Registration Dossier

Administrative data

Description of key information

The substance is not skin sensitising.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Justification for type of information:
Please consult the Read-Across Justification Document in section 13 of IUCLID.
Reason / purpose:
read-across source
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
100, 30, 10 and 3 %
No. with + reactions:
0
Total no. in group:
6
Reading:
2nd reading
Hours after challenge:
24
Group:
test group
Dose level:
100, 30, 10 and 3 %
No. with + reactions:
0
Total no. in group:
6
Interpretation of results:
GHS criteria not met
Conclusions:
Read across was done from nonyl acetate. Nonyl acetate was not skin sensitising.
Executive summary:

Read-across is done from nonyl acetate. An open epicutaneous test (OET) was conducted on guinea pigs to determine the capacity of nonyl acetate to induce allergenic sensitization. Four test groups of 6 animals and a control group were included in the study. During the induction phase 100, 30, 10, and 3% of nonyl acetate in ethanol was applied to the clipped flank of each animal and left uncovered. The applications were repeated daily for 21 consecutive days. Skin irritation was evaluated at 7, 14 and 21 days. Challenge application was performed on days 21 and 35 on the contralateral flank. The minimal irritation concentration (10%) and 3% were used and left uncovered. Reactions were read after 24, 48 and 72 hours after application. The test material is considered allergenic at a concentration when at least 1 out of 6 animals of the concentration group shows positive reactions with non-irritant concentrations used for challenge

No positive reactions were observed at any concentration, not after induction and not after the first or the second challenge. Therefore, nonyl acetate is considered not skin sensitizing in guinea pigs.

Based on this result, and on the structural, chemical and toxicological similarities between nonyl and decyl acetate, it can be concluded that decyl acetate is not skin sensitizing.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

For this endpoint there are 3 studies available. Two studies investigate the sensitising potential of the read-across substance nonyl acetate (1980 a and b) in guinea pigs and the third study (1974) assessed the skin sensitising potential of decyl acetate in humans.

In the first study (1980 a) an open epicutaneous test was conducted on guinea pigs with nonyl acetate using 100, 30, 10, and 3% in ethanol. The test item was left uncovered. The applications were repeated for 21 days and challenge was done on days 21 and 35 with 10% and lower concentrations and left uncovered. Reactions were read after 24, 48 and 72 hours later. No positive reactions were observed at any concentration, therefore, the test material is considered not skin sensitizing in guinea pigs.

In the second study (1980 b) an intradermal test with Freund's Complete Adjuvant (FCA) was conducted with guinea pigs. Induction was done with 5 intradermal injections of nonyl acetate mixed with FCA into the neck on days 0, 2, 4, 7 and 9. The challenge was on days 21 and 35, and reactions were read after 24, 48 and 72 hours. No effects were observed, and therefore it can be stated that the nonyl acetate has no sensitizing potential.

In the third study (1974) a maximization study was done with 25 human volunteers with 8% of decyl acetate in petrolatum. (See section 7.10.4 in IUCLID.) The occlusive patch tests were placed on forearm of the subjects 5 alternate days for 48 hours with a 24 hour rest period between removal and re-application of the patch. After a 2 week rest period challenge was done by a 48-hour occluded patch with the maximum non-irritating concentration. The challenge site was scored 24 and 48 hours after patch removal and the sensitisation index is noted. No reactions were observed.

Taking together all available information on the source substance nonyl acetate and the target substance decyl acetate, it can be concluded that decyl acetate is not skin sensitizing.

Justification for classification or non-classification

Skin sensitisation

The substance did not provoke any skin sensitisation effects in 3 different studies. According to the Tables 3.4.3 and 3.4.4 of the CLP Regualtion No 1272/2008 the substance is not to be classified as skin sensitiser.