Registration Dossier

Administrative data

Description of key information

No data are available for the target substance Alcohols, C12-14, ethoxylated (1-2.5 EO), sulfates, triethanolammonium salts (CAS 157627-94-6). Therefore, read-across from structural analogue substances has been applied.

skin sensitization (OECD 406): not sensitizing

Read-across from structural analogue source substances Alcohols, C12-14, ethoxylated, sulfates, sodium salts (CAS 68891-38-3) and C12-C14 fatty alcohol polyethylene glycol (2EO) ether suphate, triisopropanolammonium salt (CAS 174450-50-1).

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:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
No positive control.
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:
50%
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
25%
No. of animals per dose:
20 (test group)
10 (control group)
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
25%
No. with + reactions:
0
Total no. in group:
20
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
25%
No. with + reactions:
0
Total no. in group:
20
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
25%
No. with + reactions:
0
Total no. in group:
10
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
25%
No. with + reactions:
0
Total no. in group:
10
Group:
positive control
Remarks on result:
other: no information on positive control group given in study report

No information on positive control group given in study report.

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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
GPMT
Deviations:
yes
Remarks:
No positive control.
GLP compliance:
no
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
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
According to Guideline.
Route:
intradermal and epicutaneous
Vehicle:
water
Concentration / amount:
Intradermal: 0.05%
Epicutaneous: 2.5 %
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
0.1 and 0.5%
No. of animals per dose:
20 (test group)
10 (control group)
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
0.1%
No. with + reactions:
1
Total no. in group:
20
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
0.1%
No. with + reactions:
1
Total no. in group:
20
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0.1%
No. with + reactions:
1
Total no. in group:
10
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0.1%
No. with + reactions:
1
Total no. in group:
10
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
0.5%
No. with + reactions:
6
Total no. in group:
20
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
0.5%
No. with + reactions:
5
Total no. in group:
20
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0.5%
No. with + reactions:
2
Total no. in group:
10
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0.5%
No. with + reactions:
2
Total no. in group:
10
Group:
positive control
Remarks on result:
other: no information on positive control group given in study report

No information on positive control group given in study report.

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:

No data on skin sensitisation are available for AES (C12-14; 1-2.5 EO) C6H15NO3 (CAS 157627-94-6). Therefore, this endpoint is covered by read-across from structurally related AES. The AES reported within the category show similar structural, physico-chemical, environmental and toxicological properties. The approach of grouping different AES for the evaluation of their effects on human health and the environment was also made by the Danish EPA (2001) and HERA (2003), supporting the read-across approach between structurally related AES.

Skin sensitization

There are two studies available addressing skin sensitisation for the analogue substances AES (C12-14; 1-2.5 EO) Na (CAS 68891-38-3) and AES (C12-14; 1-2.5 EO) TIPA (CAS 174450-50-1). Both studies are accounted for in a Weight-of-Evidence approach.

The skin sensitizing potential was assessed with AES (C12-14; 2 EO) Na (CAS 68891-38-3) in a Guinea Pig Maximisation Test according to OECD Guideline 406 (Unger Fabrikker, 1986b). In this study 20 female guinea pigs were induced by intradermal and epicutaneous application of the test item at concentrations of 0.05% (intradermal induction) and 2.5% (epicutaneous induction). Challenge was performed with 0.1 and 0.5%. Water was used as vehicle. At a dose level of 0.1% 1/20 (5%) animals treated with the test item and 1/10 (10%) animals of the control group showed a positive reaction at reading 24 and 48 h after challenge. At the dose level of 0.5% 6/20 animals (30%) after 24 h and 5/20 animals (25%) after 48 h showed a positive response. In the control group 2 of 10 animals (20%) showed a positive response at the 24 and 48 h reading. Thus, the test item showed no significant sensitising potential within this study.

A second study on skin sensitisation was performed with AES (C12-14; 2 EO) TIPA (CAS 174450-50-1) in a Buehler Test on 20 Dunkin-Hartley guinea pigs according to OECD guideline 406 (Sasol, 1997d). The induction was performed with 50% of the test substance and the challenge with 25% of the test substance. Both applications were conducted under occlusive conditions and water was used as vehicle. At both readings (24 and 48 h after challenge) 0/20 animals of the test group and 0/10 animals of the control group showed a positive response. Thus, the test item showed no significant sensitising potential within this study.

 

No sensitising potential of the substance is expected based on the above mentioned data. This is also supported by the evaluation of various AES reported in the HERA report (2003).

Influence of counter ions on sensitizing potential

Since triethanolamine (TEA) in its protonated form (triethanolammonium) is the counter-ion present in Alcohols C12-14, ethoxylated (1-2,5 EO) sulphated, trieth salts (CAS 157627-94-6), TEA might have an impact on the toxicological properties of the registered substance. Therefore, the toxicological profile of TEA is considered. TEA is not listed in Annex VI of Regulation 1272/2008. In addition, the effects of TEA on human health were assessed by the OECD in the SIDS initial assessment Report (2013). Despite of some local signs of irritation TEA gives no rise to concern of adverse effects on human health. Therefore, contribution of TEA to the endpoint sensitization of AES is not expected.

References:

Danish EPA - Environmental and Health Assessment of Substances in Household Detergents and Cosmetic Detergent Products (2001). Environmental Project No. 615, pp. 24-28

HERA (2003). Human & Environmental Risk Assessment on ingredients of European household cleaning products Alcohol Ethoxysulphates, Human Health Risk Assessment Draft, 2003. http: //www. heraproject. com.

SIDS initial assessment report, (2013); http://webnet.oecd.org/HPV/UI/SIDS_Details.aspx?key=8aefe41b-8499-4052-943f-f6dd6f8c5997&idx=0

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 are available for respiratory sensitisation.