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EC number: 282-968-6
CAS number: 84501-49-5
skin irritation (OECD 404): irritatingeye irritation (worst case assumption): highly irritating/corrosiveSCLs according to GHS:>=10% - <20% Eye Irrit. Cat.2, R36<10% No Classification
There is no study regarding skin and eye
irritation/corrosion available for C9-11 AS Na (CAS 84501-49-5).
Therefore this endpoint is covered by read across to structurally
related alkyl sulfates (AS), i.e.C8 AS Na (CAS 142-31-4) and C12 AS Na
(CAS 151-21-3) for skin irritation and C10-16 AS Na (CAS 68585-47-7) and
C12-13 AS K (CAS 91783-22-1) for eye irritation.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 programme carrying out Human and Environmental Risk Assessments
(HERA ), further supporting the read across approach between
structurally related AS.
Regarding skin irritation one relevant study is
available for the read-across substances C8 AS Na (CAS 142-31-4) and C12
AS Na (CAS 151-21-3).
In an OECD guideline 404 study, C8 AS Na (CAS
142-31-4, analytical purity 92.5%) was applied to 3 New Zealand rabbits
under semi-occlusive conditions for 4 h (BASF, 2012c). Skin reactions
were scored 1, 24, 48 and 72 h. The observation period was 14 d.
Clinical observations comprised of scaling to severe scaling,
incrustations, eczema like lesions, bloody, yellowish incrustations,
yellowish discoloration of application site and plaque like
incrustations. The mean erythema score after 24, 48 and 72 h was 3 for
each rabbit. The mean edema scores after 24, 48 and 72 h were 2, 3.3 and
3 for animals 1, 2 and 3, respectively. Erythema and edema were not
fully reversible within 14 d. Thus the test substance was classified as
skin irritating Category 2 according to Regulation 1272/2008/EC.
The study conducted with C12 AS Na (CAS 151-21-3,
analytical purity 100%) was performed similar to OECD Guideline 404
under occlusive conditions (Esposito, 1976). Each of six New Zealand
White rabbits was exposed for 24 h to 0.5 mL of the unchanged test item
and was observed for a period of 72 h for erythema and edema. The 48 h
reading time point was missing. The mean erythema and edema score after
24 and 72 h were 2.2 and 1.7. Both were not reversible within 72 h. When
using the higher value of the 24 and 72 h reading time point as value
for the 48 h value (per animal) the mean erythema and edema score of all
animals were 2.4 and 2.2, respectively. Thus the test substance was
classified as skin irritating Category 2 according to Regulation
Conclusion on the skin irritating properties of
C9-11 AS Na (CAS 84501-49-5)
Based on the results mentioned above the data on
the read across substances justify a classification of C9-11 AS Na (CAS
84501-49-5) for skin irritation. According to CLP ≥ 10% C9-11 AS
Na (CAS 84501-49-5) needs to be classified as H315, Skin Irrit. 2. No
classification is required below 10% C9-11 AS Na (CAS 84501-49-5).
No data are available for the neat substance
allowing a definitive classification of C9-11 AS Na (CAS 84501-49-5).
However, there are several studies investigating the eye irritating
potential of alkyl sulfates (AS) which have shown that AS concentrations
of 10% and higher are moderately to strongly irritating to rabbit eyes
and that formulations containing more than 20% AS can cause serious eye
damage. Unless data are available that show absence of the irritating
potential as defined by the EC criteria the classification Eye Dam. 1,
H318 according to Regulation (EC) 1272/2008 will be applied for the neat
Setting of SCLs for eye irritation
As corrosion and irritation depends on the
concentration of the substance in a solvent, further studies with lower
concentrations of the read across substances were also considered to
assess whether specific concentration limits can be set.
