Fatty acids, C14-18 and C18-unsatd., branched and linear, 2-ethylhexyl esters

Developmental toxicity / teratogenicity

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Administrative data

Endpoint:

developmental toxicity

Type of information:

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

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Materials and methods

Test material

Test material information

Constituent 1

Test material form:

liquid

Results and discussion

Results: maternal animals

Effect levels (maternal animals)

Key result

Dose descriptor:

NOAEL

Effect level:

1 000 mg/kg bw/day (nominal)

Based on:

test mat.

Basis for effect level:

other: Available study for read across category

Maternal abnormalities

Abnormalities:

no effects observed

Results (fetuses)

Effect levels (fetuses)

Key result

Dose descriptor:

NOAEL

Effect level:

1 000 mg/kg bw/day (nominal)

Based on:

test mat.

Sex:

male/female

Basis for effect level:

other: Basedon available study for read across category approach

Fetal abnormalities

Abnormalities:

no effects observed

Overall developmental toxicity

Developmental effects observed:

no

Any other information on results incl. tables

Table 1: Results from key studies on source chemicals of the category for teratogenicity tests.

ID#	CAS	Toxicity to reproduction – Developmental Toxicity
Fatty acids, C8-16, 2- ethylhexylesters	135800-37-2	No data
Fatty acids, coco, 2-ethylhexyl esters	92044-87-6	No data
2-Ethylhexyl palmitate	29806-73-3	No data
Fatty acids, C16-18 and C18-unsatd., 2- ethylhexylesters	85049-37-2	No data
Fatty acids, C16-18, 2-ethylhexyl esters	91031-48-0	NOAEL 1000 mg/kgbw/day
2-Ethylhexyl oleate	26399-02-0	No data
2-Ethylhexyl stearate	22047-49-0	NOAEL: 1000 mg/kgbw/day

 

Similar toxicokinetic behavior and toxicity profile

All category members are subject to enzymatic hydrolysis by pancreatic lipases resulting in free acids and alcohol. Based on current literature, when absorbed from intestines and carried through blood stream, fatty acids are oxidized by beta-oxydationpathway in order to provide energy for cell and stored as glycerides esters in fat deposit. The alcohols are primarily metabolized in the liver.

 

Hence, it can be stated that the members of the category have the same toxicity due to the same metabolic pathways when absorbed in the organisms.

 

Two studies for the developmental toxicity were available within the LCAE C8 to C18, for the category members 2-ethylhexyl stearate and Fatty acids, C16-18 2-ethylhexyl esters. (OECD 414 method for Teratogenicity test performed in rat). They did not show treatment related effects up to the highest tested dose level. Thus, no hazard for developmental toxicity was identified. The NOAEL forembryotoxicityandmaternotoxicitywas defined at 1000 mg/kgbw/day.

 

According to the results of the available studies for LCAE Category members, the NOAEL for materno- and embryo- toxicity was defined at 1000 mg/kgbw/day. According to the CLP criteria and the Category Members results, the registered substance was not classified for teratogenicity.

 

Applicant's summary and conclusion

Conclusions:

According to the results of the available studies for LCAE Category members, the NOAEL for materno and embryotoxicitywas defined at 1000 mg/kgbw/day. According to the CLP criteria and the Category Members results, the registered substance was not classified for teratogenicity.