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Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0 mg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
22 mg/L
Assessment factor:
1
Extrapolation method:
assessment factor

Hazard for air

Hazard for terrestrial organisms

Hazard for predators

Additional information

No long-term exposure studies to determine the effects of a substance on aquatic organisms were conducted. Data on short-term toxicity for organisms representing 4 different trophic levels/groups of organisms (microorganisms, algae, invertebrates and fish) are available.

There are two EC50 values for the same species and end-point available thus the geometric mean was calculated for further PNEC estimation. The analysis of test conditions was performed in order to find out why differences in response were present. The slight discrepancy in EC50 (∆ 0.067 mg/L) may result from the differences in test duration 24 h and 48 h as well as the purity of the test substance 89.39 % and 91.2 % in Acute toxicity test and Acute immobilisation test respectively.

For PNEC estimating an assessment factor method was applied.

The most sensitive trophic level are the invertebrates (Daphnia magna) EC50 (24 h) = 0.09 mg/l (Acute toxicity test) and EC50(48 h) = 157.2 µg/L (Acute immobilisation test). According to EU, 2001; WHO, 2002 the assessment factor (AF) of 1000 is to use in a case that only short term toxicity data are available on the three trophic levels.

The PNECwater = 0.1188 mg/L / 1000 = 0.0001188 mg/L ≈ 0.12 μg/L.

Data from an activated sludge respiration inhibition test are available. On the basis of 16 hour toxicity study results (equivalent to bacterial growth inhibition toxicity study) the derivation of PNEC for sewage treatment plant (STP) applying the assessment factor method was performed.

The PNECstp was set equal to a NOEC or EC10 (assessment factor 1) as the test with specific bacterial populations such as nitrifying bacteria (Pseudomonas putida) was performed.

The PNECstp = 22 mg/L /1 = 22 mg/L.

Conclusion on classification

According to Directive 67/548/EEC as well as GHS Regulation EC No 1272/2008 HC-2009-257 Tego-Amid was classified as acute (short-term) aquatic hazard Category 1with M-factor of 1.

Labelling as “Warning, H400: Very toxic to aquatic life, P273, P391, P501 “is required.

The classification of a substance in acute Category 1 is defined on the basis of acute aquatic toxicity data (EC50). The data were derived using the standardised test. All available toxicity values used to define the appropriate hazard category are under the 1 mg/l value. Though BCF is ranging from 15- 678 (calculated data) the substance was experimentally determined as “Readily biodegradable (81 % in 28 days)”