2-Hexyldecan-1-ol, ethoxylated

Endpoint summary

Description of key information

Oral (OECD 401), rat: LD50 > 10000 mg/kg bw
Dermal (OECD 402), rabbit and rat: 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:

10 000 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 C16AE (CAS 52609-19-5), studies from similar substances were taken in 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).

Acute oral toxicity

The study addressing acute oral toxicity with the read-across substance C16-18AE (CAS 68439-49-6) was conducted according to OECD Guideline 401 (Sasol, 1986a). In this limit test five Wistar rats per sex received 10,000 mg/kg bw. No mortalities occurred, resulting in a LD50 value of greater than 10,000 mg/kg bw. Clinical signs comprised piloerection only. Moreover, necropsy revealed no effects.

Acute dermal toxicity

No data regarding acute dermal toxicity are available for C16AE (CAS 52609-19-5). Therefore acute dermal toxicity was addressed using structurally related read-across substances in a weight-of-evidence approach, C6-10AE (CAS 112-59-4), C6-12AE (CAS 68439-45-2), C10-16AE (CAS 68002-97-1), C12-13AE (CAS 66455-14-9), C12-15AE (CAS 68131-39-5) and C12-14AE (3EO, CAS 68439-50-9).

The first study with C6-10AE (CAS 112-59-4) equivalent to OECD Guideline 402 was carried out on five New Zealand White rabbits per sex and dose (Ballantyne, 1987). Both sexes were dosed at 900, 1900 and 3700 mg/kg bw under occlusive conditions for 24 h, with the females receiving an additional dose of 2600 mg/kg bw. Mortalities occurred at a dose level of 1900 mg/kg bw and above, resulting in a LD50 of 2000 mg/kg bw for males and 2216 mg/kg bw for females, respectively. Moreover, necropsy revealed dark red or dark pink lungs in the deceased animals.

The second study regarding acute dermal toxicity was conducted with C6-12AE (CAS 68439-45-2). This limit test was conducted equivalent to OECD Guideline 402; however, only four Wistar rats per sex were used (Shell, 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 study conducted with C10-16AE (CAS 68002-97-1) was as well a limit test conducted equivalent to OECD Guideline 402 (Sasol, 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.

With C12-13AE (CAS 66455-14-9), a study according to OECD Guideline 402 was carried out on four Wistar rats per sex and dose (Shell, 1979). Both sexes were dosed at 1000, 2000 and 4000 mg/kg bw under occlusive conditions for 24 h. Mortalities occurred at a dose level of 2000 mg/kg bw and above, resulting in a LD50 of greater than 2000 mg/kg bw and approximately 4000 mg/kg bw. Rats showed at all dose levels hyperactivity to stimuli. In the deceased, additional symptoms like lethargy, dyspnoea and greasy soiled fur and a progressive loss of body weight were observed.

The study conducted with C12-14AE (3EO, CAS 68439-50-9) was performed as limit test conducted similar to OECD Guideline 402 (Huntsman, 1990). In this limit test five New Zealand White rabbits per sex received 3000 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.

In the last study regarding acute dermal toxicity, a limit test with C12-15AE (CAS 68131-39-5) was conducted equivalent to OECD Guideline 402 (Shell, 1978). Four Wistar rats per sex were exposed occlusive to 2000 mg/kg bw 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.

Acute inhalation toxicity

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 five Wistar rats per sex were exposed for a period of 6 h to a vapour of C6-10AE (EO2, CAS 112-59-4) 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 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 (Sasol, 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 Regulation (EC) No. 1272/2008 (CLP) the substance does not need to be classified for acute toxicity.