2-ethylhexyl acetate

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

Only basic data were given for a human maximization test, which however are reliable for the assessment of the skin sensitization potential of 2-EHAc. The test substance, applied as 4% solution in petrolatum, did not produce sensitisation in 29 tested volunteers (Opdyke 1979 and Epstein 1976).

Additionally, 2-EHAc was tested as 1% and 0.5% dilution in two patch tests with 7 and 5 occupationally exposed volunteers (dentist staff), respectively. In both tests, 2-EHAc caused no effects (Estlander et al. 1984; Kanerva et al. 1989).

In addition, the sensitizing potential of 2-EHAc was evaluated using OASIS TIMES MIX V.2.26.4 (2010). The program came to the conclusion that 2 -EHAc is not a skin sensitizer. The substance was in domain of the system.

An additional QSAR was performed with the latest version of OASIS TIMES 2.27.12 TB (2013). Again, the program concluded that 2 -EHAc is not a skin sensitier. The substance was in domain of the system, a QMRF and QPRF is provided attached to the study record.

Read-across from supporting substance (structural analogue or surrogate) 3,5,5 -Trimethylhexyl acetate:

A maximization test (Kligman, 1966) was carried out on 25 volunteers. 3,5,5 -Trimethylhexyl acetate was tested at a concentration of 4% in petrolatum and produced one sensitization reaction among the 25 subjects tested (Kligman, 1973) (RIFM no. 72-4-231). In a second maximization test (Kligman, 1966), carried out on 24 volunteers, 3,5,5 -Trimethylhexyl acetate was tested at a concentration of 4% in petrolatum and produced no sensitization reactions (Epstein, 1973) (RIFM no. 73-4-62). An additional maximization test was carried out on 26 volunteers, using a concentration of 4% 3,5,5 -Trimethylhexyl acetate in petrolatum, and did not produce any sensitization reactions (Epstein, 1974).

3,5,5 -Trimethylhexyl acetate was tested in a modified Draize sensitization test in guinea pigs (Sharp DW, 1978). Ten guinea pigs, about 350 g at the start of testing, were used in the test. For each animal 0.1 ml aliquots of test substance at 2.5 times the ICC (0.5 %) were injected intradermally at 4 sites which overlie the 2 auxillary and 2 inguinal lymph nodes. Fourteen days later each animal was challenged intradermally in one flank and topically in the other with 0.1 ml aliquots of test substance at the respective ICC (0.2 %) and ACC (20 %): the topical application was made by spreading 0.1 ml of the test substance onto the shaved flank in a small circular area which was not covered. Twenty-four hours later the reactions were scored and apparent sensitization reactions confirmed 7 days later by a second challenge with controls included. In the absence of sensitization reactions at first challenge the induction and challenge procedures were repeated, but this time a comfirmatory challenge with controls was included irrespective of any apparent sensitization reactions at the previous challenge. None of the 10 guinea pigs treated with 3,5,5 -Trimethylhexyl acetate gave a positive reation in this skin sensitization test. 3,5,5 -Trimethylhexyl acetate was therefore judged as non-senitizer.

Read-across from supporting substance (structural analogue or surrogate) Hexyl acetate:

Klecak (Klecak G, 1985) examined the skin sensitization potential of hexyl acetate in the open epicutaneous test in guinea pigs and in humans in either the maximization test or the repeat insult patch test (test concentration in humans: 4 %). Hexyl acetate was not a skin sensitizer in guinea pigs and also not in humans.

Read-across from supporting substance (structural analogue or surrogate) Heptyl acetate:

Klecak (Klecak G, 1985) examined the skin sensitization potential of heptyl acetate in the open epicutaneous test in guinea pigs and in humans in either the maximization test or the repeat insult patch test (test concentration in humans: 2 %). Heptyl acetate was not a skin sensitizer in guinea pigs and also not in humans.

