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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

There is one study available addressing the acute oral toxicity of AES (C8-10, 1-2.5 EO) Na .

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 is greater than 2000 mg/kg bw.

There is one study available addressing the acute dermal toxicity of 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 (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.

No studies for acute inhalation toxicity are available. However, testing the potential of acute toxicity via inhalation route of AES (C8-10, 1-2.5 EO) Na 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 [1] 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.

 

 [1] (HERA report, 2003),
http://www.heraproject.com/files/1-HH-04-HERA%20AES%20HH%20web%20wd.pdf


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.