Ethyl palmitate

Endpoint summary

Key value for chemical safety assessment

Effects on fertility

Description of key information

Based on the available study, and on the category approach, the target substance was not considered as reprotoxic. Hence, ethyl palmitate did not required hazard classification for reprotoxicity according to CLP criteria.

Link to relevant study records

Reference

Endpoint:

screening for reproductive / developmental toxicity

Type of information:

read-across based on grouping of substances (category approach)

Adequacy of study:

supporting study

Justification for type of information:

See "Assessment reports" section 13 or "Categories" section for the justification and rationale document for category approach.

Qualifier:

according to guideline

Guideline:

other: 1993 FDA draft "Redbook II" guidelines (Toxicological Principles for the Safety Assessment of Direct Food Additives and Color Additives Used in Food).

Key result

Dose descriptor:

NOAEL

Effect level:

> 5 500 mg/kg bw/day (nominal)

Based on:

test mat.

Sex:

male/female

Basis for effect level:

clinical signs

mortality

reproductive function (oestrous cycle)

reproductive function (sperm measures)

Key result

Critical effects observed:

no

Remarks on result:

other: no data provided

Remarks on result:

other: no data provided

Remarks on result:

other: no data provided

Key result

Reproductive effects observed:

no

Table 1: Results from key studies performed on the source substances of the category

Common name	CAS	Fatty acid chain length	Type of alcohol	MW	Appareance	Toxicity to reproduction –Fertility
Isopropyl myristate	110-27-0	C14	Isopropanol	270,46	Liquid	no data
Isopropyl palmitate	142-91-6	C16	Isopropanol	298.51	Liquid	no data
Ethyl linoleate	544-53-4	C18:2	ethanol	308,5	Liquid	no data
Ethyl oleate	111-62-6	C18:1	ethanol	310.52	Liquid	Experimental result: NOAEL: 5500 mg/kgbw/day
Fatty acids, C16-18, butyl esters	85408-76-0	C16-18	Butanol	312.53 – 340.58	Paste	no data
Fatty acids, C16-18 and C18-unsatured, isobutyl esters	84988-79-4	C16-18, C18:1	Isobutanol	312.53 – 340.58	Liquid	no data
Isopropyl isostearate	68171-33-5	C18iso	Isopropanol	326.56	Liquid	no data

 

All the category substances are fatty acid esters. After oral ingestion, it is expected that substances are hydrolyzed by pancreatic lipases. The degradation products are free fatty acids and free alcohol which could be distributed in organism through systemic circulation. They are expected to be metabolized in common energetic pathways or excreted and notbioaccumulableafter repeated administration.

One study was available forreprotoxicityassessment for the ethyloleate. Rats were exposed during 91 days and reproductive functions were analyzed. No adverse effect was observed. Hence, the NOAEL was defined to be higher than 5500 mg/kgbw/day. The result is consistent with expected low toxicity of the category substances.

Conclusions:

Based on the structural similarities between the substances and on the category approach, the NOAEL value for reprotoxicity as higher than 5500 mg/kg bw/day is validated for the category substances.

Executive summary:

According to the Regulation (EC) NO. 1907/2006, Annex XI, 1.5, A read-across category for short chain fatty acid was performed in order to provide informations on ethyl palmitate.

This category was based on common and shared physico-chemical and structural properties as:

-       common functional group,

-       common precursors and the likehood of common impurities as well as common breakdown products via biological processes, which are chemically structurally similar, and

-       constant pattern in the changing of the potency of the properties across the category.

The category substances are fatty acid esters covering chain length C8 to C18 satured or unsatured linked to alcohol including ethanol, isopropanol and (iso)butanol. These substances showed similar physico-chemical properties as very low solubility in water, not volatile, ready biodegradable and high log Kow. The substances are expected to have same toxicity behavior according to the common structural and physico-chemical similarities. Indeed, they are expected to be metabolized or excreted in same way when orally administered in organism.The available information are consistent with expected low toxicity of the category substance.

Effect on fertility: via oral route

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

NOAEL

5 500 mg/kg bw/day

Study duration:

subchronic

Species:

rat

Additional information

The category group covers alcohol linked with fatty acid chains unsatured and satured. This category includes monoconstituent chemicals and UVCB substances varying acid chain length (C14 to C18) and based on alcohol function type (including ethanol, butanol and isopropanol). This approach was performed in order to provide sufficient information for physicochemical, ecotoxicological and toxicological characterizations of the ethyl palmitate. Based on structural and physic-chemicals similarities, available experimental studies from source chemicals could be used for the target substance ethyl palmitate.

This category group includes:

-       Isopropyl myristate                                                 CAS 110-27-0

-       Isopropyl palmitate                                                 CAS 142-91-6

-       Ethyl linoleate                                                         CAS 544-35-4

-       Ethyl oleate                                                            CAS 111 -62-6

-       Fatty acids, C16 -18, butyl esters                          CAS 85408-76-0

-       Fatty acids, C16 -18 and C18-unsatured isobutyl esters              CAS 84988-79-4

-       Isopropyl isostearate                                                                     CAS 68171-33-5

-       Target substance : Ethyl palmitate                                                  CAS 628-97-7

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, environmental fate and ecotoxicity, 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)”. Therefore, the available experimental data were collected and evaluated according to Annex XI requirements.

One available relevant study was performed on the ethyl oleate to assess the potential reprotoxicity. The study was performed according 1993 FDA draft “Redbook II” guideline. Rats were exposed in diet at 1.8, 3.6 and 5.5 g/kg bw/day during 91 days. Signs of toxicity, reproductive functions were assessed on parental animals. No treatment related effects on reproductive capacity of the animals was observed. Hence, the NOAEL was defined to be higher than 5500 mg/kg bw/day. Based on the structural similarities between the substances and on the category approach, the NOAEL value is validated for the category substances.

Justification for classification or non-classification

Based on the available study, and on the category approach, the target substance was not considered as reprotoxic. Hence, the ethyl palmitate was not classified for reprotoxicity according to CLP criteria