Registration Dossier

Administrative data

Description of key information

Relevant data are available to assess the skin and eye irritation potential of the target substance 1-Methyl-1 phenylethyl peroxyneodecanoate. In a primary dermal irritation study conducted according to guideline OECD 404, three female New Zealand White rabbits were dermally exposed to 0.5 mL of the target substance. Based on the results, no classification for skin irritation is warranted in accordance with CLP criteria.

Supporting data is available from a second primary dermal irritation study conducted similar to OECD 404. In this study, New Zealand rabbits (3/sex) were dermally exposed to 0.5 mL of the target substance (90.2% purity) for 4 hours. Based on the results, no classification for skin irritation is warranted in accordance with CLP criteria.

In a primary eye irritation study conducted according to OECD 405, 0.1 mL of 1-Methyl-1-phenylethyl peroxyneodecanoate (75.6 % purity) was instilled into the conjunctival sac of one eye of three male New Zealand White Rabbits. In this study, 1-Methyl-1-phenylethyl peroxyneodecanoate did not meet GHS criteria and was therefore considered non-irritant to the eye.

Based on the results of the studies, the target substance can be considered non-irritant to the skin and eye. 

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1992-11-24 to 1993-03-16
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
1981
Deviations:
no
GLP compliance:
yes (incl. certificate)
Specific details on test material used for the study:
- Name: Cumylperoxyneodecanoate
- Brand name: Trigonox 99-C75
- Batch No.: 0509207222002
- Purity: 75% in aromatic free mineral spirit (CAS No.: 31807-55-3 and 26748-47-0)
- Storage: freezer

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing:
An appropriate quantity of the test material, as supplied by the Sponsor, was dispensed on the day of dosing.
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Froxfield S.P.F. Rabbits, Broadway Farm, Froxfield, Hampshire, England
- Age at study initiation: Animals were approximately 4 months old
- Weight at study initiation: 3.35 - 3.60 kg
- Housing: The animals were individually housed in suspended stainless steel cages mounted in mobile batteries. The cages were fitted with perforated counter-sunk floor panels. A tray beneath the floor was lined with absorbent paper which was changed regularly.
- Diet (e.g. ad libitum): ad libitum; commercially available standard pelleted rabbit diet (S.Q.C. Rabbit Diet, Special Diets Services Limited, Witham, Essex, England).
- Water (e.g. ad libitum): ad libitum; tap water taken from the public supply; in England the supply and quality of this water is governed by Department of the Environment regulations.
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 - 20 °C
- Humidity (%): 52 - 60%
- Air changes (per hr): 15 complete air changes per hour without re-circulation
- Photoperiod (hrs dark / hrs light): electric time-switches operated a lighting cycle of 12 hours of artificial light per day
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): a single dose (0.5 mL) was applied directly to the skin
Duration of treatment / exposure:
4 hours exposure period
Observation period:
1, 24, 48, 72 hours after removal of the bandages. Additional observation of persistent effects of treatment were made 6, 9, 12 and 15 days after treatment.
Number of animals:
3.
A single animal was initially treated. In the absence of a severe irritation response in this sentinel animal, the remaining two animals were committed to the study.
Details on study design:
TEST SITE
- Area of exposure: 6 x 6 cm
- Type of wrap if used: Test material was covered by an unmedicated gauze patch which was held in place on the place on the left test site by strips of Blenderm (Community Care Products, 3M Health Care, Loughborough, England). Pads of cotton whool and elasticated bandage were used to protect the patches and ensure good contact between the skin and the test material.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the treatment sites were gently washed with warm water and dried with paper towels to remove excess test material adhering to the skin.

OBSERVATION TIME POINTS
Assessment of skin irritation responses at the control and treated test sites were made 1, 24, 48 and 72 hours after removal of the bandages. Additional observations of persistent effects of treatment were made 6, 9, 12 and 15 days after treatment.

