna. The results are listed below. NOECs/LOECs (mg/L) depending on measured endpoint after 21 days:
NOEC (reproduction): 1500 mg/L
LOEC (reproduction): 3000 mg/L
NOEC (mortality): 3000 mg/L
LOEC (mortality): 6000 mg/L
NOEC (growth): 3000 mg/L
LOEC (growth): 6000 mg/L

Description of key information

NOEC (21 d) = 1500 mg/L for Daphnia magna (no guideline followed, semi-static, non-GLP).

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates
Effect concentration:
1 500 mg/L

Additional information

Chronic toxicity of DMF to Daphnia magna was investigated by Adams and Heidolph (1985). The scientists determined a GM-MATC = 2121 mg/L after 21d exposure (GM-MATC is the geometrical mean of the highest concentration producing no significant effects and the lowest concentration producing a statistically significant effect). According to the EU TGD a NOEC can be derived from this value by dividing it by square root. Therefore a NOEC of about 1500 mg/L is determined.

In 2008, a diploma thesis performed at BASF SE (Jarosz, 2008) studied the long-term effects of the test substance on Daphnia magna. The NOEC for reproduction was determined to be 100 mg/L. However, during the semi-static test a drop in oxygen saturation was observed beginning 14 days after start of the exposure. Though the oxygen content remained above the required 3 mg/L, it is indicative for problems in the test system which could not be further defined.

Additionally, QSAR calculations are conducted using an extensive set of structure – activity relationships (SARs) by the computer program ECOSAR from US-EPA. Thereby, a chronic value (ChV) of 93.6 mg/L is obtained for daphnids. The substance failed to fall in the applicability domain of the model.