Registration Dossier

Administrative data

Description of key information

All available acute oral toxicity studies within this category resulted in an acute oral LD50 > 2000 mg/kg bw.

All available acute dermal toxicity studies within the category resulted in acute dermal LD50 > 2000 mg/kg bw.

All available acute inhalation toxicity studies within the category resulted in acute inhalation LC50 > 5.3 mg/L air.

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

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Additional information

Justification for grouping of substances and read-across

The Short Chain Alcohol Esters (SCAE C2-C8) category covers esters from a fatty acid (C8-C29) and a C2-C8 alcohol (ethanol, isopropanol, butanol, isobutanol, pentanol, iso-pentanol, hexanol, 2-ethylhexanol or octanol). This category includes both well-defined mono-constituent substances as well as related UVCB substances with varying fatty acid chain lengths.

The available data allows for an accurate hazard and risk assessment of the category and the category concept is applied for the assessment of environmental fate, environmental and human health hazards. Thus where applicable, environmental and human health effects are predicted from adequate and reliable data for source substance(s) within the group by interpolation to the target substances in the group (read-across approach) applying the group concept in accordance with Annex XI, Item 1.5, of Regulation (EC) No 1907/2006. In particular, for each specific endpoint the source substance(s) structurally closest to the target substance is/are chosen for read-across, with due regard to the requirements of adequacy and reliability of the available data. Structural similarities and similarities in properties and/or activities of the source and target substance are the basis of read-across.

A detailed justification for the grouping of chemicals and read-across is provided in the technical dossier (see IUCLID Sections 7.1 and 13) and within Chapter 5.1 of the CSR.

 

Overview of acute toxicity

CAS

Acute Oral

Acute Inhalation

Acute Dermal

544-35-4 (b)

LD50 (rat) > 2000 mg/kg bw

--

LD50 (rat) > 2000 mg/kg bw

10233-13-3 (a)

LD50 (mice) > 5000 mg/kg bw

 LC50 (rat) > 5 mg/L

RA: 544-35-4

RA: 163961-32-8

110-27-0 (a)

LD50 (rat) > 2000 mg/kg bw

RA: 10233-13-3

RA: 26399-02-0

RA: 67762-63-4

RA: 544-35-4

RA: 163961-32-8

142-91-6 (a)

LD50 (mice) > 5000 mg/kg bw

RA: 10233-13-3

RA: 26399-02-0

RA: 67762-63-4

RA: 544-35-4

RA: 163961-32-8

68171-33-5 (a)

LD50 (rat) > 2000 mg/kg bw

RA: 10233-13-3

RA: 26399-02-0

RA: 67762-63-4

RA: 544-35-4

RA: 163961-32-8

112-11-8 (a)

LD50 (rat) > 2000 mg/kg bw

RA: 10233-13-3

RA: 26399-02-0

RA: 67762-63-4

RA: 544-35-4

RA: 163961-32-8

91031-58-2 (a)

RA: 142-91-6

RA: 112-10-7

RA: 10233-13-3

RA: 26399-02-0

RA: 67762-63-4

RA: 544-35-4

RA: 163961-32-8

63393-93-1 (a)

LD50 (rat) > 54,400 mg/kg bw

RA: 10233-13-3

RA: 26399-02-0

RA: 67762-63-4

RA: 544-35-4

RA: 163961-32-8

123-95-5 (b)

LD50 (rat) > 4270 mg/kg bw

--

--

67762-63-4 (b)

--

LC50 (rat) > 5 mg/L

--

85408-76-0 (a)

RA: 123-95-5

RA: 163961-32-8

RA: 10233-13-3

RA: 26399-02-0

RA: 67762-63-4

RA: 544-35-4

RA: 163961-32-8

84988-74-9 (a)

LD50 (rat) > 2000 mg/kg bw

RA: 123-95-5

RA: 163961-32-8

RA: 10233-13-3

RA: 26399-02-0

RA: 67762-63-4

RA: 544-35-4

RA: 163961-32-8

163961-32-8 (b)

LD50 (rat) > 2000 mg/kg bw

--

LD50 (rat) > 2000 mg/kg bw

646-13-9 (b)

LD50 (mice) > 5000 mg/kg bw

--

--

85865-69-6 (a)

RA: 646-13-9

RA: 84988-79-4

RA: 10233-13-3

RA: 26399-02-0

RA: 67762-63-4

RA: 544-35-4

RA: 163961-32-8

84988-79-4 (a)

