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Description of key information

All available acute oral toxicity studies within this category resulted in an acute oral LD50 > 2000 mg/kg bw. 
Studies on acute oral toxicity were available for the following members of this category (CAS#):
10233-13-3, 110-27-0, 142-91-6, 112-11-8, 544-35-4, 26399-02-0, 135800-37-2, 91031-48-0, 29806-73-3, 123-95-5, 163961-32-8.
All available acute dermal toxicity studies within the category resulted in acute dermal LD50 > 2000 mg/kg bw.
Studies on acute dermal toxicity were available for the following members of this category (CAS#): 544-35-4, 163961-32-8
Studies on acute inhalation toxicity were available for the following members of this category (CAS#): 10233-13-3, 26399-02-0, 135800-37-2, 67762-63-4

Key value for chemical safety assessment

Additional information

All available experimental data on acute oral, inhalation and dermal toxicity indicate that the members of this category are practically non-toxic:

 

Acute oral toxicity - Ethyl esters

An acute oral toxicity study with ethyl linoleate (CAS# 544-35-4) was performed according to OECD Guideline 423 (acute toxic class method, limit test) (van Otterdijk, 2010). Ethyl linoleate was administered by oral gavage to two subsequent groups of three female Wistar rats at 2000 mg/kg body weight. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice (Day 15). No treatment related abnormalities were observed. The oral LD50 value in female rats was found to exceed 2000 mg/kg bw.

 

Acute oral toxicity - isopropyl esters

An acute oral toxicity study (limit test) was performed with isopropyl laurate (CAS# 10233 -13 -3) similar to OECD Guideline 401 (Dufour, 1991). 5 female NMRI EOPS mice received single oral doses of 5000 mg/kg bw. The animals were observed for 6 days after administration. No mortalities occurred. No signs of clinical toxicity were reported. All animals showed the expected gain in bodyweight. The acute oral LD50 in mice was found to be greater than 5000 mg/kg bw.

 

An acute oral toxicity study (limit test) was performed with isopropyl myristate (CAS# 111-27-0) according to OECD Guideline 401 (Reijnders, 1988). Groups of 5 male and female fasted Wistar rats received single oral gavage doses of 2000 mg/kg bw. The animals were observed for 14 days after administration. No mortalities occurred. No signs of clinical toxicity were reported. The acute oral LD50 was found to be greater than 2000 mg/kg bw.

 

Single oral gavage administration of isopropyl palmitate (CAS# 142-91-6) at 5000 mg/kg bw to female NMRI mice (Dufour, 1991) had no effects on clinical signs, viability or body weight change in the observation period of 6 days. Although there was a short observation time, the lack of any symptoms within this time gave evidence, that the acute oral LD 50 in mice was greater than 5000 mg/kg bw.

 

The acute oral toxicity of isopropyl oleate (CAS# 112-11-8) was assessed in study performed according to OECD Guideline 423 using the acute toxic class method (Rijcken, 1997). Single oral gavage of 2000 mg/kg bw to three fastened male and female Wistar rats resulted in hunched posture and uncoordinated movements in two females two hours after dosing. No other clinical signs of toxicity and no mortality occurred. Thus, the acute oral LD 50 in rats was found to be greater than 2000 mg/kg bw. 

 

Acute oral toxicity - butyl esters

An acute oral toxicity study (limit test) was performed with butyl stearate (CAS# 123-95-5) equivalent to OECD Guideline 401 (Wallace, 1976). Groups of 5 male and female fasted Albino rats received single oral gavage doses of 4270 mg/kg bodyweight. The animals were observed for 14 days after administration. No mortalities occurred. No signs of clinical toxicity were reported. The acute oral LD50 was calculated to be greater than 4270 mg/kg bodyweight.

 

The acute oral toxicity of fatty acids, C16-18 and C18 unsatd. branched and linear, butyl esters (CAS# 163961-32-8) was assessed in study performed according to OECD Guideline 423 using the acute toxic class method (Sanders, 2002). Single oral gavage dosing of 2000 mg/kg bw to three fastened male and female Sprague-Dawley rats caused no mortality, clinical signs of toxicity, changes in bodyweight gain or gross pathology after a 14 day observation period. Thus, the acute oral LD 50 in rats was found to be greater than 2000 mg/kg bodyweight. 

Acute oral toxicity - 2-ethylhexyl esters

An acute oral toxicity limit test was performed with 2-ethylhexyl oleate (CAS# 26399-02-0) in female NMRI mice (Dufour, 1991). Oral gavage administration of 5000 mg/kg bw of the unchanged test substance caused no mortality, abnormal clinical signs or body weight changes within the observation period of 6 days.

 

Fatty acids, C8-16, 2-ethylhexyl esters (CAS# 135800-37-2) was tested for acute oral toxicity according to EU Method B.1 (Potokar, 1989). Five fastened male and female Wistar rats received single oral gavage doses of the test substance at a concentration of 2000 mg/kg bw. in arachis oil. No mortality, abnormal clinical signs or body weight changes occurred within the observation period of 14 days. Thus, the acute oral LD50 was found to be greater than 2000 mg/kg bw in rats.

 

The acute oral toxicity of fatty acids, C16-18, 2-ethylhexyl esters (CAS# 91031-48-0) was tested in male and female NMRI EOPS mice according to OECD Guideline 471 (Masson, 1985). Administration of 4300 mg/kg bodyweight as single oral gavage dose caused no mortality, abnormal clinical reactions or changes in bodyweight gain. Therefore, the acute oral LD50 in mice was found to be greater than 4300 mg/kg bodyweight. 

