SUMILIZER GP

Long-term toxicity to fish

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 : Sumilizer GP

CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION
- Available GLP studies : not available
- Available non-GLP studies : not available
- Historical human/control data : not available
- (Q)SAR : Bioaccumulation data: VEGA 1.15: Meylan v1.0.3, CAESAR v2.1.14, Arnot-Gobas v1.0.0
- In vitro methods : No suitable in-vitro methods available
- Weight of evidence : No data available to submit a weight-of-evidence
- Grouping and read-across : No suitable source substances available with available chronic fish studies
- Substance-tailored exposure driven testing: not applicable
- Approaches in addition to above: not applicable
- Other reasons: 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 test item is poorly soluble in water. Therefore, in accordance with Column 2 of REACH Annex VIII and the “Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.7b: Endpoint specific guidance”, a long-term aquatic toxicity study on fish should be performed. A study according to OECD 210 is proposed since it should be regarded as the most suitable test guideline for addressing the information requirements related to fish long-term testing under REACH (Guidance document Chapter R.7b, ECHA 2017). The test will be conducted after a decision on the requirement to carry out the proposed test has been taken according to the procedure laid down in Regulation (EC) No 1907/2006 and a deadline to submit the information required has been set by the Agency.

FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- Details on study design / methodology proposed: The study should be conducted considering the OECD Guidance 23 for testing of poorly soluble and adsorptive substances.

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 210 (Fish, Early-Life Stage Toxicity Test)

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

442-450-4

EC Name:

-

Cas Number:

203255-81-6

Molecular formula:

C42H61O4P

IUPAC Name:

6-(3-(3-tert-Butyl-4-hydroxy-5-methylphenyl)propoxy)-2,4,8,1 0-tetra-tert-butyldibenz(d,f)(1,3,2)dioxaphosphepin