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Administrative data

Description of key information

Oral LD50 (OECD Guideline 423), rat >2000 mg/kg bw (limit test)
Dermal LD50 (OECD Guideline 402), rat > 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:
no adverse effect observed
Dose descriptor:
LD50
2 000 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
2 000 mg/kg bw
Quality of whole database:
The whole data base is conclusive and of high quality.

Additional information

No data on acute toxicity are available for AES (C9-11, 1-2.5 EO) NH4 (CAS 160901-27-9). Therefore this endpoint is covered by read-across to structurally related AES, i.e. AES (C8-10, 1-2.5 EO) Na and AES (C9-11, 1-2.5 EO) Na (CAS 160901-28-0) for oral toxicity and AES (C12-14, 1-2.5 EO) Na (CAS 68891-38-3), AES (C12-14, 1-2.5 EO) TIPA (CAS 174450-50-1), AES (C12-13, 3 EO) NH4 and AES (C8-10, 1-2.5 EO) Na for the dermal route. 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.

There are two studies available addressing acute oral toxicity for the read-across substance AES (C8-10, 1-2.5 EO) Na and AES (C9-11, 1-2.5) Na (CAS 160901-28-0).

The study conducted with AES (C8-10, 1-2.5 EO) Na was performed according to OECD Guideline 423 with 6 female Wistar rats in two steps (Leoni, 2012a). Per step, 3 animals received 2000 mg/kg bw test substance via oral gavage. The animals were observed daily for clinical signs of toxicity. Body weight was assessed before treatment and on Days 8 and 15. Upon study termination animals were sacrificed and gross pathology was performed. No mortality occurred. Clinical signs of toxicity within the first 3 days after application comprised among others of piloerection, half eyelid-closure, tremor, reduced spontaneous activity, catalepsis, and kyphosis. No clinical signs were observed thereafter. No effects on body weight and upon necropsy occurred. The LD50 was greater than 2000 mg/kg bw.

The second study regarding acute oral toxicity was conducted on five Sprague-Dawley rats per sex and dose with AES (C9-11) Na (CAS 160901-28-0, Analytical purity 30%, no data on grade of ethoxylation) similar to OECD Guideline 401 (Nicholoson, 1977a). In a preliminary range-finding study, one Sprague-Dawley rat per sex and dose was treated with 1, 50, 500, 5000 and 15,000 mg/kg bw. In the main experiment, both sexes were dosed with the test substance at the limit dose of 5100 mg/kg bw via gavage. During the range-finding study both animals of the top dose group died. In the main study no overt signs of clinical toxicity, no effects on the body weight and also no effects upon gross pathology were observed. However, one female died on day 9. No further mortalities occurred. Hence, the LD50 was determined to be greater than 5100 mg/kg bw for both sexes based on the test material and greater than 1530 mg/kg bw based on the active ingredient.

In the study of Nicholoson (1977a) at the limit dose of 1530 mg/kg bw (based on the active ingredient) 1/10 animals died. However, this was not accompanied by any clinical signs of toxicity and also gross pathology revealed no effects. As this death may be incidental, the LD50 of greater than 2000 mg/kg bw achieved within the key study (Leoni, 2012a) is considered to be appropriate for labelling and classification purposes.

 

Regarding acute dermal toxicity, studies are available for the read-across substances AES (C12-14, 1-2.5 EO) Na (CAS 68891-38-3), AES (C12-14, 1-2.5 EO) TIPA (CAS 174450-50-1), AES (C12-13) NH4 and AES (C8-10, 1-2.5) Na.

The key study with AES (C8-10, 1-2.5) Na was conducted according to OECD Guideline 402 (Leoni, 2012b). The test substance was applied at a dose of 2000 mg/kg bw for 24 h under semi-occlusive conditions. Residual test item was removed thereafter and the animals were observed for clinical signs of toxicity daily. Body weight was assessed before treatment and on Days 8 and 15. Upon study termination animals were sacrificed and gross pathology was performed. Additionally, signs of erythema and oedema were assessed using the scoring system laid down in OECD Guideline 404 (Testing of Acute Dermal Irritation/Corrosion). No mortality and no clinical signs of toxicity occurred. Signs of dermal irritation were observed. Erythema grade 1 was observed on 10/10 animals on day 4 which was fully reversed on day 5 on all animals. Eschar formation was observed from Day 4 to Day 8 and desquamation was observed beginning on Day 6 (10/10 animals both). Desquamation was observed in 7/10 animals until study termination. Scratches were observed in 2 of 5 females. Effects on body weight were seen for females but were considered to be of no toxicological relevance. Also an incidental finding (hernia of the liver) was observed upon gross pathology.

The supporting study conducted with AES (C12-14) Na (CAS 68891-38-3, no data on ethoxylation grade) was performed as limit test conducted according to OECD Guideline 402 with 5 male and 5 female Wistar rats (Hofmann, 1989a-c). The test substance (analytical purity 27%) was applied at 2000 mg/kg bw for 24 h under occlusive conditions. No mortalities and no clinical signs of toxicity occurred. Hence, the LD50 value is greater than 2000 mg/kg bw based on the test material and greater than 540 mg/kg bw based on the active ingredient.

The supporting study conducted with AES (C12-14, 2 EO) TIPA (CAS 174450-50-1, analytical purity: 83.8%) was performed as limit test conducted according to OECD Guideline 402 with 5 male and 5 female Wistar rats (Krueger, 1997). The test substance was applied at 2000 mg/kg bw for 24 h under semi-occlusive conditions. No mortalities and no clinical signs of toxicity occurred. Findings within this study comprised of local irritation at the application site. Hence, the LD50 value is greater than 2000 mg/kg bw based on the test material.

With AES (C12-13, 3EO) NH4, a supporting non-GLP study similar to OECD Guideline 402 was carried out on three male and three female New Zealand White rabbits (Flufs, 1978). Both sexes were dosed at 2000 mg/kg bw (analytical purity 60%) under occlusive conditions for 24 h. No mortalities occurred during the conduct of the study. Findings within this study comprised of local signs of irritation at the application site. The LD50 was greater than 2000 mg/kg bw based on the test material and greater 1200 mg/kg bw based on the active ingredient.

Based on the available data, the LD50 was determined to be greater than 2000 mg/kg bw.

 

No studies for acute inhalation toxicity are available. However, testing the potential of acute toxicity via inhalation route of AES (C9-11, 1-2.5) NH4 (CAS 160901-27-9) is not considered to be 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.

AES is mainly used in liquid media and due to its very low vapour pressure (HERA (2003)) inhalation is not viewed as a significant route of exposure. Inhalation of AES may occur by exposure to aerosols generated by spray cleaners or by inhalation of detergent dusts (e.g. washing powder). Taking into account that the acute toxicity of AES is generally low, no further information on acute toxicity is expected by testing for acute inhalation toxicity.

 

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.


Justification for selection of acute toxicity – oral endpoint
Reliable OECD Guideline study.

Justification for selection of acute toxicity – dermal endpoint
Reliable OECD Guideline study.

Justification for classification or non-classification

According to the classification criteria of Directive 67/548/EEC and Regulation (EC) No 1272/2008 the substance does not need to be classified for acute toxicity.