Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.115 mg/L
Assessment factor:
100
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.115 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.011 mg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
7.9 mg/L
Assessment factor:
10
Extrapolation method:
assessment factor

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.009 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:
0.02 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Classification of 2,2,2-trichloroethane-1,1-diol (chloral hydrate) for effects in the environment

In determining the classification appropriate to chloral hydrate, 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

The Fugacity model III of EPI Suite indicates the half life of the 2,2,2-trichloroethane-1,1-diol as 37.5 days in water medium, which clearly indicate that the substance 2,2,2-trichloroethane-1,1-diol is not persistent in water medium as well as in soil (half life 75 days). Thus, the chemical is likely to qualify as Not Persistent

 

Potential to accumulate

The estimated log Kow values for 2,2,2-trichloroethane-1,1-diol (Chloral hydrate)

is less than 4 (Log Kow = 0.99). The potential for Chloral hydrate 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 2000.  The estimated BCF of chloral hydrate is highest 3.162 dimensionless and below the threshold of 2000. 

 

Thus, chloral hydrate does not satisfy the criterion for classification as bio-accumulative (B).

 

The toxicity values (most conservative value) of fish, invertebrates and algae are LC50 = 97 mg/L, EC50 = 99 mg/L and ErC50 = 96 mg/L, respectively. These values suggest that the chemical is not expected to exhibit Aquatic toxicity. This is in agreement with the Harmonized classification of Chloral hydrate that does not have Aquatic toxicity.

 

Also, as per the criteria of Annex XIII of the REACH regulation, the chemical chloral hydrate is not expected to qualify the criteria as Toxic. Thus, it is a not toxic chemical.

 

Thus, the chemical chloral hydrate is not a PBT chemical.

Conclusion on classification

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. This chemical has a harmonized classification which does not indicate any type of environmental classification.