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:
- Name of the substance on which testing is proposed to be carried out: Urea Sulphate
- Name of the substance for which the testing proposal will be used [if different from tested substance]

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: no studies exist.
- Available non-GLP studies: no studies exist.
- Historical human/control data: no studies exist.
- (Q)SAR: most of the (Q)SAR models are developed for organic chemicals and do not address the specificity of some types of chemicals such as ionisable substances
- In vitro methods: no results for long-term toxicity exist for the source data
- Weight of evidence: there is no enough weight of evidence to get a reasoned justification
- Grouping and read-across: no data from source substances exist
- Substance-tailored exposure driven testing [if applicable]: not applicable
- Approaches in addition to above [if applicable] : not applicable
- Other reasons [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:
- No data from source substances exist in order to make a read-across so, it is neccesary to investigate further the effects on aquatic organisms since the substance is used as fertilizer.

FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- Details on study design / methodology proposed [if relevant]

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:
Urea sulphate
EC Number:
242-803-0
EC Name:
Urea sulphate
Cas Number:
19082-42-9
Molecular formula:
CH4N2O.xH2O4S
IUPAC Name:
sulfuric acid; urea

Results and discussion

Effect concentrations
Duration:
48 h
Dose descriptor:
NOEC

Applicant's summary and conclusion