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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

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Toxicity on Fish

The 48h-LC50 for the test substance in fish ranges from 38 to 91 mg/L. In the 96-h early life stage study a NOEL value of 0.2 µmol/L was established for the test substance. However, this study was disregarded due to major methodology deficiencies, mainly related to exposure duration and general sensitivity of the test.

A 35-days early life stage according to the OECD guideline 210 was therefore carried in order to cover several life stages of the fish from newly fertilised egg, through hatch to early stages of growth. Under test conditions, no effects on hatching, body lenght and weight were detected during the study at the highest concentration applied. Post hatch mortality was instead observed and the NOEC value was found to be 0.03 mg/L, based on geometric mean.

Toxicity on Daphnia Magna

Two studies testing the test substance in D. magna gave different results for the 48h-EC50, 0.174 mg/L (von der Ohe et al., 2005) and 5.6 mg/L (Min. of the Environ. Japan, 2010). The 48h-EC50 for invertebrates exposed to aniline and other methylanilines ranged from 0.08 to 0.52 mg/L. Hence the 48h-EC50 value of 0.174 mg/L appears to be the most reliable for the test substance. For prolonged exposure an EC50 value of 0.59 mg/L and a NOEC of 0.29 mg/L were found (Min. of the Environ. Japan, 2010). Comparing these results with the acute EC50 of 0.174 mg/L and the 21-d EC50 of 0.021 mg/L for aniline, the actual value of the 21d-EC50 for the test substance is 0.09 mg/L and the NOEC in the range of 0.02 mg/L.  

Toxicity to algae

The 72h-EC50 value for algae ranged from 3.8 mg/L. The ultimate NOEC corresponds with 0.14 mg/L.

Comparing the three trophic levels, the early life stages of zebra-fish and the daphnids appear to be the most sensitive. The most reliable is the NOEC for the early life stages of fish and this is used for further risk assessment.


Justification for classification or non-classification

In the long-term studies available, Daphnia and Fish resulted to be the more sensitive species. NOEC value found for the two trophic levels are comparable (0.03 mg/L for fish, 0.02 mg/L for Daphnia M.).

According to the CLP Regulation n.1272/2002, Table 4.1.0 "Classification categories for substances hazardous to the aquatic environment" b) i), substances with NOEC values below 0.1 mg/L are allocated in Category 1.

Taken into account the experimental values found in the available studies a classification as Aquatic Chronic 1 is considered as adequate.

This class hazard, deriving from the experimental studies used in this dossier, is in line with the harmonized classification of N-methylaniline.