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Description of key information

Oral LD50 (OECD guideline 401), rat = 1650 mg/kg bw
Dermal LD50 (OECD guideline 402), rabbit >= 2000 mg/kg bw (limit test)
Acute toxicity by inhalation was not tested according to REGULATION (EC) No 1907/2006, Annex VIII, Section 8.5, Column 2.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
1 650 mg/kg bw
Quality of whole database:
The whole data base is conclusive and of high quality.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available
Quality of whole database:
Acute toxicity by inhalation was not tested according to REGULATION (EC) No 1907/2006, Annex VIII, Section 8.5, Column 2.

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
The whole data base is conclusive and of high quality.

Additional information

There is no study regarding the acute toxicity of C8-14AS TEA&NH4 (CAS 96690-74-3) available. Therefore this endpoint is covered by read-across to structurally related alkyl sulfates, i.e. C8-14AS TEA (CAS 85665-45-8) and C8-14AS NH4 (CAS 90583-10-1) for acute oral toxicity and C10-16AS NH4 (CAS 68081-96-9), C10-16AS Mg (CAS 68081-97-0), C12-13AS K (CAS 91783-22-1) and C8AS Na (CAS 142-31-4) for the dermal route.

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.

There is 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 C8-14AS TEA&NH4 (CAS 96690-74-3). 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 directive 1272/2008. In addition the effects of ammonium sulfate on human health were assessed by the OECD in the SIDS initial assessment Report [4]. 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 C8-14AS TEA&NH4 (CAS 96690-74-3).

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]).

acute oral toxicity

The endpoint acute oral toxicity is covered via a weight-of-evidence approach.

In the study of Gloxhuber (1972), 5000 mg/kg bw C8-14AS NH4 (CAS 90583-10-1, analytical purity 33%) was applied via gavage to 10 male Wistar rats. One of ten animals died within the 8 days observation period. Thus the LD50 was >5000 mg/kg bw based on the test substance and > 1650 mg/kg bw based on the active ingredient. As only limited information on methodology and results were available a study with an alkyl sulphate having an comparable carbon chain length distribution, i.e. C8-14AS TEA was considered.

The study conducted with C8-14AS TEA (CAS 85665-45-8, analytical purity 46-49%) was performed on Wistar rats. The test substance was applied via gavage to 10 rats. Only limited information concerning test conditions and the experimental method is available. The observation period lasted 8 days and clinical signs of toxicity comprised of abdominal position, decreased motility and apathy. No findings were observed upon necropsy. The LD50 was reported as >7.94 mL/kg bw based on the test substance and is thus > 3625 mg/kg bw based on the active ingredient.

Taken together the results achieved with C8-14AS NH4 (CAS 90583-10-1) represent a worst case scenario and therefore the LD50 was set to 1650 mg/kg bw.

acute dermal toxicity

Regarding the acute dermal toxicity four studies are available for the read-across substances C10-16AS NH4 (CAS 68081-96-9), C10-16AS Mg (CAS 68081-97-0), C12-13AS K (CAS 91783-22-1) and C8AS Na (CAS 142-31-4).

The key study was conducted with C8AS Na (CAS 142-31-4) according to OECD Guideline 402. 5 Wistar rats per sex were treated with 2000 mg/kg bw under semi occlusive conditions for 24 h (BASF, 2012). No mortality occurred, no sign of systemic toxicity and of local irritation was observed.

The study conducted with C10-16AS NH4 (CAS 68081-96-9) was performed as limit test conducted similar to OECD Guideline 402 with 3 male and 3 female New Zealand White rabbits (Frank, 1975). The test substance (analytical purity 25.1%) was applied at 2000 mg/kg bw for 24 h under occlusive conditions. No mortalities occurred. Clinical signs of toxicity comprised of severe erythema and slight eschar formation at 24 h, necrosis by day 2–14 with sloughing of the skin by day 8–14 and hyper-pigmentation of new skin by day 14. No signs of systemic toxicity were observed. Hence, the LD50 value is greater than 2000 mg/kg bw based on the test material and greater than 500 mg/kg bw based on the active ingredient.

The study conducted with C10-16AS Mg (CAS 68081-97-0) was performed as limit test conducted using a method similar to OECD Guideline 402 with 3 male and 3 female New Zealand White rabbits (Frank, 1975). The test substance (analytical purity 23.5%) was applied at 2000 mg/kg bw for 24 h under occlusive conditions. No mortalities occurred. Clinical signs of toxicity comprised of severe erythema and eschar formation at 24 h, necrosis by Day 5–21 and necrotic tissues sloughed and leaving skin hyper-pigmented at Day 21. Thus, the LD50 value is greater than 2000 mg/kg bw based on the test material and greater 500 mg/kg bw based on the active ingredient.

Another study similar to OECD Guideline 402 was performed with C12-13AS K (CAS 91783-22-1) on three male and three female New Zealand White rabbits (Benedict, 1978). Both sexes were dosed at 2000 mg/kg bw (analytical purity 25%) under occlusive conditions for 24 h. No mortalities occurred during the study. Findings consist in moderate to severe erythema, edema, and atonia, desquamation and fissuring by day 6 and eschar formation and exfoliation. Based on the above mentioned findings the LD50 is greater than 2000 mg/kg bw based on the test material and greater 500 mg/kg bw based on the active ingredient.

Within the studies mentioned above no mortalities or signs of systemic toxicity occurred after dermal application of alkyl sulfates with varying carbon chain length. Taken into account the generally low toxicity after oral application and the low dermal absorption rate of alkyl sulfates (approx. 1%) this result was expected. In agreement, no classification for acute dermal toxicity is required. For details on absorption please see section Toxicokinetucs, metabolim and distribution.

acute inhalation toxicity

No studies for acute inhalation toxicity are available. However, testing the potential of acute toxicity via inhalation route ofC8-14AS TEA&NH4 (CAS 96690-74-3) is considered to be not justified. According to Regulation (EC) No 1907/2006, Annex VIII, Section 8.5, Column 2, in addition to the oral route (8.5.1), for substances other than gases, the information mentioned under 8.5.2 to 8.5.3 shall be provided for at least one other route. As information under 8.5.3 (dermal route) is provided, the requirement is fulfilled by using the most appropriate route of exposure.

AS is mainly used in liquid media and due to its very low vapour pressure [2] 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). Taken into account that the acute toxicity of AS is generally low no further information on acute toxicity is expected by testing for acute inhalation toxicity as the predominant effect will comprise of local irritant effects rather than systemic toxicity. However, as the neat substance has to be classified as harmful if swallowed the substance will also be classified as harmful if inhaled (H332: Acute tox 4 and R20, respectively) in case the substance is available as neat powder.

REFERENCES:

[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

[4] Referenz available at:

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


Justification for selection of acute toxicity – oral endpoint
The study was selected as the LD50 achieved within this study is used for classification purposes.

Justification for selection of acute toxicity – dermal endpoint
The key study with pure test item at the limit dose was selected.

Justification for classification or non-classification

The available data on acute oral toxicity meet the criteria for classification as Acute Toxic Category 4 (H302) according to Regulation (EC) 1272/2008 and as Xn (R22) according to Directive 67/548/EEC.

The available data on acute dermal toxicity do not meet the criteria for classification according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification.