Registration Dossier

Ecotoxicological information

Long-term toxicity to aquatic invertebrates

Administrative data

Endpoint:
long-term toxicity to aquatic invertebrates
Type of information:
experimental study planned (based on read-across)
Justification for type of information:
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
See attached document in IUCLID Section 13 - Read across_fin

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
See attached document in IUCLID Section 13 - Read across_fin

3. ANALOGUE APPROACH JUSTIFICATION
Using a technique Read across to predict endpoint information for Humic acids, sodium salts by using data from the same endpoint from source chemicals – Humic acids, potassium salts is appropriate based on similarities in general molecular structure of humic acids (the source of substances) as such and functionality of their water soluble salts. Production of sodium or potassium salts is only necessary for increase of bioavailability of humic acids. Given that both the source substance and the target substance is produced entirely in the same manner (source of oxyhumolite for both registered substances is the same and substances are manufactured exactly in the same manner) and have comparable results in available studies, which did not lead to classification, it is expected that the results from long-term study on the target substance will not provide significantly different information. Therefore it is concluded as unnecessary to perform long-term toxicity to aquatic invertebrates study for Humic acids, sodium salts and use the read-accross prinsiple to describe the properties.

4. DATA MATRIX
See attached document in IUCLID Section 13 - Table 1: Data matrix

Data source

Materials and methods

Principles of method if other than guideline:
The information requirement will be filled by read-accross principle from study proposed for structural analogue - Humic acids, potassium salts, which is proposed.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Humic acids, sodium salts
- Molecular formula: not known - UVCB substance
- Molecular weight: not known - UVCB substance
- Substance type: technical product
- Physical state: solid
- Lot/batch No.: 9. 5. 2007/R
- Expiration date of the lot/batch: 05/2022
- Stability under test conditions: stable
- Storage condition of test material: dry conditions


Results and discussion

Applicant's summary and conclusion