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Diss Factsheets

Administrative data

Description of key information

A modified Draize procedure was used to test the potential to induce allergic contact dermatitis in guinea pigs. Ethyl amyl ketone (CAS 106-68-3) was found not sensitising.

This was also true for other ketones tested with the same procedure such as the further read-across substance 3 -heptanone (Ethyl butyl ketone). Based on these results for the read-across substances, 5 -methylheptan-3 -one is not considered as sensitising to the skin

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well documented study comparable to guideline; non GLP
Principles of method if other than guideline:
Skin sensitisation of Ethyl amyl ketone on 10 guinae pigs was tested using a modified Draize technique. A preliminary irritation test was conducted to determine the suitable concentrations for the sensitising test. Following the preliminary test, new experiments were performed with animals being treated by intradermal injection to induce senitisation. They were challenged 2 weeks after, both by intradermal injection and topical application. When no sensititzation was observed, the induction and challenge steps were repeated.
GLP compliance:
no
Remarks:
Study performed before the introduction of GLP
Type of study:
Draize test
Justification for non-LLNA method:
Available study performed in 1978 well documented comparable to guideline but non GLP
Species:
guinea pig
Strain:
Hartley
Sex:
male/female
Details on test animals and environmental conditions:
Inbred Hartley strain albino guinea pigs weighing about 450g and bred in own colony were used. They were housed in pairs of the same sex in wire mesh cages. They were fed pelleted guinea pig diet, cabbage, hay and water ad libitum.
Route:
intradermal
Concentration / amount:
Preliminary irritation test for injection challenge concentration (concentration inducing slight but perceptible irritation but no oedema, ICC) and application challenge concentration (highest concentration causing no irritation, ACC):
Intradermal: 0.1 ml aliquots of a range of concentrations
Topical: 0.1 ml aliquots of a range of concentrations
Sensitization test: total dose was administered on one occasion as 4 intradermal injections, each 2.5x the injection challenge concentration (ICC).
Route:
intradermal and epicutaneous
Concentration / amount:
Preliminary irritation test for injection challenge concentration (concentration inducing slight but perceptible irritation but no oedema, ICC) and application challenge concentration (highest concentration causing no irritation, ACC):
Intradermal: 0.1 ml aliquots of a range of concentrations
Topical: 0.1 ml aliquots of a range of concentrations
Sensitization test: total dose was administered on one occasion as 4 intradermal injections, each 2.5x the injection challenge concentration (ICC).
No. of animals per dose:
Preliminary irritation test: 4 animals of same sex
Sensitization test: 10 animals in each test, 4 males and 6 females or vice versa.
Details on study design:
Modified from Draize. 10 guinea pigs at about 350 g (at the start of the experiment) were used. 0.1 ml aliquots of the test item at 2.5 times the injection challenge concentration (ICC) were injected at 4 sites. Each animal was challenged intradermally in one flank and topically in the other with 0.1 ml aliqouts of test substance at ethe respective injection challenge concentration (ICC) and applicable challenge concentration (ACC) 14 days later. The reactions were scored 24 h after and apparent sensitization reactions were confirmed 7 days later by a second challenge with controls.
Challenge controls:
4 previoulsy untreated animals of the same sex and similar weight were treated intradermally and topically with 0.1 ml aliquots of the test substance at the injection challenge concentration (ICC) and applicable challenge concentration (ACC), respectively.
Positive control substance(s):
not specified
Reading:
rechallenge
Hours after challenge:
192
Group:
test chemical
Dose level:
0.2% (injection) and 20% (application)
Clinical observations:
none compared to controls
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 192.0. Group: test group. Dose level: 0.2% (injection) and 20% (application). Clinical observations: none compared to controls.

Injection challenge concentration ICC (%): 0.2

Applicable challenge concentration ACC (%): 20

Result: non-sensitizer (= no evidence of sensitization using the test procedure described)

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: other: as described above
Conclusions:
Ethyl amyl ketone (3-Octanone, CASNr: 106-68-3) is not sensitising.
Executive summary:

A modified Draize procedure was used to test the potential to induce allergic contact dermatitis in guinea pigs. Ethyl amyl ketone (3-Octanone, CASNr: 106-68-3) was found not sensitising.

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

A modified Draize procedure was used to test the potential to induce allergic contact dermatitis in guinea pigs. Ethyl amyl ketone (CAS 106-68-3) was found not sensitising. This was also true for other ketones tested with the same procedure such as the further read-across substance 3 -heptanone (Ethyl butyl ketone). Based on these results for the read-across substances, 5 -methylheptan-3 -one is not considered as sensitising to the skin.


Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification