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Diss Factsheets

Administrative data

Description of key information

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 applied.

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)

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
lack of details on test substance
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Test was done before LLNA as first-choice method for in-vivo testing was set into force.
Species:
guinea pig
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
5%
No. with + reactions:
0
Total no. in group:
20
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
5%
No. with + reactions:
0
Total no. in group:
20
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
5%
No. with + reactions:
1
Total no. in group:
20
Clinical observations:
slight redness
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
5%
No. with + reactions:
0
Total no. in group:
20
Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
Test was done before LLNA as first-choice method for in-vivo testing was set into force.
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
According to Guideline.
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
Induction: 12.5%
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
Challenge: 6.25%
No. of animals per dose:
Test group: 20
Control group: 10
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
6.25%
No. with + reactions:
2
Total no. in group:
10
Clinical observations:
One animal showed as well a reaction when challenged with sterile water.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
6.25%
No. with + reactions:
0
Total no. in group:
10
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
6.25%
No. with + reactions:
4
Total no. in group:
20
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
6.25%
No. with + reactions:
2
Total no. in group:
19
Clinical observations:
One animal died accidentially on Day 29.
Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

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 [1] and by a voluntary industry program carrying out Human and Environmental Risk Assessments (HERA [2]), further supporting the read across approach between structurally related AS.

 

Skin sensitisation

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.

 

[1] SIDS initial assessment profile, (2007); http://www.aciscience.org/docs/Alkyl_Sulfates_Final_SIAP.pdf

[2] (HERA Draft report, 2002); http://www.heraproject.com/files/3-HH-04-%20HERA%20AS%20HH%20web%20wd.pdf

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

Study not required according to Annex VII-X of Regulation (EC) No 1907/2006.

Justification for classification or non-classification

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.