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Administrative data

Description of key information

Oral LD50 (OECD 423), rat >2000 mg/kg bw (limit test)
Dermal LD50 (OECD 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 (C10-12, 1-2.5 EO) Na (CAS 68610-66-2). Therefore this endpoint is covered by read-across to structurally related AES, i.e.  AES (C8-10, 1-2.5) Na 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 (CAS not yet assigned) for the dermal route. The AES reported within the AES 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.

 

A study addressing acute oral toxicity for the read-across substance  AES (C8-10, 1-2.5 EO) Na is available.

The study conducted with AES (C8-10, -2.5 EO) Na was performed according to OECD Guideline 423 with 6 female Wistar rats in two steps (Z&S, 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 is greater than 2000 mg/kg bw.

 

Regarding the acute dermal toxicity four 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) 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 EO) Na was conducted according to OECD Guideline 402 (Z&S, 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 (Clariant, 1989). 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 (Sasol, 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 signs of 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, 3 EO) NH4, a supporting non-GLP study similar to OECD Guideline 402 was carried out on three male and three female New Zealand White rabbits (P&G, 1978a). 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. Based on the above mentioned findings the LD50 is 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 (C10-12, 1-2.5 EO) Na (CAS 68610-66-2) 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.

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 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 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 classification or non-classification

The available data on acute toxicity do not meet the criteria for classification according to Regulation (EC) No. 1272/2008, and are therefore conclusive but not sufficient for classification.