Fatty acids, C18 (saturated and unsaturated) ethyl esters

Endpoint summary

Description of key information

No acute toxicity studies available. Based on the inherent properites of fatty acids, C18 (saturated and unsaturated) ethyl esters and also taking into account the LD50 > 5000 mg/kg bw and LD50 > 2000 mg/kg bw for acute oral and dermal toxicity, respectively for the read-across substance CAS No 67762-38-3 (see attached waiving and justification document in section 13), fatty acids, C18 (saturated and unsaturated) ethyl esters seems to be of low oral and dermal toxicity. The inhalational exposure route is not relevant.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Justification for selection of acute toxicity – oral endpoint

Fatty acids, C18 (saturated and unsaturated) ethyl esters consists primarily of ethyl esters of saturated and unsaturated C18-fatty acids, all of which is considered to be of low acute oral toxicity. In general, hydrolysis results in fatty acids and alcohols (ethanol), te ethanol being biotransformed into the corresponding acids (and acetic acid). The fatty acids are virtually without toxic effect. Fatty acids extracted from natural sources are included in REACH Annex V, point 9 and thus are excluded from registration in accordance with REACH Article 2(7)(b). Taken together, fatty acids, C18 (saturated and unsaturated) ethyl esters and the hydrolysis products seems to be of low oral toxicity, also seen from the read-cross substance used for this registration (CAS No 67762-38-3), where a LD50 > 5000 mg/kg bw was established. Thus, testing for acute oral toxicity seems scientifically unjustified.

Justification for selection of acute toxicity – inhalation endpoint

Fatty acids, C18 (saturated and unsaturated) ethyl esters) has very low  vapor pressure and melting point.  The potential for generation of inhalable forms is evaluated to be low. Also, the use of fatty acids, C18 (saturated and unsaturated) ethyl esters)  will not result in generation of aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be unlikely to occur. Thus, testing for acute inhalational toxicity seems scientifically unjustified.

Justification for selection of acute toxicity – dermal endpoint

Fatty acids, C18 (saturated and unsaturated) ethyl esters consists primarily of ethyl esters of saturated and unsaturated C18-fatty acids, all of which is considered to be of low acute oral toxicity. Topically applied fatty acid ethyl esters can penetrate to the living cells of normal epidermis, enter into metabolism and significantly modify endogenous epidermal lipids. In general, hydrolysis results in fatty acids and alcohols (ethanol), te ethanol being biotransformed into the corresponding acids (and acetic acid). The fatty acids are virtually without toxic effect. Fatty acids extracted from natural sources are included in REACH Annex V, point 9 and thus are excluded from registration in accordance with REACH Article 2(7)(b). Taken together, fatty acids, C18 (saturated and unsaturated) ethyl esters and the hydrolysis products seems to be of low oral toxicity, also seen from the read-cross substance used for this registration (CAS No 67762-38-3), where a LD50 > 2000 mg/kg bw was established. Thus, testing for acute dermal toxicity seems scientifically unjustified.

Justification for classification or non-classification

From the available data on acute toxicity for the read-across substance CAS No 67762 -38 -3 (see attached waiving and justification document in section 13), no classification apply for Fatty acids, C18 (saturated and unsaturated) ethyl esters).