Decyl 2-ethylhexanoate

Endpoint summary

Description of key information

Oral (OECD 401): LD50 > 2000 mg/kg bw
Inhalation (OECD 436): LC50 > 5.7 mg/L

Dermal: no data available

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

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(s), common precursors/breakdown products and similarities in PC/ECO/TOX properties (refer to endpoint discussion for further details).
Taken together, the information from these independent sources is consistent and provides sufficient weight of evidence for hazard assessment leading to an endpoint conclusion in accordance with Annex XI, 1.2, of Regulation (EC) No 1907/2006. Therefore, the available information as a whole is 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

Dose descriptor:

LC50

Value:

5.7 mg/m³ air

Quality of whole database:

The available information comprises adequate, reliable (Klimisch score 2 due to read across) and consistent studies from reference substances with similar structure and intrinsic properties. Read-across is justified based on common precursors and breakdown products of hydrolysis and consistent trends in environmental fate, ecotoxicological and toxicological profile (refer to the endpoint discussion for further details).
The selected study is thus sufficient to fulfil the standard information requirements set out in Annex 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 study available

Additional information

Acute toxicity

 

Justification for read-across

There are no data for acute toxicity available for Decyl 2-Ethylhexanoate (CAS 93777-46-9). To fulfil the standard data requirements defined in Regulation (EC) No 1907/2006, Annex VIII, 8.5, read-across from appropriate substances is conducted in accordance with Regulation (EC) No 1907/2006, Annex XI, 1.5.

According to 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) “to avoid the need to test every substance for every endpoint”.

 

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 substances are the basis of read-across. A detailed justification for the analogue read- across approach is provided in the technical dossier (see IUCLID Section 13).

As no experimental/measured data are available on acute toxicity of Decyl 2-Ethylhexanoate (CAS 93777-46-9) following the oral, dermal or inhalation route, read-across to reliable data on the analogue substances Hexadecyl 2-ethylhexanoate (CAS 59130-69-7), Fatty acids, C8-16, 2-ethylhexyl esters (CAS 135800-37-2) and 2-ethylhexyl oleate (CAS 26399-02-0) was conducted.

 

Acute oral toxicity

CAS 59130-69-7

Acute toxicity was evaluated in a limit test performed according to OECD guideline 401 and GLP (Pittermann, 1991). Five rats per sex and dose received an oral dose of 2000 mg/kg bw substance per gavage. As no mortality and no systemic toxicity was found during the 14-days observation period, the LD50 was estimated to be >2000 mg/kg bw.

 

CAS 135800-37-2

Fatty acids, C8-16, 2-ethylhexyl esters 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.

Acute toxicity following inhalation

CAS 26399-02-2

Toxicity via inhalation of 2-ethylhexyl oleate, which was tested in a study performed according to OECD guideline 436 and GLP (Huygevoort, 2010). Three male and female Crl:WI (Han) rats were nose-only exposed to an aerosol of an analytical concentration of 5.7 mg/L for 4 h. Apart from hunched position observed in all animals on Day 2 after exposure, no further signs of toxicity and no mortality were observed until the end of the 14 day observation period. Thus, the LC50 was considered to be >5.7 mg/L.

 

CAS 135800-37-2

Acute toxicity ofFatty acids, C8-16, 2-ethylhexyl esters was tested according to OECD Guideline 403 and GLP (Duchosal, 1989). 5 animals/sex were exposed nose only to 1.49 mg/L test substance over 4 hours. No mortality and no clinical signs of toxicity were observed until the end of the 15 day observation period. All animals gained weight during the observation period. No gross pathological findings were observed during necropsy. Thus, a LC50 value > 1.49 mg/L was derived in the conducted study.

Acute dermal toxicity

No data on acute toxicity following dermal exposure are available forDecyl 2-Ethylhexanoate (CAS 93777-46-9). No data are included in the dossier as dermal absorption is considered negligible. Further,the substance does not meet the criteria for classification as acute toxicity or STOT SE after oral exposure and no systemic effects have been observed in in vivo studies with dermal exposure. Additionally, no adverse effects have been observed in the repeated dose toxicity studies, thereby supporting that the substance does not possess hazardous properties. Thus, testing by the dermal route is not considered appropriate in accordance with Column 2 of Annex VIII, Section 8.5.

Overall conclusion

In summary, reliable data available for the read-across analogue substances indicate a very low level of acute toxicity following the oral or inhalation route as the defined LD50/LC50 values exceed the currently applied limit values and/or no adverse effects at the applied doses have been observed. Thus, as the available data did not identify any hazard for acute oral and inhalation toxicity, Decyl 2-Ethylhexanoate (CAS 93777-46-9) is not considered as hazardous after acute exposure.

Justification for classification or non-classification

Based on the analogue read-across approach, the available data on acute toxicity do not meet the classification criteria according to Regulation (EC) 1272/2008, and are therefore conclusive but not sufficient for classification.