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Administrative data

Description of key information

Skin irritation (OECD 404): category 2 skin irritant

Eye irritation (OECD405): not irritant

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
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
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)
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
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
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.
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.
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).

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
14 March 2001- 09 July 2002
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
Adopted 24 February 1987
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)
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 temperature 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
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: David Percival Ltd, Moston, Sandbach, Cheshire, UK.
- Age at study initiation: twelve to twenty weeks old
- Weight at study initiation: 2.0 to 3.5 kg
- Housing: The animals were individually housed in suspended metal cages.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23°C
- Humidity (%): 30 to 70%
- Air changes (per hr): fifteen changes per hour
- Photoperiod (hrs dark / hrs light): twelve hours continuous light (06:00 to 18:00) and twelve hours darkness.

Vehicle:
unchanged (no vehicle)
Controls:
other: The left eye remained untreated and was used for control purposes
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml

Duration of treatment / exposure:
The upper and lower eyelids were held together for about one second immediately after application of the material, to prevent loss of the test material, and then released. The eye was not rinsed.
Observation period (in vivo):
1 hour and 24, 48 and 72 hours
Number of animals or in vitro replicates:
3
Details on study design:
SCORING SYSTEM:

Draize Scale for Scoring Ocular Irritation according to:
Draize J H (1977) "Dermal and Eye Toxicity Tests" In: Principles and Procedures for Evaluating the Toxicity of Household Substances, National Academy of Sciences, Washington DC p.48 to 49

TOOL USED TO ASSESS SCORE: light source from a standard ophthalmoscope.
Irritation parameter:
cornea opacity score
Basis:
animal: 1, 2, 3
Time point:
other: 1/24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal: 1, 2, 3
Time point:
other: 1/24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal: 1, 2, 3
Time point:
other: 1h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal: 1, 2, 3
Time point:
24 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal: 1, 2, 3
Time point:
other: 48/72 h
Score:
0
Max. score:
3
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
Discharge
Basis:
animal: 1, 2, 3
Time point:
other: 1h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Remarks:
Discharge
Basis:
animal: 1, 2, 3
Time point:
24 h
Score:
<= 1
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Remarks:
Discharge
Basis:
animal: 1, 2, 3
Time point:
other: 48/72 h
Score:
0
Max. score:
3
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal: 1, 2, 3
Time point:
other: 1h
Score:
<= 2
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal: 1, 2, 3
Time point:
24 h
Score:
<= 1
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal: 1, 2, 3
Time point:
other: 24/48 h
Score:
0
Max. score:
4
Reversibility:
other: Not applicable
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No corneal or iridial effects were noted during the study. Moderate conjunctival irritation was noted in all treated eyes one hour after treatment and minimal conjunctival irritation was noted in all treated eyes at the 24-hour observation. All treated eyes appeared normal at the 48-hour observation.
Other effects:
Not applicable
Interpretation of results:
other: Annex I of the CLP Regulation (1272/2008/EC)
Conclusions:
Based on the results of this study, Methyl Nonyl Ketone does not need to be classified for eye irritation in accordance with the criteria outlined in Annex I of the CLP Regulation (1272/2008/EC).
Executive summary:

The study was performed to assess the irritancy potential of the test material to the eye of the New Zealand White rabbit. A volume of 0.1 mL Methyl Nonyl Ketone was applied to the non-irrigated eye right eye of 3 rabbits. Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment, according to the Draize score.

 

No corneal or iridial effects were noted during the study. Moderate conjunctival irritation was noted in all treated eyes one hour after treatment (a score of 2 for redness and discharge, and 1-2 for chemosis). Minimal conjunctival irritation was noted in all treated eyes at the 24-hour observation (a score of 0-1 for redness, discharge and chemosis). All treated eyes appeared normal at the 48-hour observation.

 

Based on these results, the test material does not need to be classified for eye irritation in accordance with the criteria outlined in Annex I of the CLP Regulation (1272/2008/EC).

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

 

Skin: 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).

 

Eye: The study was performed to assess the irritancy potential of the test material to the eye of the New Zealand White rabbit. A volume of 0.1 mL Methyl Nonyl Ketone was applied to the non-irrigated eye right eye of 3 rabbits. Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment, according to the Draize score. 

No corneal or iridial effects were noted during the study. Moderate conjunctival irritation was noted in all treated eyes one hour after treatment (a score of 2 for redness and discharge, and 1-2 for chemosis). Minimal conjunctival irritation was noted in all treated eyes at the 24-hour observation (a score of 0-1 for redness, discharge and chemosis). All treated eyes appeared normal at the 48-hour observation. Based on these results, the test material does not need to be classified for eye irritation in accordance with the criteria outlined in Annex I of the CLP Regulation (1272/2008/EC).

Justification for classification or non-classification

Based on these results methyl nonyl ketone needs to be classified as a category 2 skin irritant, but not as eye irritant, in accordance with the criteria outlined in Annex I of the CLP Regulation (1272/2008/EC).