Registration Dossier

Administrative data

Description of key information

Acute toxicity: Oral LD50 (rat, m): > 5000mg/kg bw (similar to OECD 401, analogue approach)
Acute toxicity: Inhalation LC50 (rat, m/f) > 5.3 mg/L (OECD 436; analogue approach)
Acute toxicity: Dermal LD50 (rat, m/f): > 2000 mg/kg bw (OECD 402, analogue approach)

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
The available information comprises an adequate, reliable (Klimisch score 2) study from a reference substance with similar structure and intrinsic properties. Read-across is justified based on common functional group, common precursors/breakdown products and similarities in physicochemical and toxicological properties (refer to endpoint discussion for further details). The selected study is thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
The available information comprises adequate, reliable (Klimisch score 2) studies from reference substances with similar structure and intrinsic properties. Read-across is justified based on common functional group, common precursors/breakdown products and similarities in physicochemical and toxicological properties (refer to endpoint discussion for further details). The selected study is thus sufficient to fulfil the standard information requirements set out in Annex VII-VIII, 8.5, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006.

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
The available information comprises adequate, reliable (Klimisch score 2) studies from reference substances with similar structure and intrinsic properties. Read-across is justified based on common functional group, common precursors/breakdown products and similarities in physicochemical and toxicological properties (refer to endpoint discussion for further details). The selected study is thus sufficient to fulfil the standard information requirements set out in Annex VII-VIII, 8.5, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006.

Additional information

Justification for grouping of substances and read-across

There are no data available for acute toxicity of Fatty acids, C8-10, octyl esters (CAS 91031-98-0). In order to fulfil the standard information requirements set out in Regulation (EC) No 1907/2006, Annex VIII, 8.5, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006, a read-across from structurally related substances was conducted.

In accordance with Article 13 (1) of Regulation (EC) No 1907/2006, "information on intrinsic properties of substances may be generated by means other than tests, provided that the conditions set out in Annex XI are met.” In particular for human toxicity, information shall be generated whenever possible by means other than vertebrate animal tests, which includes the use of information from structurally related substances (grouping or read-across).

Having regard to the general rules for grouping of substances and read-across approach laid down in Annex XI, Item 1.5, of Regulation (EC) No 1907/2006 whereby substances may be predicted as similar provided that their physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity.

 

Overview of acute toxicity

CAS #

Acute oral

Acute inhalation

Acute dermal

91031-98-0 Target substance

RA: 2306-88-9

RA: 26399-02-0

RA: 67762-63-4

RA: 10233-13-3

RA: 544-35-4

RA: 163961-32-8

2306-88-9

LD50 > 5000 mg/kg bw

--

--

26399-02-0

--

LC50 > 5.7 mg/L

--

67762-63-4

--

LC50 > 5.3 mg/L

--

10233-13-3

--

LC50 > 5.3 mg/L

--

544-35-4

--

--

LD50 > 2000 mg/kg bw

163961-32-8

 

 

LD50 > 2000 mg/kg bw

 

 

The above mentioned substances are considered to be similar on the basis of structural similarity resulting in similar properties and/or activities. The available endpoint information is used to predict the same endpoints for Fatty acids, C8-10, octyl esters (CAS 91031-98-0).

A detailed analogue approach justification is provided in the technical dossier (see IUCLID Section 13).

 

Acute oral toxicity:

CAS 2306-88-9

An acute oral toxicity study withoctyl octanoate (CAS 2306-88-9) representing a main component of Fatty acids, C8-10, octyl esters, similar to OECD Guideline 401 was performed (Potokar, 1981). A group of 10 male Wistar rats received single oral doses of 1000 or 5000 mg/kg bw. No mortalities were observed during the study period. No signs of clinical toxicity were reported. All animals showed the expected gain in body weight. Based on these data, the acute oral LD50 in rats was found to be greater than 5000 mg/kg bw.

Acute inhalation toxicity:

CAS 26399-02-0

An acute inhalation toxicity study (limit test) according to OECD Guideline 436 was performed with 2-ethylhexyl oleate (CAS 26399-02-0) (Huygevoort, 2010). A group of 3 male and female Crl:WI (Han) rats inhaled a single concentration of 5.7 mg/L air as aerosol for 4 h. No mortalities were observed during the study period. No clinical signs were noted during exposure. Hunched posture was shown by all animals on Day 2 after exposure. All animals showed the expected gain in bodyweight. No abnormalities were found at macroscopic post mortem examination of the animals. The acute LC50 for inhalation in rats was found to be greater than 5.7 mg/L air.

