Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Diss Factsheets

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.449 µg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.045 µg/L
Assessment factor:
10 000
Extrapolation method:
assessment factor

STP

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

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

Target substance is usually maintained in pH above 11 because it becomes unstable if pH drops below 9. In very low pH (<4) the substance will release chlorine gas. When substance is introduced to test conditions, it will become unstable making analytical quantification difficult.

 

Because of these properties of test substance, samples of test medium in the key studies were not collected during the exposure period for the analytical verification of the test solutions. Test substance could not be quantified in the test system due to the nature of the material being unstable under the test conditions and the fact that no suitable analytical technique with the required sensitivity could be determined. The results of key studies were based on nominal test concentrations

 

The key studies used in the PNEC derivation and C&L were conducted on the test substance complying with GLP and fulfilling OECD guidelines. Short-term toxicity to fish for fresh and salt water were based on read-across data from studies conducted on analogue substance sodium hypochlorite. These studies were not done according GLP or guidelines and did not have enough information on the test conditions or methodology and therefore they were not used for C&L purposes. However, they were used as Weight of Evidence approach to evaluate the acute toxicity effects and the hazard assessment.

Conclusion on classification

The following key information is used for the classification of the target substance:

Acute aquatic toxicity:

Toxicity to algae (Pseudokirchneriella subcapitata): 72 -h EC50 449 µg/l and NOEC 215 µg/l (OECD 201, GLP)

Toxicity to invertebrates (Daphnia magna): 48 -h EC50 0.94 mg/l (OECD 202, GLP)

Short-term toxicity to freshwater fish (Leiostomus xanthurus): 96-h LC50 0.09 mg/l (read-across, WoE, non-guideline study)

Short-term toxicity to marine water fish (Oncorhynchus kisutch): 96 -h LC50 0.03 mg/l (read-across, WoE, non-guideline study)

Respiratory inhibition of activated sludge: 3-h EC50 251.5 mg/l (OECD 209; GLP)

 

Conclusion:

The target substance is classified to hazard class: Aquatic Acute Toxic cat. 1 because the lowest toxicity value indicate the EC/LC50 value is (448 g/µl, 72 -h ErC50, Pseudokirchneriella subcapitata) below 1 mg/l. The M-factor is 1 based on lowest EC50 value being between 0.1 mg/L < and ≤ 1 mg/L.

 

Chronic aquatic toxicity:

Since no long-term aquatic toxicity results are available the toxicity is evaluated based on the short-term study results and the degradation and bioaccumulation properties.

 

Acute toxicity:

EC/LC50-value <1 mg/l (448 g/µl, 72 -h ErC50, Pseudokirchneriella subcapitata).

 

Degradation and bioaccumulation:

Bio-degradation is not an important fate process for the substance. The organic chemical groups in the reaction products will be biodegradable but the ultimate decomposition reactions are, based on the known reactions of free available chlorine, resulting inorganic reaction products not relevant for biodegradation. This substance degrades abiotically, and the half-life is dependent on the environmental conditions such as pH, temperature and organic matter. The ultimate degradation product is chloride. The estimated log Kow values for the reaction mass components are within a range of -4.18 to -1.89, and the estimated BCF factor around 3.16 L/kg (US EPA 2014). Therefore, the substance is not considered as persistent and/or bioaccumulative.

 

Conclusion:

Not to be classified for any of the aquatic chronic hazard classes. The analogue household bleaches (e.g. sodium hypochlorite) have also harmonised classification entry in CLP Annex VI for Aquatic Acute 1 H400. The available chlorine concentration of the target substance is appr. 7.7-8.6 % though no need to consider this substance as having chronic aquatic toxicity.

 

Classification and labelling:

CLP 1272/2008:

Aquatic Acute 1, H400

M-factor 1

DSD 67/548/EEC:

N; R50