Read-across from supporting substance (structural analogue or surrogate) Octyl acetate:

Klecak (Klecak G, 1985) examined the skin sensitization potential of octyl acetate in the open epicutaneous test in guinea pigs and in humans in either the maximization test or the repeat insult patch test (test concentration in humans: 8 %). Octyl acetate was not a skin sensitizer in guinea pigs and also not in humans.

Read-across from supporting substance (structural analogue or surrogate) Nonyl acetate:

Klecak (Klecak G, 1985) examined the skin sensitization potential of nonyl acetate in the open epicutaneous test in guinea pigs and in humans in either the maximization test or the repeat insult patch test (test concentration in humans: 2 %). Nonyl acetate was not a skin sensitizer in guinea pigs and also not in humans.

Read-across from supporting substance (structural analogue or surrogate) 2 -ethylhexan-1 -ol:

Only basic data were given for a human maximization test, which however are reliable for the assessment of the kin sensitization potential. The test substance, 2 -ethylhexan-1 -ol, applied as 4% solution in petrolatum, did not produce a sensitization reaction in 29 tested volunteers (Opdyke 1979 and Epstein 1976).

Read across justification:

3,5,5 -Trimethylhexyl acetate is an ester of 3,5,5 -Trimethylhexan-1 -ol and Acetic acid and differs from 2 -ethylhexyl acetate (ester of 2 -ethylhexan-1 -ol and acetic acid) by only one CH2 -Group (C11H22O2 vs. C10H20O2) if looking at the molecular formula which makes both substances close structural analogues and therefore suitable for read across concerning skin sensitization, as both substances are esters of acetic acid and an alcohol.

Hexyl acetate is an ester of Hexan-1 -ol and Acetic acid and differs from 2 -ethylhexyl acetate (ester of 2 -ethylhexan-1 -ol and acetic acid) by only two CH2 -Groups (C8H16O2 vs. C10H20O2) if looking at the molecular formula which makes both substances close structural analogues and therefore suitable for read across skin sensitization, as both substances are esters of acetic acid and an alcohol.

Heptyl acetate is an ester of Heptan-1 -ol and Acetic acid and differs from 2 -ethylhexyl acetate (ester of 2 -ethylhexan-1 -ol and acetic acid) by only one CH2 -Groups (C9H18O2 vs. C10H20O2) if looking at the molecular formula which makes both substances close structural analogues and therefore suitable for read across skin sensitization, as both substances are esters of acetic acid and an alcohol.

Octyl acetate is an ester of Octan-1 -ol and Acetic acid and differs from 2 -ethylhexyl acetate (ester of 2 -ethylhexan-1 -ol and acetic acid) only structurally, the molecular formular is identical (C10H20O2) which makes both substances close structural analogues and therefore suitable for read across skin sensitization, as both substances are esters of acetic acid and an C8 -alcohol.

Nonyl acetate is an ester of Nonan-1 -ol and Acetic acid and differs from 2 -ethylhexyl acetate (ester of 2 -ethylhexan-1 -ol and acetic acid) by only by one CH2 -Groups (C11H22O2 vs. C10H20O2) if looking at the molecular formula which makes both substances close structural analogues and therefore suitable for read across skin sensitization, as both substances are esters of acetic acid and an alcohol.

2 -EHAc is rapidly cleaved in the body by Carboxylesterases into 2 -ethylhexan-1 -ol and acetic acid. 2 -ethylhexan-1 -ol is therefore suitable to assess the skin senitization potential of 2 -ethylhexyl acetate.

Migrated from Short description of key information:
Human maximazation test: not sensitising (Epstein 1976)
Human patch test: 1% in petrolatum: not sensitising in 7 subjects (Estlander 1984)
0.5%: not sensitising in 5 subjects (Kanerva 1989)
QSAR: Not a skin sensitizer (Val. 2)

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

According to the results of the available tests, the test substance has not to be classified as skin sensitiser following 67/548/EEC and GHS requirements, respectively.