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Administrative data

Description of key information

All available acute oral toxicity studies within this category resulted in acute oral LD50 in rats greater than 2000 mg/kg bw.
Studies on acute oral toxicity were available for the following members of this category (CAS No.):
111-11-5, 111-82-0, 112-39-0, 112-61-8, 91051-34-2, 61788-59-8, 106-70-7, 112-63-0.
The NOAEC for 111-82-0 was found to be > 5 mg/L air.
No acute dermal toxicity studies were available.

Key value for chemical safety assessment

Additional information

Acute oral toxicity:

An acute oral toxicity study was performed with methyl octanoate (CAS No. 111 -11 -5) according to EU Method B.1 (Potokar, 1988). Groups of 5 male and 5 female Wistar rats received doses of 2000 mg methyl octanoate /kg bw in arachis oil by oral gavage.

The animals were observed for 14 days. All animals survived. No signs of systemic toxicity were observed and no abnormalities during gross necropsy were seen. Thus, the acute oral LD 50 in rats was found to be greater than 2000 mg/kg bw.

 

An acute oral toxicity study was performed with methyl laurate (CAS No. 111 -82-0) according to OECD Guideline 401 (Sterzel, 1990). Groups of 5 male and 5 female Wistar rats received doses of 2000 mg methyl laurate /kg bw in arachis oil by oral gavage.

The animals were observed for 14 days. All animals survived. No signs of systemic toxicity occurred. With exception for one female animal with a strong hydrometra no abnormalities were observed during gross necropsy. Thus, the acute oral LD 50 in rats was found to be greater than 2000 mg/kg bw.

 

In another study methyl laurate (CAS No. 111 -82-0) was administered to groups of 5 male and 5 female Sprague-Dawley rats at a dose of 20,000 mg/kg bw by oral gavage (Bjorkquist, 1982). The animals were observed for 14 days. All animals survived. Diarrhoea occurred in 4m/4f and 3m/3f (male/female) animals at days 1 and 2 after dosing. No other clinical signs of systemic toxicity were the observed. In this study the acute oral LD50 in rats was found to be greater than 20 g/kg bw. 

An acute oral toxicity study was performed with methyl palmitate (CAS No. 112-39-0) according to OECD Guideline 401 (Pittermann, 1992). Groups of 5 male and 5 female Wistar rats received doses of 2000 mg methyl palmitate /kg bw in arachis oil by oral gavage. The animals were observed for 14 days. All animals survived. No signs of systemic toxicity were observed and no abnormalities during gross necropsy were seen. The acute oral LD50 for methyl palmitate in rats was found to greater than 2000 mg/kg bw.

 

An acute oral toxicity study was performed with methyl stearate (CAS No. 112-61-8) according to OECD Guideline 401 (Pittermann, 1992). Groups of 5 male and 5 female Wistar rats received doses of 2000 mg methyl stearate /kg bw in arachis oil by oral gavage. The animals were observed for 14 days. All animals survived. No signs of systemic toxicity were observed and no abnormalities during gross necropsy were seen. The acute oral LD50 for methyl stearate in rats was found to greater than 2000 mg/kg bw.

 

An acute oral toxicity study was performed with Fatty acids, palm-oil, Methyl esters (CAS No. 91051-34-2) according to EU Method B.1 (Potokar, 1988).Groups of 5 male and 5 female Wistar rats received doses of 5000 mg Fatty acids, palm-oil, Me esters/kg bw in arachis oil by oral gavage. The animals were observed for 14 days. All animals survived. No signs of systemic toxicity were observed and no abnormalities during gross necropsy were seen. The acute oral LD50 for Fatty acids, palm-oil, Methyl esters in rats was found to greater than 5000 mg/kg bw.

 

An acute oral toxicity study was performed with Fatty acids, coco, Methyl esters (C8 -18, CAS No. 61788 -59 -8) according to EU Method B.1 (Kästner, 1981). Groups of 5 male and 5 female Wistar rats received doses of 5000 mg Fatty acids, coco, Me esters / kg bw in water by oral gavage. The animals were observed for 14 days. All animals survived. During the observation period no signs of systemic toxicity occurred and no abnormalities during gross necropsy except for a slightly reddened gastric mucosa of female animals were seen. Thus, the acute oral LD 50 in rats was found to be greater than 5000 mg/kg bw.

 

An acute oral toxicity study was performed with methyl hexanoate (CAS No. 106-70-7) according to OECD Guideline 401 (Pittermann, 1992).Groups of 5 male and 5 female Wistar rats received doses of 2000 mg methyl hexanoate/kg bw in water by oral gavage. The animals were observed for 14 days. All animals survived. During the observation period no signs of systemic toxicity occurred and no abnormalities during gross necropsy were seen. Thus, the acute oral LD 50 for methyl hexanoate in rats was found to be greater than 2000 mg/kg bw.

 

An acute oral toxicity study was performed with Fatty acids, C14-18 and C16-18-unsatd., Methyl esters (CAS No. 67762-26-9) according to EU Method B.1 (Potokar, 1988).Groups of 5 male and 5 female Wistar rats received doses of 2000 mg /kg bw in arachis oil by oral gavage. The animals were observed for 14 days. All animals survived. During the observation period no signs of systemic toxicity occurred and no abnormalities during gross necropsy were seen. Thus, the acute oral LD 50 for Fatty acids, C14-18 and C16-18-unsatd., Methyl esters in male and female Wistar rats was found to be greater than 2000 mg/kg bw.

 

An acute oral toxicity study was performed with methyl linoleate (CAS No. 112-63-0) according to OECD Guideline 401 (Pittermann, 1992).Groups of 5 male and 5 female Wistar rats received doses of 2000 mg methyl linoleate/kg bw in arachis oil by oral gavage. The animals were observed for 14 days. All animals survived. During the observation period no signs of systemic toxicity occurred and no abnormalities during gross necropsy were seen. Thus, the acute oral LD 50 for methyl linoleate in male and female rats was found to be greater than 2000 mg/kg bw.

Acute inhalation toxicity:

An acute inhalation toxicity study was performed with methyl laurate (CAS No. 111 -82 -0) according to OECD guideline 436 (Huygevoort, 2010). Three Crl:WI (Han) rats per sex were exposed (head/nose only) to an aerosol of the test material with an actual concentration of 5.6 ± 0.5 mg/L air (nominal concentration was 7.1 mg/L) for a exposure duration of four hours. No mortality occurred. Lethargy, hunched posture and/or laboured respiration were noted among all animals at 1 hour after exposure, with hunched posture persisting until Day 2 after exposure. No clinical signs were noted during exposure. Body weight gain in males and females were within the range expected for rats of this strain and age used in this type of study. No abnormalities were found at macroscopic post mortem examination of the animals. Thus, the LC 50 after acute inhalation of methyl linoleate in male and female rats was found to be greater than 5.6 mg/l air.

 

Justification for classification or non-classification

According to DSD and CLP classification criteria for acute oral toxicity, no classification is required for any of the members of the Category SCAE Methylester.

According to DSD and CLP classification criteria for acute inhalation toxicity, no classification is required.