5-methylheptan-3-one oxime

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

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

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

not specified

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

5-methylheptan-3-one oxime

EC Number:

245-010-8

EC Name:

5-methylheptan-3-one oxime

Cas Number:

22457-23-4

Molecular formula:

C8H17NO

IUPAC Name:

5-methylheptan-3-one oxime

impurity 1

Reference substance name:

(E)-3,4-dimethylhexan-2-one oxime

IUPAC Name:

(E)-3,4-dimethylhexan-2-one oxime

impurity 2

Reference substance name:

(Z)-3,4-dimethylhexan-2-one oxime

IUPAC Name:

(Z)-3,4-dimethylhexan-2-one oxime

Test material form:

liquid

Test animals

Species:

guinea pig

Strain:

not specified

Test system

Type of coverage:

open

Preparation of test site:

clipped

Vehicle:

other: 10% ethanol

Controls:

yes

Amount / concentration applied:

concentrations of 30, 10, 3 and 1%

Duration of treatment / exposure:

There are 2 parts to this test, a single application and a 21-Day repeated application test.

Observation period:

In the single applicaiton test, thre was an observation period of 24 hours
In the repeated dos group, observations were recorded on days 7, 14 and 21

Number of animals:

6-8 animals were used in the single application test.
6 animals per dose (24 total) were used in the repeated application test

Details on study design:

Under the current OECD guidance, the repeated dose application test can not be used to assess clarification, only to aid irritant levels if a single application is only observed for 24 hours.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

other: Irritation

Basis:

other: 100% concentration

Time point:

24 h

Score:

1

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

other: Slight Skin Irritation

Results 2

Irritation parameter:

other: Irritation

Basis:

other: 30% concentration

Time point:

24 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

other: Slight Skin Irritation

Any other information on results incl. tables

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.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

After a single application, slight irritation was observed at a concentration of 100%.
Although no observations were taken at 48 and 72 hours, the data from the repeated dose study at 7, 14 and 21 days indicates that only slight irritation was observed.
Therefore, after a single application, no additional irritation would be expected which would lead to classification.

Executive summary:

Slight irritation observed after a single application which is insufficient for classification purposes.

This non-classification is based on the additional information after 21 days repeated dosing at 3%, 10%, 30% and 100% where after 7 days dosing at 100%, only slight irritation was observed.

Therefore after a single dose, it is extremely unlikely that oxyoctaline formate would be an irritant after 7 days and therefore would not be classifiable.