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Administrative data

Endpoint:
basic toxicokinetics in vivo
Type of information:
not specified
Adequacy of study:
weight of evidence
Reliability:
1 (reliable without restriction)
Justification for type of information:
The assessment is based on the REACH Annex VIII provisions and ECHA's Guidance on information requirements and chemical safety assessment R.7c: Endpoint specific guidance (ECHA, June 2017).

Data source

Reference
Reference Type:
other: expert statement
Title:
Unnamed
Year:
2018
Report date:
2018

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Expert statement according to REACH Annex VIII (section 8.8.1) provision: assessment of the toxicokinetic behaviour of the substance to the extent that can be derived from the relevant available information
GLP compliance:
no
Remarks:
this is an expert statement, however based on data generated under GLP

Test material

Constituent 1
Chemical structure
Reference substance name:
Phosphoric acid, mixed esters with alcohols, C7-9-iso-, C8-rich and alcohols, C11-14-iso-, C13-rich, ethoxylated, potassium salt
EC Number:
947-738-8
Molecular formula:
Molecular formulas of exemplary components: C33H68KO10P C49H100KO16P C24H49K2O10P C24H50KO10P C16H34KO4P C8H17K2O4P C8H18KO4P
IUPAC Name:
Phosphoric acid, mixed esters with alcohols, C7-9-iso-, C8-rich and alcohols, C11-14-iso-, C13-rich, ethoxylated, potassium salt
Test material form:
liquid

Results and discussion

Toxicokinetic / pharmacokinetic studies

Details on absorption:
The substance is a mixture of mono and di-potassium salts of various phosphate esters of alcohols C7-9-iso, C8-rich and C11-14-iso, C13-rich, ethoxylated. Molecular weights of particular components are within a range from approx. 248 to approx. 1020 Da. Molecules with a molecular weight below 500 Da (approx. 50% of the substance) are generally well absorbed, while molecular weights above 500 Da do not favor absorption (relatively large particle).

As the most favorable values of partition coefficient for absorption are between -1 and 4, and many of the components of this UVCB substance have log Kow (estimated) within this range (some are more hydrophilic with log Kow of approx. -2), oral and dermal adsorption can be anticipated and the substance may dissolve in GI fluids, as well as in blood. Additionally, surfactant properties of the substance causing skin corrosion may increase likelihood of dermal penetration.

Vapour pressure of the substance and all its components is very low, therefore inhalation route would not be of first concern for absorption of the actual substance.
Details on distribution in tissues:
Adverse effects were found in liver and kidneys of animals orally dosed 750 mg/kg b.w. (HD), which is insufficient however for classification. It may be anticipated the substance is being distributed systematically. The highest estimated value of BCF among all constituents amounts to 2.75 log L/kg(wet). This means there is a low risk of accumulation in fat.
Details on excretion:
Due to the substance constituents various molecular weights (small and large molecules) and partition coefficient values (more or less hydrophilic) it can be anticipated both urinary route (small molecules, hydrophilic) and excretion via bile (large molecules, hydrophobic) will play a role. Portion of the substance not being absorbed will be excreted with feces.

Metabolite characterisation studies

Metabolites identified:
no
Details on metabolites:
No significant changes in genotoxicity studies were found after addition of S9 fraction.

Applicant's summary and conclusion

Conclusions:
Properties of the substance indicate a possibility of absorption through oral and dermal route in particular. Inhalation route is of lower concern. The substance will be probably excreted with urine, bile and feces. Adverse effects were observed in liver and kidneys of HD animals in the OECD 422 study (750 mg/kg b.w.). This does not allow for substance classification though.

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