Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Oral (OECD 401), rat: LD50 > 5050 mg/kg bw
Dermal (OECD 402), rat and 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
Value:
5 050 mg/kg bw

Acute toxicity: via inhalation route

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

Acute toxicity: via dermal route

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

Additional information

To cover the endpoint acute toxicity of substance C10-12AE (CAS 67254-71-1), studies from similar substances were taken for a read-across or 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 study addressing acute oral toxicity study with C10-16AE (CAS 68002-97-1) was conducted according to OECD Guideline 401 (Kuhn, 1992). In this limit test five Sprague-Dawley rats per sex received 5050 mg/kg bw. No mortalities occurred, resulting in a LD50 value of greater than 5050 mg/kg bw. Clinical signs comprised activity decrease, diarrhoea, piloerection and polyuria. Moreover, necropsy revealed no effects.

For addressing acute dermal toxicity, the first acute dermal toxicity was conducted with C6-12AE (CAS 68439-45-2). This limit test was conducted equivalent to OECD Guideline 402 since only four Wistar rats per sex were used (Cassidy, 1979) . The dose level of 2000 mg/kg bw was applied occlusive for 24 h and caused neither treatment-related clinical signs nor mortalities. Hence, the LD50 was determined to be greater than 2000 mg/kg bw.

The second acute dermal toxicity study with C10-16AE (CAS 68002-97-1) was as well a limit test conducted equivalent to OECD Guideline 402 (Thompson, 1982). In this limit test five New Zealand White rabbits per sex received 2000 mg/kg bw for a 24 h-occluded exposure. No mortalities occurred, hence, the LD50 value was set to greater than 2000 mg/kg bw.

There are two studies available addressing acute inhalation toxicity, being performed with C6-10AE (CAS 112-59-4) and C10-16AE (CAS 68002-97-1) and equivalent to OECD Guideline 403.

In the first study with C6-10AE (CAS 112-59-4) five Wistar rats per sex were exposed for a period of 6 h to a vapour of the test substance at the calculated saturated vapour concentration of 100 mg/m³ (Ballantyne, 1987). No mortality or clinical signs occurred during the exposure period. The LC50 was determined to be greater than 100 mg/m³ for exposure to an aerosol of the test substance for 6 h.

In the second study with C10-16AE (CAS 68002-97-1) five Sprague Dawley rats/sex were exposed for a period of 4 h to an aerosol of the test substance at a concentration of 1600 mg/m³ (corresponding to 1.6 mg/L), which is the maximum technically attainable concentration of the test substance with a MMAD < 4 µm (limit test, Coate, 1982). No mortality occurred during the exposure or the 14-day observation period. The animals demonstrated clinical signs of toxicity like slight nasal discharge and lacrimation during exposure as well as slight, red nasal discharge post-exposure. The LC50 was determined to be greater than 1600 mg/m³ for exposure to an aerosol of the test substance for 4 h.


Justification for selection of acute toxicity – oral endpoint
Reliable Guideline study chosen.

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
No study chosen due to woe approach

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.