4-methylpentan-2-one oxime

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

29 January 1990 - 12 February 1990

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Remarks:

Study performed similar to OECD guideline 404.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

4-methylpentan-2-one oxime

EC Number:

203-298-2

EC Name:

4-methylpentan-2-one oxime

Cas Number:

105-44-2

Molecular formula:

C6H13NO

IUPAC Name:

4-methylpentan-2-one oxime

Test material form:

liquid

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 37905-27-4
- Expiration date of the lot/batch: no data
- Purity test date: no data


STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: 65°F - 85°F, store in well ventilated area
- Stability under test conditions: assumed stable for length of testing program
- Solubility and stability of the test substance in the solvent/vehicle: not applicable, the test article was tested neat


TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: the test item was applied neat

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Horne Rabbitry, Kaysville, Utah
- Age at study initiation: no data (young Adult)
- Weight at study initiation: 2.0 - 3.0 kg
- Housing: Animals were housed separately from any other species, individually housed in stainless steel, wire mesh bottom cages
- Diet (e.g. ad libitum): Fresh certified rabbit feed was provided -ad libitum
- Water (e.g. ad libitum): Fresh potable water was provided -ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°F): 61 - 70°F
- Humidity (%): 40 - 60%
- Air changes (per hr): not less than 10 air changes per hour
- Photoperiod (hrs dark / hrs light): 12/12 hour, light/dark cycle

Test system

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent positive control

yes, concurrent negative control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL

NEGATIVE CONTROL
- Untreated

POSITIVE CONTROL
- Amount(s) applied (volume or weight): 0.5 mL
- Concentration: 1% w/v aqueous solution

Duration of treatment / exposure:

24 hours

Observation period:

14 days

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: (1 x 1 inch)
- Type of wrap if used: the test and control articles were applied to the skin with a gauze patch which was securely taped in place with hypoallergenic tape. The patches were covered with an occlusive dressing consisting of an impervious, non-reactive plastic material and securely taped in place.
- approximately 24 hours prior to dermal administration, the hair was clipped from the dorsal and lateral areas of the animals.


REMOVAL OF TEST SUBSTANCE
- After 24 hours of exposure, the animals were unwrapped and the skin wiped with an absorbant pad to remove any remaining test article.

OBSERVATION TIME POINTS
(indicate if minutes, hours or days)
- Mortality: twice daily on work days and at least once daily on all other days
- Clinical observations: at prescreen, approximately 25 hours after patch removal, 48 hours, 72 hours and days 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14
- Body weight: within 48 hours of receipt and prior to dosing

SCORING SYSTEM:
- according to Draize
- Method of calculation: The primarv dermal irritation index (PDII) was calculated by summing the mean erythema score and the mean edema score from only the 25-, 48- and 72-hour observations.The PDII was calculated for the test material site, the positive control site, the untreated site and/or the moistening material control site . The PDII was then classified as follows:
PDII - 0.0 non irritant
> 0.0 - 0.5 negligible irritant
> 0.5 - 2.0 mild irritant
> 2.0 - 5.0 moderate irritant
> 5.0 - 8.0 severe irritant

Maximum possible calculated PDII equals 8

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 25/48/72

Score:

4

Max. score:

4

Reversibility:

not fully reversible within: 14 days

Remarks:

desquamation at test site from Day 4 to 14

Remarks on result:

positive indication of irritation

Results 2

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: 25/48/72

Score:

2.3

Max. score:

4

Reversibility:

fully reversible within: 10 days

Remarks on result:

positive indication of irritation

Results 3

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: 24/48/72

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 8 days

Remarks:

desquamation at test site from Day 4 to 14

Remarks on result:

positive indication of irritation

Results 4

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: 25/48/72

Score:

1.3

Max. score:

4

Reversibility:

fully reversible within: 4 days

Remarks on result:

positive indication of irritation

Results 5

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 8 days

Remarks:

desquamation at the test site from Day 4 to Day 7

Remarks on result:

positive indication of irritation

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

no indication of irritation

Results 7

Irritation parameter:

erythema score

Basis:

animal #4

Time point:

24/48/72 h

Score:

1.6

Max. score:

4

Reversibility:

fully reversible within: 8 Days

Remarks on result:

positive indication of irritation

Results 8

Irritation parameter:

edema score

Basis:

animal #4

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 8 Days

Remarks on result:

positive indication of irritation

Results 9

Irritation parameter:

erythema score

Basis:

animal #5

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 8 Days

Remarks:

desquamation at the test site from Days 4 to 9

Remarks on result:

positive indication of irritation

Results 10

Irritation parameter:

edema score

Basis:

animal #5

Time point:

24/48/72 h

Score:

1.6

Max. score:

4

Reversibility:

fully reversible within: 5 days

Remarks on result:

positive indication of irritation

Results 11

Irritation parameter:

erythema score

Basis:

animal #6

Time point:

24/48/72 h

Score:

2.3

Max. score:

4

Reversibility:

fully reversible within: 8 Days

Remarks:

desquamation at the test site from Days 5 to 14

Remarks on result:

positive indication of irritation

Results 12

Irritation parameter:

edema score

Basis:

animal #6

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

not fully reversible within: 7 days

Remarks on result:

positive indication of irritation

Irritant / corrosive response data:

All of the animals were free of any dermal irritation at prescreen.
The untreated negative control sites remained free of any dermal irritation throughout the study period.
At the 25 hour scoring period, erythema and edema were exhibited at the test and positive control sites.
At the 48 hour scoring period, erythema and edema were exhibited at the test and positive control sites.
At the 72 hour scoring period, erythema and edema were exhibited at the test and positive control sites.
Dermal irritation was exhibited to some degree from day 4 to 14 at both the test and positive control sites. Desquamation was also noted at some of the test and positive control sites from day 4 to 14.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the average for the 25, 48 and 72 hour readings, the Primary Dermal Irritation Index was calculated to be 3.6; therefore, test article MIBKO was classified as a Moderate Irritant under the conditions of the test. Based on the criteria of the CLP regulation (EC) 1272/2008, the test item did not meet the criteria for classification.