Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
fish early-life stage toxicity
Type of information:
experimental study planned
Justification for type of information:
TESTING PROPOSAL ON VERTEBRATE ANIMALS

NON-CONFIDENTIAL NAME OF SUBSTANCE:
- T1063FM

CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION [please address all points below]:

- Available GLP studies: not available
- Available non-GLP studies: not available
- (Q)SAR: no reliable QSAR predictions available
- In vitro methods: no in vitro results available
- Weight of evidence: available data do not allow a weight of evidence approach.
- Grouping and read-across: no suitable data for analogous substances to the test substance are available.
- Substance-tailored exposure driven testing [if applicable]: not applicable
- Approaches in addition to above [if applicable]: not applicable

CONSIDERATIONS THAT THE SPECIFIC ADAPTATION POSSIBILITIES OF ANNEXES VI TO X (AND COLUMN 2 THEREOF) OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
- The Board of Appeal's decision (A-011-2018) from 4 May 2020 states that REACH Annex IX (section 9.1, column 2) does not allow registrants to omit information on long-term toxicity to fish under column 1. Furthermore, the decision overrides advice given in the ECHA Guidance. This means that as a consequence, information on aquatic toxicity described in ECHA’s Guidance on Information Requirements and Chemical Safety Assessment related to REACH Annex IX, section 9.1, Column 2 as a waiver for the information requirement under Column 1 is no longer valid.


FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- ECHA considers the fish early-life stage toxicity test using the OECD TG 210 as the most appropriate and suitable.

Data source

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 210 (Fish, Early-Life Stage Toxicity Test)

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
457-330-7
EC Name:
-
Cas Number:
66034-17-1
Molecular formula:
Hill formula: C4H10N2:H4O7P2 CAS formula: C4H10N2:H4O7P2
IUPAC Name:
(phosphonooxy)phosphonic acid; piperazine
Test material form:
solid: particulate/powder

Results and discussion

Applicant's summary and conclusion