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EC number: 500-464-9
CAS number: 160901-27-9
1 - 2.5 moles ethoxylated
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.
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
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
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.
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.
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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