Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Diss Factsheets

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.001 mg/L
Assessment factor:
10
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.007 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0 mg/L
Assessment factor:
100
Extrapolation method:
assessment factor

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
20.4 mg/L
Assessment factor:
100
Extrapolation method:
assessment factor

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
0.008 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.001 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:
0.001 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
1 mg/kg food
Assessment factor:
300

Additional information

In cases where no data is available for m-toluidine, read across with p-toluidine (CAS No. 106-49-0) is proposed to cover the respective endpoints. m-Toluidine and p-toluidine are isomers and have very similar chemical structures. Their main physico-chemical parameters (vapour pressure, water solubility, octanol/water partition coefficient, organic carbon partition coefficient and dissociation constant) are in the same range. The main ecotoxicological parameters like short-term toxicity on Daphnia and fish, toxicity on algae, and long-term toxicity on Daphnia are also in the same range. It is shown that Daphnia is the most sensitive aquatic organism for both isomers. Therefore a read across between these two substances to cover physico-chemical and ecotoxicological endpoints for m-toluidine seems to be justified. More details regarding the read across justification are depicted in the Read-Across Justification Document (RAAF) in chapter 13.

Conclusion on classification

m-Toluidine is legally classified as dangerous for the environment and so included in Annex I of Directive 67/548/EEC and in Regulation 1272/2008 (CLP), including its 2nd, 3th and 4th ATP.

According to the information summarised in this chapter, m-toluidine should be classified for the following reasons:

-Daphnia was the most sensitive among the organisms tested. The lowest acute and chronic toxicity values were 0.73 mg/L (Daphnia 48h LC50) and 0.01 mg/L (Daphnia 21 d NOEC), respectively.

-m-Toluidine is readily and inherently biodegradable.

-The bioaccumulation potential is assessed in a bioconcentration study on fish in a read-across approach from the structural analogue p-toluidine. BCF values of < 13 were determined, indicating a very low potential for bioaccumulation. This is in agreement with the experimental log Kow value of 1.40 of m-toluidine.

According to GHS (Regulation EC 1272/2008 including Commission Regulation EU-286/2011) m-toluidine should be classified as aquatic acute, category 1 with an M-factor of 1 and aquatic chronic, category 1 with an M-factor of 1.