Registration Dossier
Registration Dossier
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EC number: 202-810-1 | CAS number: 100-01-6
PBT assessment
Administrative data
PBT assessment: overall result
- PBT status:
- the substance is PBT / vPvB
- Justification:
Classification of 4 - nitroaniline for effects in the environment
Several major guideline – estimation values (Klimisch 2) are available for 4 - nitroaniline, indicates substantial toxic effect in all the 3 key trophic levels (fish, invertebrate and algae). Among the values lower values which lead to the classification of the substance the value which have been considered for further calculation (invertebrate) is LC50 = 24 mg/L.
In determining the classification appropriate to 4 - nitroaniline, 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 4 - nitroaniline is non persistent in nature and so is considered to have rapid biodegradation in the environment. In other words 4 - nitroaniline degradation may therefore be expected to be fast. Thus it can be inferred that 4 - nitroaniline is non persistent in character.
4 – Nitro aniline is non persistent and so do not satisfy the criteria for classification as persistent (P).
Potential to accumulate
Predicted and measured log Kow values for 4 - nitroaniline is less than 4 (Log Kow = 1.2). The potential for 4 - nitroaniline 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.
The calculated BCF of 4 - nitroaniline is 3.8 dimensionless and below the threshold of 2000.
4 – Nitro aniline does not satisfy the criterion for classification as bioaccumulative (B).
The toxicity values of fish, invertebrates and algae are LC50 = 35 mg/L, LC50 = 24 mg/L are EC50 = 68 mg/L, respectively. The toxicity values of all the trophic levels fall in the criteria for classification (CLP regulation) and so will qualify for classification as per the CLP regulation for level 3 and the decision is based on the toxicity level of fish.
So, 4 - nitroaniline satisfies the environmental effects criterion for classification as toxic (T).
Thus it can be inferred that 4 - nitroaniline not P & B (including vPvB) substance, but will qualify as T.
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