Registration Dossier

Administrative data

dermal absorption
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Expert judgement combined with experimental data. According to the ECHA guidance document “Practical guide 6: How to report read-across and categories (March 2010)”, the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.

Data source

Reference Type:
secondary source
Human & Evironmental Health Risk Assessment on ingredients of European household cleaning products. Alkyl Sulphates. Environmental Risk assessment. 07 March 2002
Bibliographic source:

Materials and methods

Principles of method if other than guideline:
No guideline exists for this type of appraisal.
GLP compliance:

Test material

Details on test material:
Various, for details see HERA report and SIDS
other: partly

Test animals

other: human, rat, guinea-pig
Details on test animals and environmental conditions:
not applicable

Administration / exposure

Type of coverage:
other: Various, for details see HERA report and SIDS
not specified
Duration of exposure:
Various, for details see HERA report and SIDS
Various, for details see HERA report and SIDS
No. of animals per group:
Various, for details see HERA report and SIDS

Results and discussion

Absorption in different matrices:
Absorption by the percutaneous route is limited, since anionic surfactants tend to bind to the skin surface (Howes, 1975; Black and Howes, 1980). Early studies with isolated human skin were unable to detect penetration of a homologous series of AS, ranging from C8 to C18 (Blank and Gould, 1961). Animal studies confirmed a low level of percutaneous absorption of AS. Less than 0.4% of a 3 μmol dose of 35S-labeled C12AS-Na was percutaneously absorbed in guinea pigs, based on recovery of the radiolabel in urine, faeces and expired air (Prottey and Ferguson, 1975). Studies with rats indicated that pre-washing of the skin with surfactant enhanced AS skin penetration (Black and Howes, 1980).

For consumer exposure, actual dermal absorption is below 1% (Rice, 1977) or very low (Schäfer and Redelmeier, 1996), therefore a default assumption of 1% dermal absorption was taken for deriving the DNEL. Since the dermal absorption decreases with increasing concentration of a solution this percentage can be expanded to workers as a worst case approach.
Conversion factor human vs. animal skin:
not applicable

Applicant's summary and conclusion