Alcohols, C16-18 and C18-unsatd., propoxylated

Endpoint summary

Description of key information

Oral (OECD 401), rat: LD50 > 2000 mg/kg bw
Dermal (OECD 402), rabbit: LD50 > 2000 mg/kg bw
Inhalation (OECD 403), rat, 4 h, (limit test): LC50 > 1.6mg/L (maximum technically attainable concentration)

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

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

Additional information

No data for Alcohols, C16-18 (even numbered) and C18 unsaturated, propoxylated, < 2.5 PO (CAS 70955-07-6) are available. Therefore this endpoint is covered via read-across from structurally related substances, i.e. alcohols propoxylated (C12-14, 5 PO, CAS 68439-59-5), alcohols propoxylated (C12-14, 10 PO), C16-18 and C18-unsatd. AE (2.5 EO, CAS 68920-66-1) and alcohol propoxylates (C18, 15 PO, CAS 25231-21-4) for acute oral toxicity; C6-10AE (2EO, CAS 112-59-4) and C10-16AE (2 EO, CAS 68002-97-1) for acute inhalation toxicity and C6-10AE (2 EO, CAS 112-59-4), C6-12AE (2.5 EO, CAS 68439-45-2), C10-16AE (2 EO, CAS 68002-97-1), C12-13AE (2 EO, CAS 66455-14-9), C12-15AE (3 EO, CAS 68131-39-5) and alcohol propoxylates (C18, 15 PO, CAS 25231-21-4) for acute dermal toxicity.

Acute oral toxicity

A study for acute oral toxicity with alcohols propoxylated (C12-14, 5 PO, CAS 68439-59-5) was performed in rats similar to OECD guideline 401 (Potokar, 1982a). A group of 10 Wistar TNO rats (5 males and 5 females) was treated with the limit dose of 2000 mg/kg bw of the test substance by gavage. The observation period following administration was 14 days. During the study period, no mortality and no clinical signs of toxicity were observed in any animal. All test animals showed normal body weight gain. Therefore, the oral LD50 in male and female rats was greater than 2000 mg/kg bw.

In a second oral acute toxicity study with alcohols propoxylated (C12-14, 10 PO) 10 male CF1 mice were dosed with the limit dose of 5000 mg/kg bw of the test substance by gavage (Potokar, 1976). The observation period following administration was 8 days. During the study period, no mortality was observed in any animal. However, light symptoms of intoxication were observed after the 8 day observation period.

In an oral acute toxicity study with C16-18 and C18-unsatd. AE (2.5 EO, CAS 68920-66-1) 5 male and 5 female Wistar rats were dosed with the limit dose of 2000 mg/kg bw of the test substance by gavage (Potokar, 1982 b). No mortality an no clinical signs of toxicity were observed in any animal.

In a further shortly reported acute oral toxicity study with alcohol propoxylates (C18, 15 PO, CAS 25231-21-4) 5 male and female rats were orally administered with the test item. The observation period comprised 14 days. The LD 50 was calculated to be LD50 6310 mg/kg bw day. 

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 to C6-10AE (2EO, CAS 112-59-4) 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 (2 EO, 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.

Acute dermal toxicity

No data regarding acute dermal toxicity are available for Alcohols, C16-18 (even numbered) and C18 unsaturated, propoxylated, < 2.5 PO (CAS 70955-07-6). Therefore acute dermal toxicity was addressed using structurally related read-across substances for a weight-of-evidence approach, i.e. C6-10AE (CAS 112-59-4), C6-12AE (CAS 68439-45-2), C10-16AE (CAS 68002-97-1), C12-13AE (CAS 66455-14-9) and C12-15AE (CAS 68131-39-5).

The first study with C6-10AE (2 EO, CAS 112-59-4, Ballantyne, 1987) equivalent to OECD Guideline 402 was carried out on five New Zealand White rabbits per sex and dose. 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 on acute dermal toxicity was conducted with C6-12AE (2.5 EO, CAS 68439-45-2). This limit test was conducted equivalent to OECD Guideline 402 (Cassidy, 1979). However, only four Wistar rats per sex were used. 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 (2 EO, 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.

A study according to OECD Guideline 402 was carried out with C12-13AE (2 EO, CAS 66455-14-9), on four Wistar rats per sex and dose (Cassidy, 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.

A limit test with C12-15AE (3 EO, CAS 68131-39-5) was conducted equivalent to OECD Guideline 402 (Cassidy, 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.

In an acute dermal toxicity study, 5000 mg/kg bw of the test substance alcohol propoxylates (C18, 15 PO, CAS 25231-21-4) was applied to the clipped skin of 6 male and female New Zealand Albino rabbits under occlusive conditions for 24 h (Yanagimoto, 1984). The test sites of 3 males and 3 females were abraded. Skin reactions were scored according to Draize, J.H. et al. (1944). After removal of the patch the skin was washed. The observation period was 14 days. No mortality was observed during the study period. A very slight erythema was observed in most animals after the exposure period. Under the condition of the study the substance was classified as mild irritant according to the Draize score criteria. However the data are not sufficient to draw a conclusion about the skin irritation potential of the test item. The LD50 was determined to be greater than 5000 mg/kg bw.

Justification for selection of acute toxicity – oral endpoint
No study selected as a weight of evidence approach is followed.

Justification for selection of acute toxicity – inhalation endpoint
Study selected of which the LC50 was derived.

Justification for selection of acute toxicity – dermal endpoint
No study selected as a weight of evidence approach is followed.

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.