Castor oil, hydrogenated

Endpoint summary

Description of key information

All available acute toxicity studies within this Category showed that Fatty Acid Glycerides are non-toxic via the oral, dermal or inhalation exposure route. 
Studies on acute oral toxicity were available for the following members of this category (CAS No.): 
31566-31-1, 67701-26-2, 67701-33-1, 73398-61-5, 8001-78-3, 85251-77-0, 91744-13-7 and medium and long chain triglycerols (Matulka, 2006). 
The acute oral LD50 for rats and mice in all studies was found to be greater than 2000 or 5000 mg/kg bw.
Studies on acute dermal toxicity were available for the following members of this category (CAS No.): 
91845-19-1, 620-67-7, 555-43-1.
The acute dermal LD50 in rats in all studies was found to be greater than 2000 mg/kg bw
One study on acute inhalation toxicity was available for the following member of this category (CAS No.): 73398-61-5.
No signs of systemic toxicity occured in male rats upon acute inhalation exposure to the maximum attainable concentration of Triglycerides, mixed decanoyl and octanoyl (CAS No.: 73398-61-5).

Additional information

Acute oral toxicity:

All available acute oral toxicity studies confirmed that Fatty Acid Glycerides are non-toxic.

In an acute oral toxicity study (limit test) in Wistar rats the acute oral LD50 for medium and long chain triglycerides was found to be greater than 5000 mg/kg bw (Matulka, 2006).

In an acute oral toxicity study (limit test) in female NMRI mice the acute oral LD50 for stearic acid, monoester with glycerol (CAS No. 31566 -31 -1) was found to be greater than 5000 mg/kg bw (Dufour, 1993).

In an acute oral toxicity study (limit test) in Sprague-Dawley rats the acute oral LD50 for C12-C18 trialkyl glyceride (CAS No. 67701 -26 -2) was found to be greater than 2000 mg/kg bw (Jones, 1988).

In an acute oral toxicity study (limit test) in NMRI mice the acute oral LD50 for Glycerides, C14-18 mono- and di- (CAS No. 67701-33-1) was found to be greater than 2000 mg/kg bw (Gomond, 2000).

In an acute oral toxicity study (limit test) in Wistar rats the acute oral LD50 for Castor oil, hydrogenated (CAS No. 8001 -78 -3) was found to be greater than 20000 mg/kg bw (Gloxhuber, 1969).

In an acute oral toxicity study (limit test) in rats the acute oral LD50 for Glycerides, C16-18 mono- and di- (CAS No. 85251-77-0) was found to be greater than 2000 mg/kg bw (Ruat, 1999).

In an acute oral toxicity study (limit test) in Wistar rats the acute oral LD50 for Glyceride, C14-18 and C16-22 unsaturated, mono- and di- (CAS No. 91744-13-7) was found to be greater than 2000 mg/kg bw (Sterzel, 1990).

 

Acute inhalation toxicity:

In an acute inhalation study (Reminghaus, 1976) male rats were exposed for 6 hours to approx. 1.86 mg/L aerosol (analytical concentration, maximum attainable concentration) of mixed decanoyl and octanoyl glycerides (CAS No. 73398 -61 -5). No mortality occurred and no signs of systemic toxicity were observed.

 

Acute dermal toxicity:

All available acute dermal toxicity studies confirmed that Fatty Acid Glycerides are non-toxic.

In an acute dermal toxicity study (limit test) in Wistar rats the acute dermal LD50 for Glycerides, C16-18 and C18-hydroxy mono- and di- (CAS No. 91845-19-1) was found to be greater than 2000 mg/kg bw (Potokar, 1985).

In an acute dermal toxicity study (limit test) in Wistar rats the acute dermal LD50 for Glycerol Tristearate (CAS No. 555 -43 -1) was found to be greater than 2000 mg/kg bw (Krueger, 1998).

In an acute dermal toxicity study (limit test) in rats the acute dermal LD50 for propane-1,2,3-triyl trisheptanoate (CAS No. 620-67-7) was found to be greater than 2000 mg/kg bw (Mürmann, 1993).

 

Justification for classification or non-classification

Members of the Category fatty acid glycerides are liquid or solid substances. For liquid fatty acid glycerides with a vapour pressure at room temperature < 0.01 Pa exposure to vapour can be excluded. For waxy solid fatty acid glycerides inhalation exposure seems very unlikely. Fatty acid glycerides with melting temperatures below 55ºC are commonly presented in pellet, flake, block or paste form. Fatty acid glycerides with melting temperatures above 55ºC may be turned into powder using conventional spray-cooling technology. The particle size of powdered fatty acid glycerides is not a function of chemical composition, but is determined by the spray-cooling conditions. For the majority of industrial applications powders with mean particle size (D(0.5)) above 150µm are preferred. Powders with mean particle size (D(0.5)) down to 40µm can be produced for special applications (mainly for use as food additives). For standard and coarse powders with mean particle size above 150µm the proportion of respirable dust (powder with particle size below 10µm is negligible. For fine powders the proportion of respirable dust is below 5.5% and is not considered to be significant. Fatty acid glycerides are not corrosive and are readily hydrolysed in the body by ubiquitously expressed lipases and esterases. The likelihood of persistence in the lungs is considered to be negligible. Thus, it was judged to be justified to use the category member Glycerides, mixed decanoyl and octanoyl (CAS No. 73398-61-5) being a liquid substance as Read Across substance for the whole category, as it was assumed that in case of respiratory exposure to fatty acid glycerides the toxicological behaviour would be similar for all category members.

According to DSD (67/548/EEC) or CLP (1272/2008/EC) classification criteria for acute toxicity, no classification is required.