LD50 (rat) > 2000 mg/kg bw

RA: 10233-13-3

RA: 26399-02-0

RA: 67762-63-4

RA: 544-35-4

RA: 163961-32-8

6309-51-9 (a)

 

RA: 10233-13-3

RA: 34316-64-8

RA: 10233-13-3

RA: 26399-02-0

RA: 67762-63-4

RA: 544-35-4

RA: 163961-32-8

1365095-43-7 (a)

 

RA: 2306-88-9

RA: 20292-08-4

RA: 135800-37-2

RA: 10233-13-3

RA: 26399-02-0

RA: 67762-63-4

RA: 544-35-4

RA: 163961-32-8

34316-64-8 (a)

LD50 (mice) > 4300 mg/kg bw

RA: 10233-13-3

RA: 26399-02-0

RA: 67762-63-4

RA: 544-35-4

RA: 163961-32-8

2306-88-9 (a)

 

LD50 (rat) > 5000 mg/kg bw

RA: 10233-13-3

RA: 26399-02-0

RA: 67762-63-4

RA: 544-35-4

RA: 163961-32-8

59587-44-9 (a)

RA: 92044-87-6

RA: 135800-37-2

RA: 10233-13-3

RA: 26399-02-0

RA: 67762-63-4

RA: 544-35-4

RA: 163961-32-8

20292-08-4 (a)

LD50 (rat) > 2000 mg/kg bw

RA: 10233-13-3

RA: 26399-02-0

RA: 67762-63-4

RA: 544-35-4

RA: 163961-32-8

649747-80-8 (a)

 

RA: 2306-88-9

RA: 20292-08-4

RA: 135800-37-2

RA: 10233-13-3

RA: 26399-02-0

RA: 67762-63-4

RA: 544-35-4

RA: 163961-32-8

135800-37-2 (b)

LD50 (rat) > 2000 mg/kg bw

LC50 (rat) > 1.49 mg/L

--

29806-73-3 (a)

LD50 (rat) > 2000 mg/kg bw

RA: 10233-13-3

RA: 26399-02-0

RA: 67762-63-4

RA: 544-35-4

RA: 163961-32-8

22047-49-0 (a)

LD50 (mice) > 4300 mg/kg bw

RA: 10233-13-3

RA: 26399-02-0

RA: 67762-63-4

RA: 544-35-4

RA: 163961-32-8

92044-87-6 (a)

LD50 (rat) > 5000 mg/kg bw

RA: 10233-13-3

RA: 26399-02-0

RA: 67762-63-4

RA: 544-35-4

RA: 163961-32-8

91031-48-0 (a)

LD50 (mice) > 4300 mg/kg bw

RA: 10233-13-3

RA: 26399-02-0

RA: 67762-63-4

RA: 544-35-4

RA: 163961-32-8

85049-37-2 (a)

LD50 > 17,200 mg/kg bw

RA: 26399-02-0

RA: 10233-13-3

RA: 26399-02-0

RA: 67762-63-4

RA: 544-35-4

RA: 163961-32-8

93572-14-6 (a)

RA: 29806-73-3

RA: 22047-49-0

RA: 91031-48-0

RA: 10233-13-3

RA: 26399-02-0

RA: 67762-63-4

RA: 544-35-4

RA: 163961-32-8

26399-02-0 (b)

LD50 (mice) > 5000 mg/kg bw

LC50 (rat) > 5 mg/L

--

(a) Category members subject to the REACh Phase-in registration deadline of 31 May 2013 are indicated in bold font.

(b) Substances that are either already registered under REACh, or not subject to the REACh Phase-in registration deadline of 31 May 2013, are indicated in normal font.

For all category members registered under REACh a full data set for each endpoint is provided. For substances not subject to the current REACh Phase-in registration, lack of data for a given endpoint is indicated by "--".

Discussion

Acute oral toxicity - isopropyl esters

CAS 10233-13-3

An acute oral toxicity study (limit test) with isopropyl laurate (CAS No. 10233-13-3) similar to OECD Guideline 401 was performed (Dufour, 1991). A group of 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 were observed during the study period. 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.

 

CAS 110-27-0

Three studies investigating the acute toxicity via the oral route of isopropyl myristate are available (CAS No. 110-27-0).

An acute oral toxicity study (limit test) was performed with isopropyl myristate (CAS No. 110-27-0) 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.

