Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation
Remarks:
in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
no data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Study conducted prior to introduction of Good Laboratory Practices; data from a summary report; insufficient experimental detail; actual test report not available for review. Study was conducted by an internal Eastman Kodak Company method, developed prior to established guidelines.
Qualifier:
no guideline available
Deviations:
not specified
Principles of method if other than guideline:
Not specified; method used is most like the Open Epicutaneous Test in which the test substance is repeatedly applied topically, and subsequently evaluated for any increase in the dermal reaction elicited.
GLP compliance:
no
Type of study:
other: Study conducted according to an internal Eastman Kodak Company laboratory method, not used elsewhere.
Species:
guinea pig
Strain:
Hartley
Sex:
not specified
Details on test animals and environmental conditions:
no data
Route:
other: Not specified; most likely open epicutaneous
Vehicle:
no data
Concentration / amount:
no data
Route:
other: Not specified; most likely open epicutaneous
Vehicle:
no data
Concentration / amount:
no data
No. of animals per dose:
5 animals in test group (sex not reported)
Details on study design:
no data
Challenge controls:
no data
Positive control substance(s):
not specified
Reading:
1st reading
Group:
test group
Dose level:
no data
No. with + reactions:
1
Total no. in group:
5
Clinical observations:
A weak allergic response was observed in one of five guinea pigs.
Remarks on result:
other: Reading: 1st reading. Group: test group. Dose level: no data. No with. + reactions: 1.0. Total no. in groups: 5.0. Clinical observations: A weak allergic response was observed in one of five guinea pigs..
Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
One of five guinea pigs displayed a weak allergic response following a presumed open epicutaneous exposure to methyl isoamyl ketone. No sensitization responses were observed in the four remaining animals. Based on the results of this study, methyl isoamyl ketone is not expected to be classified for sensitization by skin contact under GHS.
Executive summary:

In a skin sensitization study using an Eastman Kodak Company study design, five guinea pigs were induced and challenged by presumed open epicutaneous exposure to methyl isoamyl ketone. Skin examinations after the challenge dose indicated no positive sensitization reactions were evident in four of the five animals. Only a weak allergic response was reported in the remaining animal after the challenge application. Based on results of this study, methyl isoamyl ketone is not considered to be a skin sensitizer in guinea pigs, and therefore, presents a low skin sensitization hazard upon skin contact under conditions of normal use.

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

The potential for methyl isoamyl ketone to cause dermal sensitization was evaluated using a non-guideline study in which guinea pigs were repeatedly exposed to the test material using an open epicutaneous method. One of five animals displayed a weak allergic response while the four remaining animals exhibited no response. In addition, guinea pigs receiving 7 applications of the test material over a 10-day period in a repeated skin irritation study showed no evidence of a sensitization response. Slight to moderate erythema in 2 of 5 animals and dry skin with cracked eschars in all animals in this study were more likely due to the drying effects of repeated solvent exposure than to a sensitization response.

Justification for classification or non-classification

No evidence of a sensitization response was observed when guinea pigs were exposed to the test material in a dermal sensitization study or a repeat-exposure dermal irritation study. Based on a weight-of-the-evidence assessment, methyl isoamyl ketone is not classified for “Skin Sensitization” according to GHS guidelines.