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EC number: 293-917-2
CAS number: 91648-55-4
No data are available for the target substance Sulfuric acid,
mono-C16-20 (even numbered)-alkyl esters, sodium salts (CAS 91648-55-4).
Therefore, read-across from structural analogue substances has been
Skin sensitisation (Buehler - OECD 406): not sensitising
Read-across from source substance Sulfuric acid, mono-C12-18-alkyl
esters, sodium salts (68955-19-1)
Skin sensitisation (GPMT - OECD 406): not sensitising
Read-across from source substance Sulfuric acid, mono-C16-18-alkyl
esters, sodium salts (68955-20-4)
There is no study regarding sensitisation available for C16-20 AS Na
(CAS 91648-55-4). Therefore, this endpoint is covered by read-across to
structurally related alkyl sulfates (AS). The possibility of a
read-across to other alkyl sulfates in accordance with Regulation (EC)
No 1907/2006 Annex XI 1.5 “Grouping of substances and read-across
approach” was assessed. In Annex XI 1.5 it is given that a read-across
approach is possible for substances whose physicochemical, toxicological
and ecotoxicological properties are likely to be similar or follow a
regular pattern as a result of structural similarity. The AS reported
within the AS category show structural similarity. The most important
common structural feature of the category members is the presence of a
predominantly linear aliphatic hydrocarbon chain with a polar sulfate
group, neutralized with a counter ion. This structural feature confers
the surfactant properties of the alkyl sulfates. The surfactant property
of the members of the AS category in turn represent the predominant
attribute in mediating effects on mammalian health. Therefore, the AS of
the AS category have similar physicochemical, environmental and
toxicological properties, validating the read across approach within the
category. The approach of grouping different AS for the evaluation of
their effects on human health and the environment was also made by the
OECD in the SIDS initial assessment profile  and by a voluntary
industry program carrying out Human and Environmental Risk Assessments
(HERA ), further supporting the read across approach between
structurally related AS.
There is one study regarding skin sensitisation with C16-18 AS Na (CAS
68955-20-4) and a second study with C12-18 AS Na (CAS 68955-19-1)
available. Both studies are
accounted for in a Weight-of-Evidence (WoE) approach.
The skin sensitizing potential of C16-18 AS Na (CAS 68955-20-4,
analytical purity 55%) was assessed in a Guinea Pig Maximisation Test
according to OECD Guideline 406 (BASF, 1986c). In this study guinea pigs
were induced by intradermal and epicutaneous application of the test
item at concentrations of 0.01% (intradermal induction) and 10%
(epicutaneous induction). Challenge was performed with 5% after 14 days.
Water was used as vehicle. 1/20 (5%) animals treated with the test item
and 0/20 animals of the control group showed a positive reaction at the
24 h reading after challenge. At the second reading (48 h after
challenge) no skin reactions were observed. Thus, the test item showed
no significant sensitising potential within this study.
In a second study, the skin sensitizing potential of C12-18 AS Na (CAS
68955-19-1, analytical purity 100%) was assessed in a Buehler Test
according to OECD Guideline 406 under occlusive conditions (BASF, 1996).
In this study, 20 guinea pigs of the treatment group were induced three
times via epicutaneous application of a 12.5% aqueous solution of the
test item for 6 h at an interval of 7 days. The procedure was also
performed on 10 animals of the control group with water as inducing
agent. Challenge was performed 7 days after the last induction treatment
for 6 h at a concentration of 6.25% on all animals (treated and
control). Animals of the control group were additionally challenged with
water on the opposite flank. Each challenge site was examined 24 and 48
h after removal of the challenge patch. At the 24 h reading skin
reactions of the control group were observed on 2/10 (20%) guinea pigs
at the site challenged with the test item. Skin reactions were also
observed on one of these animals on the site challenged with water
(10%). No skin reaction was observed at the second reading on any animal
of the control group. Skin reactions were seen in 4/20 (20%) animals
after 24 h and on 2/19 (10%) animals after 48 h in the treatment group.
Thus, C12-18 AS Na (CAS 68955-19-1) is not a skin sensitiser.
Based on the above mentioned results, the data of the read-across
substance C16-18 AS Na (CAS 68955-20-4) and C12-18 AS Na (CAS
68955-19-1) indicates no skin sensitisation potential. Therefore, C16-20
AS Na (CAS 91648-55-4) is not expected to be a skin sensitiser.
Moreover, alkyl sulfate, i.e. sodium lauryl sulfate (C12 AS Na) is
recommended as an agent to induce local irritation in a method to assess
skin sensitising properties of chemicals (OECD guideline 406, Guinea Pig
Maximisation Test). Hence, there is a lot of experience with sodium
lauryl sulfate in sensitising studies and no evidence occurred that it
shows sensitising properties. Thus, skin sensitisation by members of the
alkyl sulfates is generally unlikely.
 SIDS initial assessment profile, (2007);
 (HERA Draft report, 2002);
Study not required according to Annex VII-X of Regulation (EC) No
The available data on skin sensitisation do not meet the criteria
for classification according to Regulation (EC) No. 1272/2008 (CLP) and
are therefore conclusive but not sufficient for classification.
No data available for respiratory sensitisation.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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