 

Another acute oral toxicity study with isopropyl myristate CAS No. 110-27-0) was performed comparable to OECD Guideline 401 (Green, 1975). The test substance was administered by oral gavage unchanged to groups of five male and female rats at 5 mL/kg body weight. The animals were observed for 14 days after administration. No mortalities occurred. No signs of clinical toxicity were reported. Thus, based on the LD50 > 4300 mg/kg bw (5 mL/kg body weight), classification for acute oral toxicity is not warranted

 

In an acute oral toxicity study (comparable to OECD 401) performed with isopropyl myristate, 5 female NMRI mice received the test substance per gavage at the limit dose of 5000 mg/kg bw (Dufour, 1991). No mortality occurred during the observation period of 6 days. No clinical signs were observed up to the end of the observation period. Thus, based on the LD50 > 5000 mg/kg bw, classification for acute oral toxicity is not warranted.

CAS 142-91-6 

Single oral gavage administration of isopropyl palmitate (CAS No. 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 LD50 in mice was greater than 5000 mg/kg bw.

CAS 68171-33-5

An acute oral toxicity study (limit test) was performed with isopropyl isostearate (CAS No. 68171-33-5) according to OECD Guideline 401 (Saboureau, 1989). Groups of 5 male and female fasted Sprague-Dawley rats received single oral gavage doses of 2000 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 destimated to be greater than 2000 mg/kg bodyweight.

CAS 112-11-8 

The acute oral toxicity of isopropyl oleate (CAS No. 112-11-8) was assessed in a study performed according to OECD Guideline 423 using the acute toxic class method (Rijcken, 1997). A single oral gavage of 2000 mg/kg bw to three fasted 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. 

 

CAS 112-10-7

A study for acute oral toxicity of isopropyl stearate (CAS No.112-10-7) was performed in NMRI mice similarly to OECD guideline 401 (Masson, 1986). A group of 5 females was treated with the limit dose of 4300 mg/kg bw (= 5 mL/kg bw, based on a density of 0.87 g/mL) of the undiluted test substance. During the study period, no mortality and no clinical signs of toxicity were observed in any animal. Therefore, the oral LD50 in male and female rats was greater than 4300 mg/kg bw.

 

 

CAS 63393-93-1

A study for acute oral toxicity of isopropyl lanolate (CAS No. 63393-93-1)was performed in rats comparable to OECD guideline 401 (Paul, 1970). Groups of 10 albino rats (5 males and 5 females) were dosed with 2, 4, 8, 16, 32 and 64 mL/kg bw of the unchanged test material by gavage. The animals were observed for a period of 14 days following administration. During the study period, no mortality occurred in any animal. The animals of the 2 highest dosage levels (32 and 64 mL/kg bw) exhibited passive behavior patterns and had mild diarrhoea. Therefore, under the conditions of this study, the oral LD50 in male and female rats was greater than 64 mL/kg bw (=54,400 mg/kg bw, based on a density of 0.85 g/mL).

 

Another study in which the acute oral toxicity of isopropyl lanolate in a 2%-formulation was studied in rats similar to OECD guideline 401 is available (CTFA, 1977). The test material was administered by gavage at a dose of 100 mL/kg bw (equivalent to 92530 mg/kg bw, based on a density of 0.9253 g/mL) in an oil-in-water emulsion. No mortalities, no clinical signs and no abnormalities in body weight were observed during the 14-day observation period.Macroscopic post mortem examination of the animals revealedbrown mottled kidneys in one male rat. Thus, the LD50 of the active ingredient was found to be greater than 1850.6 mg/kg bw.

 

Acute oral toxicity - butyl esters

CAS 84988-79-4

Fatty acids, C16-18 and C18 unsatd. , isobutyl esters (CAS No. 84988-79-4) was tested for acute oral toxicity similarly to OECD Guideline 401 (Potokar, 1986). Two male and female Wistar rats received single oral gavage doses of the test substance at a dose level of 2000 mg/kg bw. in peanut 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.

CAS 123-95-5

An acute oral toxicity study (limit test) was performed with butyl stearate (CAS No. 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 estimated to be greater than 4270 mg/kg bodyweight.

 

CAS 163961-32-8 

The acute oral toxicity of fatty acids, C16-18 and C18 unsatd. branched and linear, butyl esters (CAS No. 163961-32-8) was assessed in a study performed according to OECD Guideline 423 (Sanders, 2002). Single oral gavage dosing of 2000 mg/kg bw to three fasted 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. 

