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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Link to relevant study record(s)

Reference
Endpoint:
basic toxicokinetics
Type of information:
other: written assessment
Adequacy of study:
key study
Study period:
not applicable
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Assessment of GLKP compliant data available for the sdubstance and/or read across
Objective of study:
toxicokinetics
Qualifier:
no guideline followed
Principles of method if other than guideline:
Written assessment of the potential toxicokinetics of the substance based on an evaluation of availabe animal data for the substance and chemical characteristics.
GLP compliance:
no
Radiolabelling:
no

The substance is a small aromatic sulphonic acid sodium salt of molecular weight that is likely to not preclude absorption.  Indeed, the physico chemical properties of the substances, principally water solubility and partition coefficient, would suggest that the substance is likely to be highly absorbed, particularly by oral exposure. The substance is highly hydrophilic and is likely to be absorbed through the gastrointestinal tract. In addition, low molecular weight hydrophilic species may pass through aqueous skin pores following dermal exposure. The substance has a high melting point, suggesting that the substance would not have a high vapour pressure and is a non-respirable powder. The substance is hydrolytically stable.

 

Absorption:

Acute oral and dermal toxicity studies showed no significant toxicity, but exposure by the dermal route in particular shows evidence of absorption by this route. Results of the acute skin irritation study also suggest that the substance is absorbed dermally, likely through hydrophilic activity. In a repeated dose oral toxicity study there is evidence of adsorption, likely through the gastrointestinal tract. The substance is highly water soluble and has a molecular weight which would not preclude crossing cell membranes, but the extremely low log Pow value would further suggest low lipophilicity. 

 

Distribution:

There is no experimental evidence to indicate distribution except, perhaps, to the kidney in the repeated dose oral toxicity study. Data from the necropsy in the 28-day repeat dose toxicity study demonstrates an increase in the relative weight of the kidneys suggesting adaptive changes associated with distribution of the substance in test animals. The extremely low Pow value obtained by testing and high water solubility suggests a low to negligible tendency to accumulation in lipid tissues.  

 

Metabolism:

The studies conducted provide no information about potential metabolism, but from the chemical structure, biotransformation of any absorbed substance would be expected to be low.  Increases in chloride levels in blood serum would suggest potential activity of the sodium cation in the gut with bile, partially supported by theslight hyperplasia and hyperkeratosis noted in stomach of high dose animals. 

 

Excretion:

The data available from the repeat dose toxicity test suggest that the principle mode of excretion would be via the kidneys in urine and faeces which is supported by the observation of changes to protein levels and pH in the urine of repeat dose toxicity test animals. As the material is expected to be non-volatile (based on QSAR assessment) there would be no basis to anticipate excretion via the lungs in expired air.

Conclusions:
Interpretation of results (migrated information): no bioaccumulation potential based on study results
Actual ADME data are not available, but on the basis of an evaluation of available data the substance is likely to be readily absorbed in the gut and excreted in urine and faeces.
Executive summary:

Actual ADME data are not available, but on the basis of an evaluation of available data the substance is likely to be readily absorbed in the gut and excreted in urine and faeces. The substance is considered not likely to bioaccumulate in lipid tissues.

Description of key information

Actual ADME data are not available, but on the basis of an evaluation of available data the substance is likely to be readily absorbed in the gut and excreted in urine and faeces.  The substance is considered not likely to bioaccumulate in lipid tissues.

Key value for chemical safety assessment

Bioaccumulation potential:
no bioaccumulation potential

Additional information