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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 irritation (OECD 404), rabbit: irritating
Read-across from source substances Sulfuric acid, mono-C12-18-alkyl
esters, sodium salts (CAS 68955-19-1)
Eye irritation (OECD 405), rabbit: highly irritating/corrosive
Read-across from source substance Sulfuric acid, mono-C12-16-alkyl
esters, sodium salts (CAS 73296-89-6)
SCLs according to Regulation (EC) No. 1272/2008 (CLP):
≥ 10% < 20% Eye Irrit. Cat. 2, H319
< 10% no classification
Table 1: Cell viability of the corrosion test
Exposure: 3 min
Exposure: 1 hour
Negative control (NC)
viability (% of NC)
Table 2: Cell viability of the irritation test
GHS Rating and Calculations
Six rabbits were divided into two treatment groups: 0.1 ml of a 50% w/w
solution of the test material B0010 (44% KAS paste) in distilled water
was instilled into one eye each of three rabbits (Group I); a second
group of three rabbits received the same treatment as group I, followed
at 4 seconds by a 20 ml lukewarm tap water rinse (Group II). The eyes
were examined for corneal opacity, iritis and conjunctivitis at one hour
and on days 1, 2, 3, 4, 7, 14, 21 and 28 following treatment and were
graded using Draize ocular irritation grading system.
All three eyes in Group I were assigned positive scores for corneal
opacity and ulceration, iritis, conjunctival redness and chemosis. Two
eyes were clear on day 28 of the study and showed signs of eye
irritation on day 21 of the study.
Three eyes in Group II were assigned positive scores for corneal
opacity. Three eyes were observed to have positive scores for
conjunctival redness and two for chemosis. In addition, two eyes were
assigned positive score for iritis. One eye was clear on day 3 and two
on day 21 of the study.
There is no study regarding skin and eye irritation/corrosion 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.
Regarding skin irritation one relevant key study is available for the
read-across substance C12-18 AS Na (CAS 68955-19-1) and three supporting
studies for C16-18 AS Na (CAS 68955-20-4).
One skin irritation study was conducted with C12-18 AS Na (CAS
68955-19-1, analytical purity 88.7%) according to OECD Guideline 404
under semi-occlusive conditions (BASF, 1994). Each of three New Zealand
White rabbits was exposed for 4 h to 0.5 g of the unchanged test item
and was observed for a period of 14 days for erythema and edema. The
mean erythema score (24, 48 and 72 h reading) and the mean edema score
were 3 and 2.3, respectively. Both effects were fully reversed within
the 14 days observation period. Thus the test substance was classified
as skin irritating, category 2, according to Regulation (EC) No.
1272/2008 (CLP) within this study.
A second study was conducted with C16-18 AS Na (CAS 68955-20-4,
analytical purity 55%) according to OECD guideline 404 on 5 rabbits
(strain: Kleinrusse Chbb:HM) (BASF, 1986a). 0.5 g of the unchanged test
item was applied for 4 h under occlusive conditions and skin reactions
were scored immediately, 24, 48 and 72 h after removal of the patch and
on day 7. The mean erythema score (24, 48 and 72 h reading) and the mean
edema score were 1.3 and 0.6, respectively. Both effects were fully
reversed within the 7 days observation period. Based on the result of
this study the test substance is not irritating at a concentration of
Another study with C16-18 AS Na (CAS 68955-20-4, analytical purity
94.3%) was performed according to OECD guideline 404 on 5 rabbits
(strain: Kleinrusse Chbb:HM) (BASF, 1987b) 0.5 mL of the diluted test
item (25%) was applied for 4 h under occlusive conditions to the rabbit
skin and skin reactions were scored immediately after removal of the
patch, after 24, 48 and 72 h and on day 7, 10, 14, 17 and 21. The mean
erythema score (24, 48 and 72 h reading) and the mean edema score were
1.6 and 0.7, respectively. Both effects were fully reversible during the
observation period. Based on the result of this study the test substance
is not irritating at a concentration of 25% a.i.
