Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Endpoint:
basic toxicokinetics
Type of information:
other: estimation
Adequacy of study:
key study
Study period:
15 June 2012
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: No experimental data are available. Estimations on toxicokinetics were made based on the available guidance.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012

Materials and methods

Principles of method if other than guideline:
A statement was prepared based on the guidance on the information requirements and chemical safety assessment.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
1,5,2,4-dioxadithiane 2,2,4,4-tetraoxide
EC Number:
700-464-0
Cas Number:
99591-74-9
Molecular formula:
C2H4O6S2
IUPAC Name:
1,5,2,4-dioxadithiane 2,2,4,4-tetraoxide
Details on test material:
Not applicable.

Test animals

Species:
other: Not applicable
Details on test animals or test system and environmental conditions:
Not applicable.

Administration / exposure

Route of administration:
other: not applicable.
Vehicle:
other: not applicable.
Details on exposure:
Not applicable.
Duration and frequency of treatment / exposure:
Not applicable.
Doses / concentrations
Remarks:
Doses / Concentrations:
Not applicable.
No. of animals per sex per dose / concentration:
Not applicable.
Control animals:
other: Not applicable.
Positive control reference chemical:
Not applicable.
Details on study design:
Not applicable.
Details on dosing and sampling:
Not applicable.
Statistics:
Not applicable.

Results and discussion

Preliminary studies:
Not applicable.

Toxicokinetic / pharmacokinetic studies

Details on absorption:
Not applicable.
Details on distribution in tissues:
Not applicable.
Details on excretion:
Not applicable.

Metabolite characterisation studies

Details on metabolites:
Not applicable.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): other: no bioaccumulation, due to hydrolytical unstability.
MMDS is a solid and is hydrolytically unstable in water and aqueous solutions. Physical chemical characteristics of MMDS requiring studies in aqueous surroundings (as water solubility, octanol/water partition coefficient and surface tension) can therefore not be determined on MMDS. MMDS will decompose rapidly in formaldehyde and MSDA. As the assessment will be performed for MMDS, the toxicokinetic behavior of MSDA and formaldehyde is not further considered.

As the physical chemical properties of the substance determine the toxicokinetic properties of MMDS for a toxicokinetic assessment, and the essential values for MMDS are not available, worst-case estimates are proposed for MMDS, according to REACH guidance (1,2).

For oral absorption, the worst-case value is considered 50% (2). The results of the toxicity studies do not provide reasons to deviate from this proposed oral absorption factor.

Based on the particle size of MMDS, the mass median aerodynamic diameter of MMDS is 192.481 µm. Particles < 100 μm which have a potential to be inhaled, are present (10% < 59.316 µm and 2.26% < 10 µm). For risk assessment purposes in the scope of EU REACH, the inhalation absorption of MMDS is set at 100%, as a worst-case estimate (1,2).

Based on the relatively low molecular weight (188.179) and in the absence of a logPow, the criteria for 10% dermal absorption as given in the guidance (1) (MW > 500 and logPo/w > 4) are not met and hence 100% dermal absorption is proposed. The results of the toxicity studies do not provide reasons to deviate from this proposed dermal absorption factor.
Normally, it is generally accepted that dermal absorption is lower compared to oral absorption. However, since the 50% oral absorption is set in absence of further data, the 100% dermal absorption should therefore be considered a worst case assumption.