For this purpose a read across to structurally
related AS, i.e C12-13 AS K (CAS 91783-22-1) and C10-16 AS Na (CAS
68585-47-7) with a concentration range of 10 to 22% was performed
In the study with C12-13 AS K (CAS 91783-22-1,
analytical purity 44%) 0.1 mL of the diluted test item (1:1 mixture with
water) was applied to one eye of each of three New Zealand White rabbits
according to OECD guideline 405 without rinsing (Braun, 1978). In a
second experiment with additional 3 rabbits the procedure was repeated
but the treated eye was rinsed with 20 mL of lukewarm tap water 4
seconds after application of the test item. The eye reactions were
recorded 1, 24, 48, 72 h and 4, 7, 14, 21 and 28 days in both
experiments. The mean (24, 48 and 72 h reading) cornea, iris,
conjunctivae and chemosis scores of experiment 1 were 2, 0.8, 2.1 and
1.7. The findings reversed in 2/3 animals within 14 days while 1/3
animals showed signs of irritation after 21 days. However, the signs of
irritation show a clear tendency to decrease with time. No reading on
day 28 was possible. Findings in the experiment with rinsing of the eye
were less pronounced but irritating properties were also observed. As
the ocular findings clearly reversed within 21 days the result of the
study indicate the concentration of 22% to be the turning point between
classification as severe damage to the eye and reversible eye damaging.
The first study with 0.1 mL undiluted C10-16 AS Na
(CAS 68585-47-7, analytical purity 10%) was performed similar to OECD
guideline 405 on three New Zealand White rabbits with an observation
period of 7 days (Kukulinski, 1980). The mean (24, 48 and 72 h reading)
cornea, iris, conjunctivae and chemosis scores over all animals were
1.4, 0.7, 2 and 1.6. Corneal opacity was still observed in 1/3 animals
(scored 1) and conjunctival redness was still present in 2/3 animals
(both scored 1) upon reading at day 7. Depending on the classification
requirements the test substance is not or only moderate irritating to
the eye at a concentration of 10%.
The second study with C10-16 AS Na (CAS 68585-47-7,
analytical purity 10%) was performed similar to OECD guideline 405
(Kukulinski, 1980). 0.1 mL of the undiluted test item was instilled into
one eye of each of three New Zealand White rabbits. Eye reactions were
scored at least 24, 48 and 72 h and 14 days after application of the
test item. The mean (24, 48 and 72 h reading) cornea, iris, conjunctivae
and chemosis scores were 0.9, 0.7, 1.9 and 1.6. All findings were fully
reversible within the observation period. Thus, the test substance
showed no eye irritating properties at a concentration of 10%.
Conclusion on the eye irritating properties of
C9-11 AS Na (CAS 84501-49-5)
Based on the above mentioned results with different
concentrations of structurally related alkyl sulfates a cut of value for
classification as severe irritating to eyes is set at a concentration of
20% and for classification as irritating at a concentration of 10%.
Since the available data of the read-across substance C10-16 AS Na (CAS
68585-47-7) indicates no eye irritation potential at a concentration of
10%, no classification is required below 10% C9-11 AS Na (CAS
According to CLP ≥ 20% C9-11 AS Na (CAS 84501-49-5)
needs to be classified as H318, Eye Dam. 1. Based on a weight of
evidence approach ≥ 10 % - < 20% C9-11 AS Na (CAS 84501-49-5) needs to
be classified as H319, Eye Irrit. 2 according to CLP. Below 10% no
classification at all is required.
No data on respiratory irritation are available. AS
is mainly used in liquid media and due to its very low vapour pressure
 inhalation is not viewed as a significant route of exposure.
Inhalation of AS may occur by inhalation of aerosols generated by spray
cleaners or by inhalation of detergent dusts (e.g. washing powder). In
both cases the substance will be used in low concentrations. However in
case the substance is available as neat powder the substance will also
be classified as STOT Single exp. Cat 3 according to CLP at
concentrations exceeding 20%
 SIDS initial assessment profile, (2007);
 (HERA Draft report, 2002);
According to the classification criteria of
Regulation (EC) No 1272/2008 the test substance needs to be classified
with Skin Irritation Category 2, H315 and Eye Dam.1, H318, respectively.
As the neat substance has to be classified as skin irritating, the
substance will also be classified as “may cause respiratory irritation”
(STOT SE3, H335) in case the substance is available as neat powder.
It could be shown with experimental data on eye
irritation that at 10 to 20% active substance only the classification
Eye Irritating Category 2 according to Regulation (EC) No 1272/2008
remains. Below 10% active substance no classification at all is
necessary. Hence, the Generic Concentration Limits (GCLs) can be
substituted by the mentioned specific ones (SCLs).
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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