undecan-2-one; methyl nonyl ketone

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

4-04-2002 to 18-04-2002

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

Data is with registered substance.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2003

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Undecan-2-one

EC Number:

203-937-5

EC Name:

Undecan-2-one

Cas Number:

112-12-9

Molecular formula:

C11H22O

IUPAC Name:

undecan-2-one

Test material form:

liquid

Details on test material:

SOURCE OF TEST MATERIAL
- batch No.of test material: 05500109421007
- 07 November 2001
- Storage conditions room temperature in the dark
- clear colourless liquid

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- batch No.of test material: 05500109421007
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperatt,rre in the dark
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: test material was used as supplied
OTHER SPECIFICS: clear colourless liquid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: David Percival Ltd, Moston, Sandbach, Cheshire, UK.
- Age at study initiation: twelve to sixteen weeks old
- Weight at study initiation: 2.0 to 3.5 kg
- Housing: individually housed in suspended metal cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

not specified

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit):0.5 ml
- Concentration (if solution): undiluted
VEHICLE
- No vehicle
NEGATIVE CONTROL
- Not applicable
POSITIVE CONTROL
- Not applicable

Duration of treatment / exposure:

The cotton gauze patch was removed after 4 hours.

Observation period:

14 days

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: the back of each rabbit
- % coverage: the patch is 2.5 by 2.5 cm in size
- Type of wrap if used: cotton gauze
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes, with cotton wool soaked in 74% Industrial Methylated Spirits
- Time after start of exposure: 4 hours
OBSERVATION TIME POINTS
one hour, 24, 48 and 72 hours after removal of the patches
SCORING SYSTEM:
- Method of calculation:The scores for erythema and oedema at the 24- and 72- hour readings were totalled for the three test rabbits (12 values) and this total was divided by six to give the primary irritation index of the study material.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

fully reversible within: 14 days After 7 days crust formation

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

fully reversible within: 14 days

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

fully reversible within: 14 days After 7 days there was crust formation observed

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

fully reversible within: 7 days

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24 h

Score:

2

Results 6

Irritation parameter:

edema score

Basis:

animal #2

Time point:

48 h

Score:

3

Results 7

Irritation parameter:

edema score

Basis:

animal #2

Time point:

72 h

Score:

2

Reversibility:

fully reversible within: 14 days

Results 8

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

fully reversible within: 7 days

Irritant / corrosive response data:

Erythema: Well defined erythema was noted for all animals within the first 72 hours following removal of the patch. Crust formation was observed after 7 days. The effects were fully reversible after 14 days.
Oedema: Slight oedema was noted for all animals within the first 72 hours following removal of the patch. Adverse reactions prevented the evaluation after 7 days for test animal #93, but the effects for testanimal #91 and #94 were fully reversible after 14 days.

Applicant's summary and conclusion

Interpretation of results:

other: Category 2 irritant Annex I of the CLP Regulation (1272/2008/EC)

Conclusions:

Based on the results in this study the compound needs to be classified as a category 2 irritant in accordance with the criteria outlined in Annex I of the CLP Regulation (1272/2008/EC).

Executive summary:

An acute dermal irritation study was conducted, according to OECD GL 404, on 3 male New Zealand White rabbits using the test material Methyl Nonyl Ketone. 0.5 ml of the test material was applied under semi-occlusion to the clipped backs of the 3 rabbits. The patch was removed after 4 hours. Observations for dermal irritation or defects were made at 1, 24, 48 and 72 hours after patch removal, and after 7 and 14 days. A single 4-hour, semi-occluded application of the test material to the intact skin of three rabbits produced well-defined erythema and slight to moderate oedema. Crust formation was noted at all treated skin sites at the 7-day observation. All treated skin sites appeared normal at the 14-day observation. The test material produced a primary irritation index of 4.0 and was classified as a moderate irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted. Based on these results Methyl Nonyl Ketone needs to be classified as a category 2 irritant in accordance with the criteria outlined in Annex I of the CLP Regulation (1272/2008/EC).