5-methylheptan-3-one oxime

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Reference 1

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Deviations:

not specified

GLP compliance:

not specified

Type of study:

guinea pig maximisation test

Justification for non-LLNA method:

LLNA not available at time of testing.

Species:

guinea pig

Strain:

not specified

Sex:

not specified

Route:

epicutaneous, open

Vehicle:

other: 10% Ethanol

Concentration / amount:

100, 30, 10, 3% in 10% ethanol

Route:

epicutaneous, open

Vehicle:

other: 10% Ethanol

Concentration / amount:

100, 30, 10, 3% in 10% ethanol

No. of animals per dose:

6

Positive control substance(s):

not specified

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

5

No. with + reactions:

0

Total no. in group:

10

Remarks on result:

no indication of skin sensitisation

Reading:

2nd reading

Hours after challenge:

48

Group:

test chemical

Dose level:

5

No. with + reactions:

0

Total no. in group:

10

Remarks on result:

no indication of skin sensitisation

Reading:

other: 3rd reading

Hours after challenge:

72

Group:

test chemical

Dose level:

5

No. with + reactions:

0

Total no. in group:

10

Remarks on result:

no indication of skin sensitisation

Single application test

Slovent: ethanol

Lowest irritant concentration = 100%

Highest non irritant concentration = 30%

Repeated applications over 21 successive days

Concentration %	Skin irritation after days
	7	14	21
100	(+)	(+)	+
30	-	(+)	(+)
10	-	-	-
3	-	-	-

Degree of skin irritation:

–= none

+= slight

++= moderate

+++= strong

Capacity to induce allergic sensitization

After daily applications over three weeks Concentration in %	Sensitisation rate Number of animals Positive/Total
	Day 21	Day 35
100	0/6	0/6
30	0/6	0/6
10	0/6	0/6
3	0/6	0/6

Results:

STEMONE is a well-tolerated preparation. The highest non-irritant solution after single application is 30%,after repeated applications 10% in ethanol. The 30% solution causes only very slight skin irritation beginning after one week's treatment. No sensitization occurs with STEMONE in the guinea pig under conditions of the OET.

Interpretation of results:

GHS criteria not met

Conclusions:

No sensitization occurs with STEMONE in the guinea pig under conditions of the OET.

Executive summary:

Open Epicutaneous Test

Test Material is applied epicutaneously, uncovered, undiluted, and if possible and relevant, dissolved in concentrations of 30, 10, 3% in ethanol. Constant volumina of each concentration are applied with a pipette on standard areas of the clipped flank of each animal.

STEMONE is a well-tolerated preparation. The highest non-irritant solution after single application is 30%,after repeated applications 10% in ethanol. The 30% solution causes only very slight skin irritation beginning after one week's treatment. No sensitization occurs with STEMONE in the guinea pig under conditions of the OET.

Reference 2

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Abstract only

Qualifier:

according to guideline

Guideline:

other: The technique employed in this study was that of the repeated insult method approyed "by the Food and Drug Administration.

Deviations:

not specified

Principles of method if other than guideline:

The technique employed in this study was that of the repeated insult method approved by the "Food and Drug Administration".

GLP compliance:

no

Type of study:

patch test

Justification for non-LLNA method:

LLNA not available at time of testing.

Species:

human

Strain:

not specified

Sex:

male/female

Details on test animals and environmental conditions:

The fifty-seven subjects were selected on a random basis in the order of their applying for participation in this study, except that no person was accepted who had active dermatologic conditions or other indicated illnesses. Previous sensitivities or a history of allergy were not considered to be reasons for rejection.
Out of the 57 volunteers who started this study, 53 completed all of the sensitivity tests and the challenge test series. The minimal loss of personnel in this full study resulted from personal reasons (two subjects developed upper respiratory infections during the study; one had a change in working hours and was unable to attend the tests; and one found it personally inconvenient).
Out of the 53 individuals who completed all of the tests, 50 were female and 3 male. Forty-seven of these subjects were between 18 and 32 years of age with the remaining six individuals being between 35 and 52 years of age.
The preponderance of female subjects increased the potentialities for sensitization and irritation responses.

Reading:

1st reading

Hours after challenge:

48

Group:

test chemical

Dose level:

2

No. with + reactions:

0

Total no. in group:

53

Remarks on result:

no indication of skin sensitisation

Reading:

2nd reading

Hours after challenge:

72

Group:

test chemical

Dose level:

2

No. with + reactions:

0

Total no. in group:

53

Remarks on result:

no indication of skin sensitisation

The study was conducted according to the schedule and procedures as discussed in the preceding section of this report. There were no complications and no alterations in the planned procedure were necessary.

Out of the 57 volunteers who started this study, 53 completed all of the sensitivity tests and the challenge test series. The minimal loss of personnel in this full study resulted from personal reasons (two subjects developed upper respiratory infections during the study; one had a change in working hours and was unable to attend the tests; and one found it personally inconvenient).

Out of the 53 individuals who completed all of the tests, 50 were female and 3 male. Forty-seven of these subjects were between 18 and 32 years of age with the remaining six individuals being between 35 and 52 years of age.

The preponderance of female subjects increased the potentialities for sensitization and irritation responses.

There were no reactions either irritative or allergenic at any time either during the sensitization series or as a result of the challenge tests.

Because of the large number of tests which were applied and the necessary adhesive materials to keep these tests in place, there were at different times twenty-two reactions of irritation to the adhesive tape. In four of these subjects the reactions were becoming discomforting toward the end of the sensitization series. In the remainder of the individuals who reacted to the tape, the responses were primarily redness and puffiness which had disappeared by the time it was necessary to repeat the tests in the same sites.

Interpretation of results:

not sensitising

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Fifty-seven volunteers were inducted into this sensitization and challenge test study in accordance with the schedule and technique described in the Procedure. Fifty-three of these subjects completed the entire test series.
There were no reactions either irritative or allergenic to any of the preparations employed in this study.

Executive summary:

An investigation was conducted to ascertain the irritative and sensitizing potentialities of the titled seven coded preparations. Preparation DCIC was prepared in a 5% concentration, while the remaining six preparations were in 2% concentrations using dimethyl phthalate as the solvent.

Fifty-seven volunteers were inducted into this sensitization and challenge test study in accordance with the schedule and technique described in the Procedure. Fifty-three of these subjects completed the entire test series.

There were no reactions either irritative or allergenic to any of the preparations employed in this study.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

In several sensitisation studies, no sensitisation was observed.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Based on the negative results of several studies, the material can be considered not sensitising for CLP.