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Administrative data

Description of key information

Oral LD50 (OECD guideline 401), rat = 2870 mg/kg bw
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:
adverse effect observed
Dose descriptor:
LD50
Value:
2 870 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

No data on acute toxicity are available for AES (C12-14, 1-2.5 EO) NH4 (CAS 125301-88-4). Therefore this endpoint is covered by read across to structurally related AES, i.e. AES (C12-14, 1-2.5 EO) Na (CAS 68891-38-3) and AES (C10-16) NH4 (CAS 67762-19-0) for oral toxicity. For dermal toxicity read across to AES (C12-14, 1-2.5 EO) Na (CAS 68891-38-3) and additionally AES (C12-13, 3 EO) NH4 (CAS 68585-34-2), AES (C12-14, 1-2.5 EO)Na (CAS 68891-38-3) and AES (C8-10, 1-2.5 EO) Na was performed. 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.

There are two studies available addressing acute oral toxicity for the read-across substances AES (C12-14, 1-2.5 EO) Na (CAS 68891-38-3) and AES (C10-16) NH4 (CAS 67762-19-0).

The study conducted with AES (C12-14, 2 EO) Na (CAS 68891-38-3) was performed according to OECD Guideline 401 with acceptable restrictions on five Sprague-Dawley rats per sex and dose (Kynoch, 1986). Both sexes were dosed with the test substance (analytical purity 70%) at 2000, 3200, 4000 and 5000 mg/kg bw via gavage. Mortalities occurred at the highest dose levels of 4000 and 5000 mg/kg, resulting in a LD50 of 4100 mg/kg bw for males and females based on the test material. Based on the active ingredient the LD50 is 2870 mg/kg bw for males and females. Upon gross pathology no effects were observed.

The results of this study are supported by the results of the weight of evidence study performed with AES C10-16 NH4 (CAS 67762-19-0, analytical purity 23.4%, no data on degree of ethoxylation). The study was conducted on male mice similar to OECD Guideline 401 (Potokar, 1972). As only basic data of this study are available reliability of the study could not be assessed (RL4). The LD50 in male mice was greater than 10,000 mg/kg bw based on the test material and greater than 2340 mg/kg bw based on the active ingredient.

 

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 EO) TIPA (CAS 174450-50-1), AES (C12-13) NH4 and AES (C8-10; 1-2.5 EO) Na.

The key study with AES (C8-10; 1-2.5 EO) Na was conducted according to OECD Guideline 402 as a limit test at 2000 mg/kg bw on 5 Wistar rats per sex (Leoni, 2012). The pure test substance was applied for 24 h under semi occlusive conditions. No mortalities and no clinical signs of toxicity occurred. Hence, the LD50 value is greater than 2000 mg/kg bw. 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. Upon gross pathology hernia (liver) into the diaphragm was observed in one female. This incidental finding is not considered to be treatment related. A further incidental finding was a decreased body weight of 3/5 females after one week. As the females gained weight thereafter and no effect on body weight was observed for males this finding is of no toxicological relevance.

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, 1997a). 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) 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. Based on the above mentioned findings the LD50 is greater than 2000 mg/kg bw based on the test material and greater than 1200 mg/kg bw based on the active ingredient.

No mortalities occurred within the above mentioned studies independent of the chain length and the counter ion of the AES. Hence, the LD50 is 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 C12-14AES 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.

None of the above mentioned data suggested AES to be harmful to health upon acute exposure, independent of the chain length of the AES.

 

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.