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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
0.17 mg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
1.7 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
17 µg/L
Assessment factor:
10 000
Extrapolation method:
assessment factor
PNEC marine water (intermittent releases):
0.17 mg/L

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
81.6 µg/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:
63.5 µg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Adequate chronic toxicity data is not available for Optical Brightener 380, therefore the aquatic toxicity assessment and classification are based mainly on the short-term toxicity data available on Similar Substance 01. The usage of information on a structural analogous can be considered as suitable and appropriated; details on the approach followed are included in the document attached to the IUCLID section 13.

Optical Brightener 380 is not rapidly degradable. It has a log Kow lower than 4, indicating a low potential for bioaccumulation; in addition, on the basis of the molecular mass greater than 700, it is expected to be not readily taken up by fish, because of possible steric hindrance at passage of gill membranes or cell membranes of respiratory organs.

The substance was tested for toxicity potential on fish, aquatic invertebrates and algae. No acute toxicity (i.e. L(E)C50) was recorded in none of the experiments conducted, up to the higher concentration reached in the tests (i.e. 1000, 1000 and 170 mg/l, respectively).

Thus, the outcomes from the short-term tests performed on the three trophic levels suggest that is not harmful/toxic for aquatic life.

The test substance resulted to be no harmful-toxic for activated sludge and not negatively impacting the microorganism activity; thus, it is deemed to be not able to affect the sewage treatment plants systems function.

Direct releases to air and/or sediment and/or soil are considered to be not relevant, on the basis of the substance usages describe into the IUCLID section 3.3; in addition, the physicochemical properties support the expectation of low relevance of the mentioned compartments.

The primary source of possible substance environmental release is represented by industrial waste waters.

Conclusion on classification

Adequate chronic toxicity data is not available, therefore the aquatic toxicity assessment and classification are based mainly on the short-term toxicity data.

Optical Brightener 380 is a very water soluble substance, not rapidly degradable. In addition, it is characterized by a negative log Kow, indicating a low potential for bioaccumulation.

 

No L(E)C50 value was recorded at concentration equal/lower than 1 mg/l, thus the classification criteria for acute (short-term) aquatic hazard (category 1) of the CLP Regulation (EC) No 1272/2008 are not met.

In addition, no acute toxicity (i.e. L(E)C50) was recorded in none of the experiments conducted, up to the concentration of 100 mg/l; thus the classification criteria for long-term aquatic hazard (categories 2/3/4) of the CLP Regulation (EC) No 1272/2008 are not met.

 

In conclusion, the outcomes of the tests performed on the three trophic levels suggest that Optical Brightener 380 is not harmful/toxic for aquatic life.