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Diss Factsheets

Administrative data

Description of key information

No data are available for the target substance sulfuric acid, mono-C12-14 (even numbered)-alkyl esters, ammonium salts (CAS 90583-11-2). Therefore, read-across from structural analogue substances has been applied.


Skin sensitisation (OECD 406, GPMT): not sensitising

Read-across from source substance sulfuric acid, mono-C12-16-alkyl esters, potassium salts (CAS 90583-12-3), supported by additional studies with a structural analogue substances.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Remarks:
Summary of available data used for the endpoint assessment of the target substance.
Adequacy of study:
key study
Justification for type of information:
Refer to the Category Approach Justification document provided in IUCLID6 Section 13
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
1%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Source, key, 90583-12-3, 1988
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
1%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Source, key, 90583-12-3, 1988
Group:
positive control
Remarks on result:
other: no information on positive control in study Source, key, 90583-12-3, 1988
Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.
Conclusions:
In a guinea pig maximisation test (GPMT), no skin sensitisation was observed following occlusive epicutaneous challenge after induction treatments (intracutaneous injection and occlusive epicutaneous exposure).
Executive summary:

The skin sensitisation potential of the target substance is estimated based on an adequate and reliable in vivo study of a structural analogue source substance. In a guinea pig maximisation test (GPMT), no skin sensitisation was observed following occlusive epicutaneous challenge after induction treatments (intracutaneous injection and occlusive epicutaneous exposure). As explained in the category justification, the differences in molecular structure between the target and the source substances are unlikely to lead to differences in the skin sensitisation potential.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

There are no data on skin sensitisation available for the target substance sulfuric acid, mono-C12-14 (even numbered)-alkyl esters, ammonium salts (CAS 90583-11-2). Therefore, this endpoint is covered by read-across from structurally related alkyl sulfates (AS). The possibility of a read-across from 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 physico-chemical, 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, neutralised 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 represents the predominant attribute in mediating effects on mammalian health. Therefore, the members of the AS category have similar physico-chemical, 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 programme carrying out Human and Environmental Risk Assessments (HERA [2]), further supporting the read-across approach between structurally related AS.

Ammonium sulfate is used to produce AS NH4 within the current AS category. There is a substantial data base on ammonium sulfate online available. Ammonium sulfate is not listed in Annex VI of Regulation (EC) No. 1272/2008 (CLP). In addition, the effects of ammonium sulfate on human health were assessed by the OECD in the SIDS initial assessment report [3]. Ammonium sulfate gives no rise to concern of adverse effects on human health. Therefore, a contribution of ammonium sulfate to the effects on human health is considered to be negligible when assessing human health effects of the target substance sulfuric acid, mono-C12-14 (even numbered)-alkyl esters, ammonium salts (CAS 90583-11-2).

Skin sensitisation

Due to the fact that no data for the target substance are available, the results of a key study performed with the structural analogue substance sulfuric acid, mono-C12-16-alkyl esters, potassium salts (CAS 90583-12-3) are used to assess this endpoint. In addition, data obtained with the analogue substances coconut oil, sulfated, ammonium salt (CAS 90989-98-3) and sulfuric acid, palm kernel-oil mono-ester, ammonium salts (CAS 223705-48-4) are used as supportive information.

In a guinea pig maximisation test according to OECD Guideline 406 (BASF, 1988b), which is considered as key study, 20 Pirbright-Hartley guinea pigs were intradermal and epicutaneous induced at 0.1 and 2.5%, respectively, with the test substance sulfuric acid, mono-C12-16-alkyl esters, potassium salts (CAS 90583-12-3, analytical purity 30%). Challenge was performed at a concentration of 1%. The challenge and induction concentrations were based on a preliminary range-finding study. No skin reactions were observed upon challenge. Thus, the test item showed no significant sensitising potential within this study.

The skin sensitizing potential of sulfuric acid, palm kernel-oil mono-ester, ammonium salts (CAS 223705-48-4) was assessed in a Buehler test similar to OECD Guideline 406 (Stepan, 1990). Only limited data on the test item is available. 10 guinea pigs were topically induced 9 times over a period of 3 weeks with 0.1 % test substance and challenged with 0.1% test substance 2 weeks thereafter. 48 h after the first challenge a second challenge was performed with 0.1 % test item. Skin reactions were scored 24 and 48 h after challenge. The challenge and induction concentration was based on a preliminary range-finding study. No skin reactions were observed upon challenge. Thus, the test item showed no significant sensitising potential within this study.

Another supporting study was performed as Buehler test similar to OECD Guideline 406 with coconut oil, sulfated, ammonium salt (CAS 90989-98-3) on 10 guinea pigs. Only limited data on the test item is available (Stepan, 1991). Guinea pigs were topically induced 9 times over a period of 3 weeks with 0.1 % test substance and challenged with 0.1% test substance 2 weeks thereafter. 48 h after the first challenge a second challenge was performed with 0.1 % test item. Skin reactions were scored 24 and 48 h after challenge. The challenge and induction concentration was based on a preliminary range-finding study. No skin reactions were observed upon challenge. Thus, the test item showed no significant sensitising potential within this study.

Results of the above mentioned studies show that all three substances used for read across showed no skin sensitising properties. In addition, the structural related substance sodium lauryl sulfate is also recommended as an agent to induce local irritation in an OECD method to assess skin sensitising properties of chemicals (OECD guideline 406, Guinea Pig Maximisation Test). Therefore, 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

[3] http://webnet.oecd.org/HPV/UI/SIDS_Details.aspx?Key=2c80d506-86bf-4719-be9b-d922022506ec&idx=0

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The available data on skin sensitisation obtainded with structurally analogue substances do not meet the criteria for classification according to the CLP Regulation (EC) No. 1272/2008 and are, therefore, conclusive but not sufficient for classification. Based on read-across the target substance sulfuric acid, mono-C12-14 (even numbered)-alkyl esters, ammonium salts (CAS 90583-11-2) is also not classified for skin sensitisation. No data available for respiratory sensitisation.