di-p-tolyl(2,4,6-trimethylbenzoyl)phosphine oxide

Repeated dose toxicity: oral

Administrative data

Endpoint:

sub-chronic toxicity: oral

Type of information:

experimental study planned

Justification for type of information:

TESTING PROPOSAL ON VERTEBRATE ANIMALS
[Please provide information for all of the points below. The information should be specific to the endpoint for which testing is proposed. Note that for testing proposals addressing testing on vertebrate animals under the REACH Regulation this document will be published on the ECHA website along with the third party consultation on the testing proposal(s).]

NON-CONFIDENTIAL NAME OF SUBSTANCE:
- Name of the substance on which testing is proposed to be carried out
Substance name: (di-p-tolylphosphoryl)(mesityl)methanone
CAS number: 270586-78-2

- Name of the substance for which the testing proposal will be used [if different from tested substance]
Substance name: (di-p-tolylphosphoryl)(mesityl)methanone
CAS number: 270586-78-2


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
- Historical human/control data
Not available
- (Q)SAR
Not available
- In vitro methods
Not available
- Weight of evidence
Not available
- Grouping and read-across
Not available
- Substance-tailored exposure driven testing [if applicable]
Not available
- Approaches in addition to above [if applicable]
Not available
- Other reasons [if applicable]
Not available

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:
- [free text] Not available

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

STUDY PLAN： SUBCHRONIC 90 DAY ORAL TOXICITY STUDY IN RATS (OECD 408)
WITH (di-p-tolylphosphoryl)(mesityl)methanone

The test item (di-p-tolylphosphoryl)(mesityl)methanone, in the vehicle (olive oil), will be administered by gavage once daily to three groups of Wistar Han male and female rats during 90 days in single dose volume of 4 mL.kg-1 body weight and euthanized on the 91st day of the study. A concurrent vehicle control group will receive the vehicle only (olive oil) on a comparable regime. Three treatment groups and one control group will consist of 10 health males and 10 health non-pregnant and nulliparous females. An additional satellite groups of 5 animals per sex will be used in the control and in the high dose groups, respectively. Satellite animals treated on the same regime will be subsequently used for 14-day post-treatment observation for the potential reversibility or persistence of any toxic effects.
All animals will be observed twice daily for mortality and morbidity and for signs of toxicity following dose administration. Detailed clinical observations, body weights, and food consumption will be recorded weekly.
Ophthalmological examinations will be performed in the pre-treatment period and at the end of in-life phase of the study in the all animals.
Functional observation data will be recorded at the week before scheduled killing. Ophthalmological examination and functional observations will be carried out in the all animals.
Clinical chemistry evaluations (serum chemistry and thyroid hormones analyses) and haematology examinations will be performed in all males and females at the end of the in-life phase of the study after overnight fasting.
Urinalysis determination will be performed in five animals per group/sex before scheduled euthanasia.
The animals of the treated groups will be euthanized following completion of the 90-day dosing period, the animals of satellite groups will be euthanized after 2-week recovery period.
Complete necropsies will be conducted in the all animals, and specified organs will be weighed. Selected tissues and lesions from all males and females will be examined microscopically in the vehicle control and high-dose groups, respectively, as well as in satellite groups, and from the animals that will be euthanized in extremis. Low dose and mid dose level groups will be evaluated for presumptive target organs and for macroscopic findings.

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)

Test material

Test material information

Constituent 1

Reference substance name:

[bis(4-methylphenyl)phosphoroso](2,4,6-trimethylphenyl)methanone

EC Number:

884-585-5

Cas Number:

270586-78-2

Molecular formula:

C24H25O2P

IUPAC Name:

[bis(4-methylphenyl)phosphoroso](2,4,6-trimethylphenyl)methanone