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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
screening for reproductive / developmental toxicity
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Justification for type of information:
See "Assessment reports" section 13 or "Categories" section for the justification and rationale document for category approach.

Data source

Materials and methods

Test guideline
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).

Test material

Constituent 1
Chemical structure
Reference substance name:
Ethyl decanoate
EC Number:
203-761-9
EC Name:
Ethyl decanoate
Cas Number:
110-38-3
Molecular formula:
C12H24O2
IUPAC Name:
ethyl decanoate
Test material form:
liquid

Results and discussion

Results: P0 (first parental generation)

Effect levels (P0)

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)

Target system / organ toxicity (P0)

Key result
Critical effects observed:
no

Results: P1 (second parental generation)

Effect levels (P1)

Key result
Remarks on result:
not measured/tested

Results: F1 generation

Effect levels (F1)

Key result
Remarks on result:
not measured/tested

Overall reproductive toxicity

Key result
Reproductive effects observed:
no

Any other information on results incl. tables

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

Common name

CAS

Fatty acids chain length

 Type of  alcohol

MW

Appareance

Toxicityto
reproduction
Fertility

Ethyl decanoate

110-38-3

C10

ethanol

200.32

Liquid

No data

Ethyl undecylenate

692-86-4

C11

ethanol

212.33

liquid

No data

Isopropyl laurate

10233-13-3

C12

Isopropanol

242,41

Liquid

no data

Octyl octanoate

2306-88-9

C8

octanol(C8)

256,42

Liquid

no data

Isopropyl myristate

110-27-0

C14

Isopropanol

270,46

Liquid

no data

Dodecanoic hexyl ester

34316-64-8

C12

Hexanol(C6)

284,49

Liquid

no data

Ethyl linoleate

544-35-4

C18:2

ethanol

308,5

Liquid

no data

Ethyl oleate

111-62-6

C18:1

ethanol

310.52

Liquid

Experimental
result:
NOAEL:
5500 mg/kg
bw/day

2-ethylhexyl laurate

20292-08-4

C12

2-Ethyl-Hexanol

312,53

Liquid

no data

Fatty acids, coco, 2-ethylhexyl esters

92044-87-6

C12-14

2-ethylhexanol

312.53 –
340.60

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 not bioaccumulable after repeated administration.

One study was available for reprotoxicity assessment for ethyl oleate. 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.

 

 

Applicant's summary and conclusion

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 decanoate CAS 110-38-3.

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, octanol, hexanol and 2-ethylhexanol. 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.