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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Ecotoxicological information

Toxicity to terrestrial plants

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Administrative data

Link to relevant study record(s)

Reference
Endpoint:
toxicity to terrestrial plants: long-term
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Justification for type of information:
The performance of a test for toxicity to terrestrial organisms is scientifically not justified. REACh Regulation (EC) No 1907/2006, Annex IX Section 9.4 Column 2 states:
"These studies do not need to be conducted if direct and indirect exposure of the soil compartment is unlikely."

Further, REACH Annex X, Sect. 9.4, Col. 2, states as follows:
“9.4: Long-term toxicity testing shall be proposed by the registrant if the results of the chemical safety assessment according to Annex I indicates the need to investigate further the effects of the substance and/or degradation products on terrestrial organisms. The choice of the appropriate test(s) depends on the outcome of the chemical safety assessment. These studies do not need to be conducted if direct and indirect exposure of the soil compartment is unlikely.”

Direct and indirect exposure of soil and soil macroorganisms is practically negligible, as:
1) HAT-ISO is manufactured and formulated in closed systems. Thus, direct and indirect exposure of soil and soil organisms during manufacturing and formulation is practically negligible.
2) Use of formulated HAT-ISO is also unlikely to result in direct and indirect exposure of soil and soil organisms. During use HAT-ISO is included in three-dimensional matrices of polymeric, resinous material and completely retained. Therefore, the direct and indirect release of HAT-ISO to soil and soil organisms is practically negligible. Therefore, direct and indirect exposure of HAT-ISO to soil is highly unlikely and performance of a test for toxicity to soil organisms is scientifically not justified. The Chemical Safety Assessment does not indicate the need to investigate toxicity to soil organisms further. For more details on exposure assessment see risk assessment report in section 13.

Description of key information

The performance of a test for toxicity to terrestrial organisms is scientifically not justified.

Key value for chemical safety assessment

Additional information

The performance of a test for toxicity to terrestrial organisms is scientifically not justified.

REACh Regulation (EC) No 1907/2006, Annex IX Section 9.4 Column 2 states:

"These studies do not need to be conducted if direct and indirect exposure of the soil compartment is unlikely."

Further, REACH Annex X, Sect. 9.4, Col. 2, states as follows:

“9.4: Long-term toxicity testing shall be proposed by the registrant if the results of the chemical safety assessment according to Annex I indicates the need to investigate further the effects of the substance and/or degradation products on terrestrial organisms. The choice of the appropriate test(s) depends on the outcome of the chemical safety assessment. These studies do not need to be conducted if direct and indirect exposure of the soil compartment is unlikely.”

Direct and indirect exposure of soil and soil macroorganisms is practically negligible, as:  

1) HAT-ISO is manufactured and formulated in closed systems. Thus, direct and indirect exposure of soil and soil organisms during manufacturing and formulation is practically negligible.  

2) Use of formulated HAT-ISO is also unlikely to result in direct and indirect exposure of soil and soil organisms. During use HAT-ISO is included in three-dimensional matrices of polymeric, resinous material and completely retained. Therefore, the direct and indirect release of HAT-ISO to soil and soil organisms is practically negligible. Therefore, direct and indirect exposure of HAT-ISO to soil is highly unlikely and performance of a test for toxicity to soil organisms is scientifically not justified. The Chemical Safety Assessment does not indicate the need to investigate toxicity to soil organisms further. For more details on exposure assessment see risk assessment report in section 13.