Bis(2-hydroxyethyl) sulphone

Basic toxicokinetics

Administrative data

Endpoint:

basic toxicokinetics, other

Type of information:

other: In accordance with REACH Annex VIII (8.8) an assessment of toxicokinetic behavior has been conducted to the extent that can be derived from the relevant available information.

Adequacy of study:

key study

Study period:

The assessment was conducted in May 2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Relevant studies were reviewed by a qualified toxicologist with a view to fulfilling the requirements of Annex VIII (8.8).

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Materials and methods

Objective of study:

toxicokinetics

Test guideline

Qualifier:

no guideline required

Principles of method if other than guideline:

In accordance with REACH Annex VIII (8.8) an assessment of toxicokinetic behaviour has been conducted to the extent that can be derived from the relevant available information. The assessment is based on the Guidance on information requirements and chemical safety assessment R.7c: Endpoint specific guidance (ECHA, November 2014)

GLP compliance:

no

Remarks:

Not relevant for assessment

Test material

Test material information

Constituent 1

Reference substance name:

Bis(2-hydroxyethyl) sulphone

EC Number:

219-948-3

EC Name:

Bis(2-hydroxyethyl) sulphone

Cas Number:

2580-77-0

Molecular formula:

C4H10O4S

IUPAC Name:

2-(2-hydroxyethanesulfonyl)ethan-1-ol

Test material form:

solid

Specific details on test material used for the study:

Sponsor’s identification: Bis(2-hydroxyethyl) sulphone
Description: White solid Block
CAS Number: EC 219-948-3

Results and discussion

Any other information on results incl. tables

TOXICOKINETIC BEHAVIOUR:

Absorption

The test item is a relatively low molecular weight solid block that is readily soluble in water and has a low log Octanol: Water partition coefficient. This suggests that the test item has the potential to cross biological membranes, via diffusion, such as those of the gastro-intestinal tract following oral ingestion. Some more limited passage across the dermal barrier may be possible. As the material does not exist as particulates and the material is not volatile, inhalation of the material is not expected. The results of the acute and repeated dose toxicity studies show no significant evidence of toxicity there is little to confirm that there has been significant absorption of the test item; or the test item is not inherently toxic.

Distribution

As the test item is of low molecular weight and is water soluble, it can be assumed that any absorbed test item can be readily distributed in the water fraction of circulatory fluids. The lack of skin sensitization response would suggest the material does not bind to circulatory proteins. The limited fat solubility suggests the material is unlikely to accumulate in body fat

Metabolism

The results of the repeat dose toxicity/screening reproduction study shows no evidence of enhanced hepatic metabolism and the fact that the material is already freely water soluble suggests that metabolism may not be required to enhance excretion. Genotoxicity studies in vitro show that the genotoxic potential of the test item is neither enhanced nor diminished in the presence of S9 microsomal metabolising system.

Excretion

Low molecular weight test items that are water soluble are most likely to be excreted via the kidney although the repeat dose toxicity/reproduction screening study gives no indication of route of excretion. Following oral ingestion, any test item that is not absorbed is likely to be excreted in the faeces

Applicant's summary and conclusion

Conclusions:

The test item is a low molecular weight solid that is water soluble. Any oral ingestion of the test item may lead to absorption and systemic distribution. The test item is unlikely to be metabolised and excretion is most likely to be via the kidney

Executive summary:

The test item is a low molecular weight solid that is water soluble. Any oral ingestion of the test item may lead to absorption and systemic distribution. The test item is unlikely to be metabolised and excretion is most likely to be via the kidney