CAS 646-13-9

For isobutyl stearate (CAS No. 646-13-9), a study according to OECD 401 (Dufour, 1993) was conducted. Five male and female NMRI mice were orally exposed to a single dose of 5000 mg/kg bw. There were no deaths or signs of toxicity during the study observed. The body weight gain was not influenced during the observation period of 14 days. Gross examination of organs and tissues at necropsy did not reveal any abnormalities.

Acute oral toxicity - hexyl esters

CAS 34316-64-8

A study for acute oral toxicity of hexyl laurate (CAS No.34316-64-8) is available (Masson, 1987). The study was performed equivalently to OECD guideline 401 in a group of 5 male NMRI mice, treated with the limit dose of 4300 mg/kg bw (converted from 5 mL/kg bw, based on a density of 0.87 g/mL) of the unchanged test substance by gavage. No mortality occurred and no clinical signs of toxicity were observed up to the end of the observation period in all animals. Therefore, under the conditions of this study, the oral LD50 in male NMRI mice was greater than 4300 mg/kg bw.

Acute oral toxicity - 2-ethylhexyl esters

CAS 20292-08-4

The acute oral toxicity of 2-ethylhexyl laurate (CAS No. 20292-08-4) was tested in female Swiss mice comparable to OECD Guideline 401 (Bouffechoux, 1996). Administration of 2000 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 2000 mg/kg bodyweight. 

CAS 29806-73-3 

Three reliable studies investigating the acute toxicity via the oral route of 2-ethylhexyl palmitateare available(CAS No. 29806-73-3). The acute oral toxicity of 2-ethylhexyl palmitate was assessed in study performed equivalently to OECD Guideline 401 (Sugar, 1980). Single oral gavage dosing of 2000 mg test substance /kg bodyweight in vegetable oil to three fasted male and female CD-1 rats caused no mortality or clinical signs of toxicity. Thus, the acute oral LD50 in rats was found to be greater than 2000 mg/kg bw. 

In another oral gavage study with the same substance, 2-ethylhexyl palmitate an acute oral LD50 > 5 mL/kg body weight for male and female NMRI mice was reported (Planchette, 1985).

In the third study (Green, 1972), 5 male and female Albino rats were orally treated with undiluted 2-ethylhexyl palmitate at 2000, 4000, 8000, 16,000, 32,000 and 64,000 mg/kg bw. No mortality occurred during the 14 day observation period. Animals dosed at 16,000 mg/kg bw and below did not exhibit any toxic effects. At 32,000 mg/kg bw wet, unkempt coat and mild diarrhoea were noted. These effects were reversible within 48 hours.

At 64,000 mg/kg bw slight ocular haemorrhage accompanied with moderate diarrhoea were noted. The coat of the animals appeared wet and unkempt for 5 days following treatment.

 

CAS 22047-49-0

2-ethylhexyl stearate (CAS No. 22047-49-0) was tested for acute oral toxicity similarly to OECD guideline 401 (Masson, 1985). Five male and female NMRI mice received single oral gavage doses of the test substance at a dose level of 4300 mg/kg bw. No mortality, abnormal clinical signs occurred within the observation period. Thus, the acute oral LD50 was found to be greater than 4300 mg/kg bw in mice.

CAS 91031-48-0

The acute oral toxicity of fatty acids, C16-18, 2-ethylhexyl esters (CAS No. 91031-48-0) was tested in male and female NMRI EOPS mice according to OECD Guideline 401 (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 a second study (Potokar, 1978), 10 male CF-1 mice were orally treated with 10,000 mg/kg bw. No mortality occurred and no only clinical signs were noted during the 8 day observation period. Thus, the acute oral LD50 was found to be greater than 10,000 mg/kg bw in mice.

CAS 135800-37-2

Fatty acids, C8-16, 2-ethylhexyl esters (CAS No. 135800-37-2) was tested for acute oral toxicity according to EU Method B.1 (Potokar, 1989). Five male and female Wistar rats received single oral gavage doses of the test substance at a dose level 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.

CAS 92044-87-6

Two studies investigating the acute toxicity via the oral route of fatty acids, coco, 2-ethylhexyl esters are available (CAS No. 92044-87-6).

