Registration Dossier

Administrative data

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.

Data source

Reference
Reference Type:
other: Eastman Kodak Company Basic Toxicity Summary Report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Test guideline
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.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Details on test material:
-Name of test material as cited in study report: Methyl isoamyl ketone
-Appearance: liquid
-Melting Point: -74 °C
-Boiling Point: 145 °C at 760 mm Hg
-Solubility: 0.5% in water at 20 °C
-Purity: 98%
-Impurities: 2% MIBK, 10-20 ppm HOMME
-Shipped to testing laboratory: May 16, 1978
-Source of test material: Tennesse Eastman Company (Eastman Chemical Company)
-Storage conditions: room temperature and humidity

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
not specified
Details on test animals and environmental conditions:
no data

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
other: Not specified; most likely open epicutaneous
Vehicle:
no data
Concentration / amount:
no data
Challengeopen allclose all
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

Results and discussion

In vivo (non-LLNA)

Results
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..

Applicant's summary and conclusion

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.