In another study oral gavage study with fatty acids, C16-18, 2-ethylhexyl esters (CAS# 91031-48-0) the acute oral LD50 in male CF-1 mice was reported to be greater than 10 g/kg bw (Potokar, 1978) as no mortality occurred on no clinical signs of systemic toxicity occurred. 

 

The acute oral toxicity of 2-ethylhexyl palmitate (CAS# 29806-73-3) was assessed in study performed equivalent to OECD Guideline 401 (Sugar, 1980). Single oral gavage dosing of 2000 mg test substance /kg bodyweight in vegetable oil to three fastened male and female CD-1 rats caused no mortality or clinical signs of toxicity. Thus, the acute oral LD 50 in rats was found to be greater than 2000 mg/kg bw. 

In another oral gavage study with the same substance, 2-ethylhexyl palmitate (CAS# 29806 -73 -3) an acute oral

LD50 > 5 mL/kg bodyweight for male and female NMRI mice was reported (Planchette, 1985).

Acute inhalation toxicity:

An acute inhalation study was performed with isopropyl laurate (CAS# 10233-13-3) according to OECD guideline 436 as acute toxic class method in 3 male and 3 female Crl:WI(Han) rats (van Huygevoort, 2010). The animals were exposed to an analytical concentration of 5.3 mg/L of the test substance for 4 hours nose only in an exposure chamber based on the flow past nose-only inhalation chamber (Am. Ind. Hyg Assoc. J. 44(12): 923-928, 1983). An aerosol was generated by nebulization of the test substance by means of a nebulizer (type 950, Hospitak Inc.). No mortalities were reported during the exposure or within the 14 days observation period. Hunched posture was shown by all animals at 1 and 3 hours after exposure. No clinical signs were noted during exposure. Additionally body weight gain in males and females was 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. The inhalatory 4-h LC50value of isopropyl laurate in Wistar rats was found to exceed 5 mg/L.

 

An acute inhalation study was performed with Fatty acids, tall-oil, Bu esters (CAS# 67762-63-4) according to OECD guideline 436 as acute toxic class method in 3 male and 3 female Crl:WI(Han) rats (van Huygevoort, 2010). The animals were exposed to an analytical concentration of 5.3 mg/L of the test substance for 4 hours nose only in an exposure chamber based on the flow past nose-only inhalation chamber (Am. Ind. Hyg Assoc. J. 44(12): 923-928, 1983). An aerosol was generated by nebulization of the test substance by means of a nebulizer (type 950, Hospitak Inc.). No mortalities or any abnormal clinical signs were reported during the exposure or within the 14 days observation period. Additionally body weight gain in males and females was within the range expected for rats of this strain and age used in this type of study. Macroscopic post mortem examination of the animals revealed pale discolouration of the lungs of one female. No other abnormalities were noted in any of the animals. The inhalatory 4-h LC50value of Fatty acids, tall-oil, Bu esters in Wistar rats was found to exceed 5 mg/L.

 

An acute inhalation study was performed with 2-ethylhexyl oleate (CAS# 26399-02-0) according to OECD guideline 436 as acute toxic class method in 3 male and 3 female Crl:WI(Han) rats (van Huygevoort, 2010). The animals were exposed to an analytical concentration of 5.7 mg/L of the test substance for 4 hours nose only in an exposure chamber based on the flow past nose-only inhalation chamber (Am. Ind. Hyg Assoc. J. 44(12): 923-928, 1983). An aerosol was generated by nebulization of the test substance by means of a nebulizer (type 950, Hospitak Inc.). No mortalities were reported during the exposure or within the 14 days observation period. Hunched posture was shown by all animals on Day 2 after exposure. No clinical signs were noted during exposure. Additionally body weight gain in males and females was 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. The inhalatory 4-hour LC50 value of 2-ethylhexyl oleate aerosol in Wistar rats was found to exceed 5 mg/L.

 

An acute inhalation toxicity study was performed with Fatty acids, C8-16, 2-ethylhexyl esters (CAS# 135800-37-2) according to OECD Guideline 403. 5 male and female Wistar rats were exposed for 4 hours to 1.49 mg/L test substance aerosol by nose only (Duchosal, 1990). This highest attainable liquid aerosol concentration caused no mortality, clinical signs, body weight changes or abnormalities in necropsy within and after the 15 day observation period.

 

Acute dermal toxicity:

An acute dermal toxicity (limit test) was performed on ethyl linoleate (CAS# 544 -35 -4) according to OECD Guideline 402 (Otterdijk, 2010). 5 male and female Wistar rats were exposed to 2000 mg test substance /kg bodyweight for 24 hours on the back skin under occlusive conditions. The observation period was 14 days. Besides Chromodacryorrhoea shown by two animals on day1, no other clinical signs of systemic toxicity were noted in any animal. Body weight gain and necropsy at study termination revealed no abnormalities. Thus, the acute dermal LD50 in rats for ethyl linoleate was found to be greater than 2000 mg/kg bw.

 

An acute dermal toxicity (limit test) was performed with fatty acids, C16-18 and C18-unsatd., branched and linear, Bu esters (CAS# 163961-32-8) according to OECD Guideline 402 (Sanders, 2004). 5 male and female Sprague-Dawley rats were exposed to 2000 mg test substance /kg bodyweight for 24 hours on back and flank skin under semiocclusive conditions. The observation period was 14 days. No deaths, clinical signs of systemic toxicity, changes in bodyweight gain or abnormalities in gross pathology were observed. Based on the study results the acute dermal LD50 in rats was found to be greater than 2000 mg/kg bodyweight. 

Justification for classification or non-classification

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