2-ethyl-2-(hydroxymethyl)-1,3-propanediyl dioleate

Endpoint summary

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route

Endpoint conclusion:

no study available

Effect on fertility: via inhalation route

Endpoint conclusion:

no study available

Effect on fertility: via dermal route

Endpoint conclusion:

no study available

Additional information

Effect on fertility

There are no studies available to assess the potential of the substance 2-Ethyl-2-(hydroxymethyl)-1,3-propanediyl dioleate (CAS 25111-05-1) to induce effects on reproduction. In accordance with Regulation (EC) No 1907/2006, Annex VIII, 8.7.1, column 2, a screening for reproductive/developmental toxicity, one species (OECD 421 or 422) does not need to be conducted if a prenatal developmental toxicity (Annex IX, 8.7.2) or a two-generation reproductive toxicity study (Annex IX, Section 8.7.3) is available. For the substance 2-Ethyl-2-(hydroxymethyl)-1,3-propanediyl dioleate data on prenatal developmental toxicity are available for the structural related substance Decanoic acid, ester with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol octanoate (CAS 11138-60-6) which did not show an influence on the observed fertility parameters.

Short description of key information:
No study available

Effects on developmental toxicity

Description of key information

Dermal (OECD 414), rat: NOAEL >= 2000 mg/kg bw/day

Effect on developmental toxicity: via oral route

Endpoint conclusion:

no study available

Effect on developmental toxicity: via inhalation route

Endpoint conclusion:

no study available

Effect on developmental toxicity: via dermal route

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

The available information comprises an adequate, reliable study (Klimisch score 2) from a reference substance with similar structure and intrinsic properties. Read-across is justified based on common origin, common precursors and breakdown products of hydrolysis and consistent trends in environmental fate, ecotoxicological and toxicological profile (refer to endpoint discussion for further details). The selected study is thus sufficient to fulfil the standard information requirements set out in Annex IX, 8.7, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006.

Additional information

Effect on developmental toxicity

Justification for grouping of substances and read-across

There are no data available for developmental toxicity of 2-Ethyl-2-(hydroxymethyl)-1,3-propanediyl dioleate (CAS 25111-05-1). In order to fulfil the standard information requirements set out in Annex VIII, 8.7.1 and Annex XI, 8.7.2, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006, read-across from structurally related substance 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 for developmental toxicity

CAS	NOAEL [mg/kg bw/day]
25111-05-1 Target substance	RA: CAS 11138-60-6
11138-60-6	Systemic ≥2000 mg/kg bw/day (rat) Local 200 mg/kg bw/day

 

The above mentioned substance is 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 2-Ethyl-2-(hydroxymethyl)-1,3-propanediyl dioleate (CAS 25111-05-1).

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

CAS 11138-60-6

Fatty acids, C8 -C10 (even numbered), di- and triesters with propylidynetrimethanol (CAS 11138-60-6) was tested in a prenatal developmental toxicity study comparable to OECD Guideline 414 (Azuka and Daston, 2004). The test substance was percutaneously applied to Sprague-Dawley rats for 6 h/day under occlusive conditions. 25 animals per sex per dose were treated with 200, 600 or 2000 mg/kg bw/day in corn oil on Days 6-15 of gestation. Control animals (25 per sex per dose) received the vehicle. The middle and the high dose levels caused some local irritation at the site of application, but no decreases in maternal weight gain or food consumption. There were no differences from control in any of the developmental parameters measured, including embryo/fetal viability, fetal weight, malformations, or variations. Therefore, a NOAEL of 2000 mg/kg bw/day was derived for prenatal development and for systemic maternal toxicity. Due to the irritation effects on skin, the local maternal NOAEL was found to be 200 mg/kg bw/day.

Justification for selection of Effect on developmental toxicity: via dermal route:
Hazard assessment is conducted by means of read-across from a structural analogue. The available study is 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 the structurally similar substance, the available data on toxicity to reproduction 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.