Registration Dossier
Registration Dossier
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EC number: 203-157-5 | CAS number: 103-90-2
Ecotoxicological Summary
Administrative data
Hazard for aquatic organisms
Freshwater
- Hazard assessment conclusion:
- PNEC aqua (freshwater)
- PNEC value:
- 0.134 mg/L
- Assessment factor:
- 1 000
- Extrapolation method:
- assessment factor
- PNEC freshwater (intermittent releases):
- 1.34 mg/L
Marine water
- Hazard assessment conclusion:
- PNEC aqua (marine water)
- PNEC value:
- 0.013 mg/L
- Assessment factor:
- 10 000
- Extrapolation method:
- assessment factor
STP
- Hazard assessment conclusion:
- PNEC STP
- PNEC value:
- 1.89 mg/L
- Assessment factor:
- 100
- Extrapolation method:
- assessment factor
Sediment (freshwater)
- Hazard assessment conclusion:
- PNEC sediment (freshwater)
- PNEC value:
- 209.812 mg/kg sediment dw
- Extrapolation method:
- equilibrium partitioning method
Sediment (marine water)
- Hazard assessment conclusion:
- PNEC sediment (marine water)
- PNEC value:
- 209.812 mg/kg sediment dw
- Extrapolation method:
- equilibrium partitioning method
Hazard for air
Air
- Hazard assessment conclusion:
- no hazard identified
Hazard for terrestrial organisms
Soil
- Hazard assessment conclusion:
- PNEC soil
- PNEC value:
- 73.586 mg/kg soil dw
- Extrapolation method:
- equilibrium partitioning method
Hazard for predators
Secondary poisoning
- Hazard assessment conclusion:
- no potential for bioaccumulation
Additional information
Classification is not triggered based on available data, according to REGULATION (EC) No 1272/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006.
Conclusion on classification
Classification of paracetamol for effects in the environment
Several major guideline – experimental and estimation values (Klimisch 2) are available for paracetamol, which indicates no substantial toxic effect in the three key trophic levels (fish, invertebrates and algae) when exposed to the substance, paracetamol at concentrations up to its limit of solubility in the respective test media. Among the values lower values which lead to the classification of the substance the value which have been considered for further calculation (algae) is EC50 = 134 mg/L.
In determining the classification appropriate to paracetamol, it is necessary to consider all available evidence concerning its persistence, potential to accumulate and predicted or observed environmental fate and behaviour that may present a long-term and/or delayed danger to the structure and/or functioning of aquatic ecosystems. These points are considered below.
Persistence
Reliable studies are available to demonstrate that paracetamol is non persistent in nature and so is considered to be biodegradable in the environment. In other words paracetamol may therefore be expected to degrade rapidly. Thus it can be inferred that paracetamol is non persistent in environment.
Paracetamol is non persistent and does not satisfy the criteria for classification as persistent (P).
Potential to accumulate
Predicted and measured log Kow values for paracetamol are less than 4. The potential for paracetamol to bioaccumulate in the tissues of organisms that inhabit aquatic or terrestrial matrices is negligible as the BCF factor for the substance is less than 1000.
Classification is not triggered based on available data, according to REGULATION (EC) No 1272/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006.
The calculated BCF of cinnamaldehyde is 3.2 dimensionless and below the threshold of 2000.
Paracetamol does not satisfy the criterion for classification as bioaccumulative (B).
The toxicity values of fish, invertebrates and algae are LC50 = 160 mg/L, EC50 = 136 mg/L are EC50 = 134 mg/L, respectively. All the values of the 3 trophic levels do not fall in any criteria for classification (CLP regulation) and so will not qualify for classification as per the CLP regulation in ant of the criteria.
Paracetamol does satisfy the environmental effects criterion for classification as toxic (T).
Paracetamol is therefore neither P & B (or vPvB) substance, nor will qualify as T.
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