Registration Dossier

Administrative data

Description of key information

skin irritation (OECD 404): irritating
eye irritation (OECD 405): highly irritating/corrosive
SCLs according to GHS:
>=10% - <20% Eye Irrit. Cat.2, R36
<10% No Classification

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

There is one relevant study available for the endpoints skin and eye irritation with C12-14AS TEA (CAS 90583-18-9). Additionally a read across to structurally related AS, i.e. C12AS Na (CAS 151-21-3) for skin irritation and C10-16AS Na (CAS 68585-47-7) and C12-13AS K (CAS 91783-22-1) for eye irritation was performed.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 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.

The contribution of TEA to the endpoint irritation was already evaluated in the HERA report [2]. There it was given that TEA salts are less irritating than the sodium salts. Furthermore local effects of the fore stomach observed after repeated treatment via gavage were partially reversible for C12AS Na and fully reversible for C12-14 AS TEA. Therefore the read-across to sodium alkyl sulfates is expected to be valid.

There is further a substantial data base on triethanolamine (TEA) online available. TEA is not listed in Annex VI of directive 1272/2008. In addition the effects of TEA on human health were assessed by the OECD in the SIDS initial assessment Report [3]. Despite of some local signs of irritation TEA gives no rise to concern of adverse effects on human health. Therefore a contribution of TEA to the effects on human health is considered to be negligible when assessing human health effects of C12-14AS TEA (CAS 90583-18-9). Therefore, read across to alkyl sulfates with other counter ions is considered to be valid and reliable. This approach was also followed by the OECD in the SIDS initial assessment profile [1] and by the voluntary industry programme carrying out Human and Environmental Risk Assessments (HERA [2]).

Skin irritation

There is one relevant study for C12-14AS TEA (CAS 90583-18-9) and one relevant study for the read-across substance C12AS Na (CAS 151-21-3) addressing skin irritation.

The key study conducted with C12-14AS TEA (CAS 90583-18-9, analytical purity 41-42%) was performed according to OECD Guideline 404 under occlusive conditions (Kästner, 1987). Each of 5 rabbits (strain: Kleinrusse Chbb:HM) was exposed to 0.5 mL of the test item (25 % based on active ingredient, no data on vehicle) for 4 h under occlusive conditions. Animals were examined for skin reactions 1, 24, 48 and 72 h as well as on days 7, 10, 14, 17, and 21. The mean erythema and edema score after 24 and 72 h were 3.7 and 2.1, respectively. Both were fully reversible within 14 days. Thus, C12-14AS TEA (CAS 90583-18-9) was irritating at a concentration of 25% in this study.

A supporting study was conducted with C12AS Na (CAS 151-21-3, analytical purity 100%) similar to OECD Guideline 404 under occlusive conditions (Esposito, 1976). Each of 6 New Zealand White rabbits was exposed for 24 h to 0.5 mL of the unchanged test item and observed for a period of 72 h for erythema and edema. No scoring was done 48 h after application. The mean erythema and edema score after 24 and 72 h were 2.2 and 1.7, respectively. Both were not reversible within 72 h. When using the higher value of the 24 and 72 h time points as 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 1272/2008/EC and R38 according to Directive 67/548/EEC. 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 and R37, respectively) in case the substance is available as neat powder.

Eye irritation

There is one relevant study for C12-14AS TEA (CAS 90583-18-9) addressing eye irritation.

In an OECD guideline 405 study (Kästner, 1987) 0.1 mL of C12-14AS TEA (CAS 90583-18-9, analytical purity 41-42%) was applied to one eye of each of four rabbits (strain: Kleinrusse Chbb:HM) at a concentration of 25% based on active ingredient. Eye reactions were scored 1, 6, 24, 48 and 72 h and 7, 10, 14, 17 and 21 days after application. The mean (24, 48 and 72 h reading) cornea, iris, conjunctivae and chemosis scores were 1, 0, 2.8 and 0.7. Chemosis was fully reversible within 7 days. Effects on the cornea were fully reversible in 3/4 animals within 10 days. However corneal opacity was still observed in 1 animal after 21 days (score: 1). The conjunctival redness was fully reversible in 3/4 animals within 14 days. However corneal opacity was still observed in 1 animal after 21 days (score: 1). Thus, a concentration of 25% of C12-14AS TEA (CAS 90583-18-9) is borderline between classification as severe damage to the eye and irritating to the eye. As the other members of the AS category are classified as R41 above concentrations of 20%. this is also applied to C12-14AS TEA (CAS 90583-18-9).

As corrosion and irritation depends on the concentration of the substance in a solvent, further studies with lower concentrations of the test substances were also considered to assess whether specific concentration limits can be set. For this purpose, one study with C12-13AS K (CAS 91783-22-1) and two studies with C10-16AS Na (CAS 68585-47-7) with a concentration range of 10 to 22% were evaluated.

 

In the study with C12-13AS 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 an 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 indicated signs of irritation after 21 days. However, irritation showed a clear tendency to decrease with time. No reading on day 28 was possible due to death of the rabbit. 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 C10-16AS Na (CAS 68585-47-7, analytical purity 10%) was performed similar to OECD Guideline 405 (Kukulinski, 1980a) on 3 New Zealand White rabbits with an observation period of 7 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 C10-16AS Na (CAS 68585-47-7, analytical purity 10%)was performed similar to OECD Guideline 405(Kukulinski, 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%.

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%.

 

[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] SIDS initial assessment report, (1995);

http://webnet.oecd.org/HPV/UI/SIDS_Details.aspx?Key=5ca67317-5fcc-41ea-a429-53d1267be383&idx=0


Justification for selection of skin irritation / corrosion endpoint:
Reliable OECD guideline study.

Justification for selection of eye irritation endpoint:
Reliable OECD guideline study.

Effects on skin irritation/corrosion: irritating

Effects on eye irritation: corrosive

Justification for classification or non-classification

According to the classification criteria of Directive 67/548/EEC and Regulation (EC) No 1272/2008 the test substance needs to be classified with Xi, R38/R41 and Skin Irrit. 2, H315 and Eye Dam.1, H318, respectively.

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 and according to Directive 67/548/EEC only the classification R36 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).