CAS 67762-63-4

An acute inhalation toxicity study (limit test) according to OECD Guideline 436 was performed with Fatty acids, tall-oil, butyl esters (CAS 67762-63-4) (Huygevoort, 2010). A group of 3 male and female Crl:WI (Han) rats inhaled a single concentration of 5.3 mg/L air as aerosol for 4 h. No mortalities were observed during the study period. No clinical signs were noted during exposure. All animals showed the expected gain in bodyweight. 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 acute LC50 for inhalation in rats was found to be greater than 5.3 mg/L air.

CAS 10233-13-3

An acute inhalation toxicity study (limit test) according to OECD Guideline 436 was performed with isopropyl laurate (CAS 10233-13-3) (Huygevoort, 2010). A group of 3 male and female Crl:WI (Han) rats inhaled a single concentration of 5.7 mg/L air as aerosol for 4 h (nose only). No mortalities were observed during the study period. No clinical signs were noted during exposure. Hunched posture was observed in all animals 1 and 3 hours after exposure. All animals showed the expected gain in bodyweight. No abnormalities were observed at macroscopic post mortem examination of the animals. The acute LC50 for inhalation in rats was found to be greater than 5.7 mg/L air.

Acute dermal toxicity:

CAS 544-35-4

An acute dermal toxicity study (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 bw 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 study (limit test) was performed on Fatty acids, C16-18 and C18 unsatd. branched and linear, butyl 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 bw for 24 hours on the back and flanks skin under semiocclusive conditions. The observation period was 14 days. No mortality occurred during the study period. No signs of systemic toxicity and no signs of dermal irritation were observed up to the end of the observation period. Body weight gain appeared normal except for one female which showed a body weight loss in the first week but expected body weight gain during the second week. Necropsy revealed no substance-related findings. Thus, the acute dermal LD50 in rats was found to be greater than 2000 mg/kg bw.

 

Conclusion:

Thus, the available data indicate no hazard for acute toxicity for Fatty acids, C8-10, octyl esters (CAS 91031-98-0).

One study is available investigating the acute oral toxicity ofoctyl octanoate (CAS 2306-88-9) representing a main component of Fatty acids, C8-10, octyl esters. The study resulted in an oral LD50 value greater than 5000 mg/kg bw. Three studies from structural analaogue substances are available investigating the acute inhalation toxicity of 2-ethylhexyl oleate (CAS 26399-02-0), Fatty acids, tall-oil, butyl esters (CAS 67762-63-4) and isopropyl laurate (CAS 10233-13-3) resulting in LC50 values for inhalation of 5.7 mg/L air (for 2-ethylhexyl oleate (CAS 26399-02-0) and 5.3 mg/L air for Fatty acids, tall-oil, butyl esters (CAS 67762-63-4) and isopropyl laurate (CAS 10233-13-3). Acute dermal toxicity data from ethyl linoleate (CAS 544-35-4) and Fatty acids, C16-18 and C18 unsatd. branched and linear, butyl esters (CAS 163961-32-8) showed no effects at the limit dose of 2000 mg/kg bw.


Justification for selection of acute toxicity – oral endpoint
Hazard assessment is conducted by means of read-across from structural analog. The available study is adequate and reliable based on the identified similarities in structure and intrinsic properties between source and target substance and overall quality assessment (refer to the endpoint discussion for further details).

Justification for selection of acute toxicity – inhalation endpoint
Hazard assessment is conducted by means of read-across from structural analogues. The available studies are adequate and reliable based on the identified similarities in structure and intrinsic properties between source and target substances and overall quality assessment (refer to the endpoint discussion for further details).

Justification for selection of acute toxicity – dermal endpoint
Hazard assessment is conducted by means of read-across from structural analogues. The available studies are adequate and reliable based on the identified similarities in structure and intrinsic properties between source and target substances and overall quality assessment (refer to the endpoint discussion for further details).

Justification for classification or non-classification

Based on read-across from structurally similar substances, the available data on oral, inhalation and dermal toxicity do not meet the classification criteria according to Regulation (EC) 1272/2008 and are therefore conclusive but not sufficient for classification.