An acute oral toxicity study (limit test) was performed with fatty acids, coco, 2-ethylhexyl esters according to OECD Guideline 401 under GLP conditions (Reijnders, 1987). 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 and no signs of clinical toxicity were reported. No abnormalities were found at macroscopic post mortem examination of the animals. The acute oral LD50 was found to be greater than 2000 mg/kg bw.

Another study in which the acute oral toxicity offatty acids, coco, 2-ethylhexyl esterswas studied in NMRI mice similarly to OECD guideline 401 is available (Masson, 1985). The test material was administered at a single dose of 4300 mg/kg bw (equivalent to 5 mL/kg bw, based on a density of 0.87 g/mL). No mortalities and no clinical signs were observed during the observation period. Therefore, under the conditions of this study, the oral LD50 in male and female mice was greater than 4300 mg/kg bw.

 

CAS 84988-79-4

A study for acute oral toxicity of fatty acids, C16-18 and C18 unsatd. isobutyl esters (CAS No.84988-79-4) is available (Potokar, 1986). The study was performed equivalently to OECD guideline 401 under GLP conditions in a group of 4 Wistar rats (2 males and 2 females), treated with the limit dose of 2000 mg/kg bw of the test substance in peanut oil by gavage. No mortality occurred and no clinical signs of toxicity were observed up to the end of the 15-day observation period in male animals. Only slight pilo-erection was observed 1 - 2.5 hours after application. No further clinical signs were observed. No effect on body weight was noted and pathology of male animals revealed no substance-related findings.

Therefore, under the conditions of this study, the oral LD50 in male and female rats was greater than 2000 mg/kg bw.

 

CAS 26399-02-0

An acute oral toxicity limit test was performed with 2-ethylhexyl oleate (CAS No. 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.

CAS 2306-88-9

Octyl octanoate (CAS No. 2306-88-9) was tested for acute oral toxicity similarly to OECD guideline 401 (Potokar, 1981). Ten male Wistar rats received single oral gavage doses of the test substance at dose levels of 1000 and 5000 mg/kg bw. 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 5000 mg/kg bw in rats.

Acute inhalation toxicity:

CAS 10233-13-3

An acute inhalation study was performed with isopropyl laurate (CAS No. 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 5.3 mg/L.

 

CAS 67762-63-4

An acute inhalation study was performed with Fatty acids, tall-oil, Bu esters (CAS No. 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 LC50-value of Fatty acids, tall-oil, Bu esters in Wistar rats was found to exceed 5.3 mg/L.

 

CAS 26399-02-0 

An acute inhalation study was performed with 2-ethylhexyl oleate (CAS No. 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 5.7 mg/L.

 

Acute dermal toxicity:

CAS 544-35-4

An acute dermal toxicity (limit test) was performed on ethyl linoleate (CAS No. 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 Day 1, 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.

 

CAS 163961-32-8 

An acute dermal toxicity (limit test) was performed with fatty acids, C16-18 and C18-unsatd., branched and linear, Bu esters (CAS No. 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. 

 

Conclusion for acute toxicity

In summary, several studies are available studying the acute oral toxicity of SCAE C2-C8 Category members resulting in oral LD50 values greater than 2000 mg/kg bw. For acute inhalation toxicity three studies are available within the SCAE C2-C8 Category. From these studies a LC50 value of > 5 mg/L was determined. Acute dermal toxicity data from two category members consistently showed no effects at the limit dose of 2000 mg/kg bw.

Thus, the available data indicate a very low level of acute toxicity for the category members and thus no hazard for acute oral, inhalative and dermal toxicity was identified.

A detailed reference list is provided in the technical dossier (see IUCLID, section 13) and within CSR.

Justification for classification or non-classification

According to Article 13 of Regulation (EC) No. 1907/2006 "General Requirements for Generation of Information on Intrinsic Properties of substances", information on intrinsic properties of substances may be generated by means other than tests e.g. from information from structurally related substances (grouping or read-across), provided that conditions set out in Annex XI are met.

Annex XI, "General rules for adaptation of this standard testing regime set out in Annexes VII to X” states that “substances whose physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity may be considered as a group, or ‘category’ of substances. This avoids the need to test every substance for every endpoint".

Since the group concept is applied to the members of the SCAE C2-C8 category, data will be generated from representative reference substance(s) within the category to avoid unnecessary animal testing. Additionally, once the group concept is applied, substances will be classified and labeled on this basis.

Therefore, based on the group concept, the available data on acute toxicity do not meet the classification criteria according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification.