Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
no hazard identified

Marine water

Hazard assessment conclusion:
no hazard identified

STP

Hazard assessment conclusion:
no hazard identified

Sediment (freshwater)

Hazard assessment conclusion:
no hazard identified

Sediment (marine water)

Hazard assessment conclusion:
no hazard identified

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
no hazard identified

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Conclusion on classification

EU regulation No 1272/2008 (CLP; amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006):

CLP classification as "Acute (short-term) aquatic hazard", Acute Category 1 as 96 hr EC50 (for fish) is 0.25 mg/L (i.e. lower than 1 mg/L).

CLP classification as "Chronic (long-term) aquatic hazard", Chronic Category 1 (Note 1) as 96 hr LC50 (for fish) is 0.25 mg/L (i.e. lower than 1 mg/L) and the log Kow is 6.05 at 25°C (i.e. higher than 4). (M factor=1)

Remark: The classification is based upon a worst case scenario and not the general exposure scenario.

The LC50 (96h, fish) is derived at concentrations exceeding the water solubility of TODI.***

TODI reacts very fast with water (hydrolysis). The log Pow of the postulated product of hydrolysis of TODI (TODA, substance name: 4,4'-bi-o-toluidine; alternative name: 3,3'-Dimethyl-4,4'-diamino-biphenyl, CAS no. 119 -93 -7, EC no. 204 -358 -0) at 25 °C was estimated to be equal or lower than 3.

*** TODI as such is hardly soluble in water (See IUCLID section 4.6., water solubility), therefore Dimethylformamide was used as auxiliary solvent / dispersant in the acute toxicity test to fish, to aquatic invertebrate and to aquatic algae, respectively. Moreover, TODI showed to be highly unstable in aqueous media, with hydrolysis occurring virtually instantaneously on contact with water and the degradation product was found to be insoluble in organic and aqueous solvents. (See IUCLID sections 6.1.1, short-term toxicity to fish and 6.1.3, short-term toxicity to aquatic invertebrate). That means that (1.) the acute toxicity tests represent the worst case as the solubility in water was increased by an auxiliary solvent and (2.) a chronic exposure to the TODI, respectively to its degradation product is negligible due to the insolubility of both if no auxiliary solvent is used.

On the other hand, the insolubility in water or aqueous solvents and the missing ready biodegradability of TODI (not so relevant because of rapid hydrolysis) and its degradation product and the calculated log Kow of 6.05 for TODI may indicate and trigger H413 classification for precautionary reasons.

However, the estimated log Kow of the hydrolysis product TODA (log Kow= 2.34 - 3 .02), as well as the experimentally BCF of TODA (BCF < 83) does not indicate long-lasting effects in the aquatic compartment.