Registration Dossier

Administrative data

Description of key information

Oral (OECD 401), rat: LD50 = 7560 mg/kg bw
Dermal (OECD 402), rabbit: LD50 > 2000 mg/kg bw
Inhalation (OECD 403), rat, 4 h, (limit test): LC50 > 1600mg/m³ (maximum technically attainable concentration)

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
7 560 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LC50
1 600 mg/m³

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
2 000 mg/kg bw

Additional information

To cover the endpoint acute toxicity of substance C12-13AE (CAS 66455-14-9), studies from similar substances were taken for a weight-of-evidence approach. Read-across is justified because the length of the alkyl chain does not exert any meaningful influence on acute toxicity, whereas the degree of ethoxylation is of more importance. Up to the level of EO = 4, which includes all read-across substances, the toxicity is low (HERA, 2009).

The acute toxicity of alcohol ethoxylates (AEs) has been extensively evaluated in numerous studies with rats and rabbits.

The oral LD50 values, tested with the Cas-No. 112-59-4, 71060-57-6, 68002-97-1, 68439-50-9, 68551-12-2, 66455-14-9, 68131-39-5, 68439-49-6, 68920-66-1, 9005-00-9, 9004-98-2 and 70955-07-6, were all at least above 2 g/kg. The test materials were typically solutions administered orally through gavage. The majority of studies conformed to OECD guidelines and/or EC method and were in compliance with GLP regulation.

The same result was achieved for the dermal route when tested with 112-59-4, 71060-57-6, 68002-97-1, 66455-14-9 and 68131-39-5. An exemplary robust study summary is provided for the oral and the dermal route of exposure. For details on the available data please refer to the category justification.

The acute inhalation studies conducted with 112-59-4 and 68002-97-1 resulted in a LC50 above 1.6 g/m3.

In summary, no classification is warranted for either route of acute toxicity.


Justification for selection of acute toxicity – oral endpoint
Study with the lowest LD50 value was selected.

Justification for selection of acute toxicity – inhalation endpoint
Study with the highest maximum achievable dose was selected.

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

Justification for classification or non-classification

Classifcation criteria according to Regulation (EC) No. 1272/2008 are not fulfilled.