Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

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
Remarks:
according to GLP, including certificate

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report Date:
2003

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 14 days
Remarks:
After 7 days crust formation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 14 days
Remarks:
After 7 days there was crust formation observed
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24 h
Score:
2
Irritation parameter:
edema score
Basis:
animal #2
Time point:
48 h
Score:
3
Irritation parameter:
edema score
Basis:
animal #2
Time point:
72 h
Score:
2
Reversibility:
fully reversible within: 14 days
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
Remarks:
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).