A combined OECD guideline 431 and OECD guideline 439 in vitro study with
reconstructed human epidermis (RHE) was performed with 25% C16-18 AS Na
(CAS 68955-20-4) (BASF, 2012b). When cells were exposed for 3 and 60
minutes without a post exposure period (corrosion test) the cell
viabilities were 103% and 107%, respectively. The cell viability after a
60 min exposure and 42 h post exposure period (irritation test) was
117%. Thus, 25% C16-18 AS Na was neither corrosive nor irritating in
this in vitro study.
Conclusion on the skin irritating properties of C16-20 AS Na (CAS
C12-18 AS Na (CAS 68955-19-1) contains in contrast to C16-20 AS Na (CAS
91648-55-4) up to 65 % C12 AS which represents the carbon chain length
with the highest irritation potential of the members of the AS Category.
However, no data within the category for C20 AS are available.
Therefore, this read-across is conservative and the hazard of the target
substance might be overestimated. According to Regulation (EC) No.
1272/2008 (CLP) ≥ 10% C16-20 AS Na (CAS 91648-55-4) needs to be
classified as H315, Skin Irrit. 2. No classification is required below
10% C16-20 AS Na (CAS 91648-55-4).
No data are available for the neat substance allowing a definitive
classification of C16-20 AS Na (CAS 91648-55-4). Therefore, a
read-across from C12-16 AS Na (CAS 73296-89-6).
An OECD guideline 405 study was performed with 0.1 mL pure C12-16 AS Na
(CAS 73296-89-6, analytical purity 30%) on three New Zealand White
rabbits (KAO, 1997). The observation period was 21 days. Eye reactions
were scored 1, 24, 48 and 72 h after treatment. Further observations
were performed on days 7, 14, and 21 after application. The mean (24, 48
and 72 h reading) cornea, iris, conjunctivae and chemosis scores were 1,
0.2, 2.8 and 3.6. The iritic effects reversed within 72 h and chemosis
within the 21 day observation period. The effects observed on cornea and
the redness of the conjunctiva was not fully reversible within 21 days.
Thus the substance produced irreversible effects on the eye at a
concentration of 30% within this study.
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, studies with C16-18
AS Na (CAS 68955-20-4), C12-13 AS K (CAS 91783-22-1) and C10-16 AS Na
(CAS 68585-47-7) with a concentration range of 10 to 25% were evaluated.
In an OECD guideline 405 study 0.1 mL of a 25% aqueous solution of
C16-18 AS Na (CAS 68955-20-4) was applied to one eye of each of four
rabbits (BASF, 1987c). Eye reactions were scored 1, 6, 24, 48 and 72 h
and 1, 10, 14, 17 and 21 days after application. The mean (24, 48 and 72
h reading) cornea, iris, conjunctivae and chemosis scores were 0.8, 0,
2.3 and 0.4. All effects were fully reversible. The test substance meets
the classification criteria of Regulation (EC) No 1272/2008 (Eye
Irritating Cat 2). Thus, the results of this study indicate the
concentration of 25% used within this study to be the borderline for
classification purposes under CLP.
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 (P&G, 1978b) without rinsing. 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 four 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 eye
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
(Stephan, 1980a) on three New Zealand White rabbits with an observation
period of seven days. 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 (Stephan, 1980b). 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 C16-20 AS Na (CAS
Based on the above mentioned results with different concentrations of
structurally related alkyl sulfates a cut-off 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% C16-20 AS Na (CAS
According to Regulation (EC) No. 1272/2008 (CLP) ≥ 20% C16-20 AS Na (CAS
91648-55-4) needs to be classified as H318, Eye Dam. 1. Based on a
weight of evidence approach ≥ 10 % - < 20% C16-20 AS Na (CAS 91648-55-4)
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
 SIDS initial assessment profile, (2007);
 (HERA Draft report, 2002);
According to the classification criteria of Regulation (EC) No.
1272/2008 (CLP) 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, respectively) 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
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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