SCORING SYSTEM:
- Method of calculation:
Reactions of the test sites were assessed according to the criteria of Draize (1959) (for details see Table 1 in box 'Any other information on material and methods').
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 15 days
Remarks on result:
positive indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 15 days
Remarks on result:
positive indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 15 days
Remarks on result:
positive indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 15 days
Remarks on result:
positive indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 15 days
Remarks on result:
positive indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Well-defined or moderate erythema and very slight to moderate eedema were observed in two rabbits during the first 72 hours following bandage removal. Loss of elasticity was observed in both of these rabbits during the first week of observation. The area affected by these changes extended 2-3 cm beyond the test site of one of these rabbits. On the sixth day, very slight erythema and edema were observed, with the addition of exfoliation. On the ninth and twelfth days, exfoliation was still present in both animals. The test sites of these two animals were overtly normal on the 15th day.
The remaining rabbit showed very slight erythema during the first 72 hours following bandage removal. Very slight edema was also observed at the one-hour examination. Loss of elasticity was observed at 24-hour examination, and persisted until the 12th day. Exfoliation was evident during the latter part of the first week of observation. The test site of this animal was overtly normal on the fifteenth day after treatment.
The test sites of all three animals were sticky to touch at the one and 24-hour examinations. The effect was considered to have been caused by residual dose material and adhering to the skin after the washing procedure. This occurrence did not affect the assessment of the skin responses.
The control site of each animal did not show any response to the control procedure.
The mean values for erythema in two animals and edema in one animal, recorded 24, 48 and 72 hours after treatment, equaled or exceeded the EEC limit values considered to indicate a significant inflammatory response to treatment.

Mean Values for erythema and oedema are summed up in table 2 in box 'Any other information on results incl. tables'.

Table 2: Mean values for erythema and oedema 24, 48, 72 hours after treatment

Animal number and sex Erythema* Oedema*
Test Control Test Control
23TJ 811F 3.0 0.0 2.0 0.0
23TJ 816F 2.0 0.0 1.3 0.0
23TJ 823F 1.0 0.0 0.0 0.0

* Values based on criteria documented in Table 1 in box 'Any other information on material and methods'.

Table 3: Scoring of irritance responses*

Test site: 0.5 mL Trigonox 99 -C75

Control site: No treatment

both: semioccluded for 4 hours

    Score after removal of dressings
Animal number and sex Type of Response 1 hour 24hour 48 hour 72 hours
Test site Control site Test site Control site Test site Control site Test site Control site
23TJ 811F Erythema 3 0 3 0 3 0 3 0
STW STW TW TW  
Oedema 3 0 2 0 2 0 2 0
23TJ 816F Erythema 2 0 2 0 2 0 2 0
ST ST T T  
Oedema 2 0 2 0 1 0 1 0
23TJ 823F# Erythema 1 0 1 0 1 0 1 0
S ST TX TX  
Oedema 1 0 0 0 0 0 0 0

* Criteria documented in Table 1 in box 'Any other information on material and methods'.

# Sentinel animal

S Sticky to touch

T Loss of elasticity

W Area affected extends to 2 -3 cm beyond test site/application site

X Exfoliation

Table 4 : Scoring of irritance response*

Test site: 0.5 mL Trigonox 99 -C75

Control site: No treatment

both: semioccluded for 4 hours

    Score after removal of dressings
Animal number and sex Type of Response 6 days 9 days 12 days 15 days
Test site Control site Test site Control site Test site Control site Test site Control site
23TJ 811F Erythema 1 0 0 0 0 0 0 0
TWX WX X  
Oedema 1 0 0 0 0 0 0 0
23TJ 816F Erythema 2 0 0 0 0 0 0 0
TX X X  
Oedema 1 0 0 0 0 0 0 0
23TJ 823F# Erythema 0 0 0 0 0 0 0 0
TX T T  
Oedema 0 0 0 0 0 0 0 0

* Criteria documented in Table 1 (in box "Any other information on material and methods").

# Sentinel animal

S Sticky to touch

T Loss of elasticity

W Area affected extends to 2 -3 cm beyond test site/application site

X Exfoliation

Interpretation of results:
GHS criteria not met
Conclusions:
Based on the results and in accordance to the CLP regulation no classification for skin irritation is warranted.
Executive summary:

In a primary dermal irritation study according to guideline OECD 404, 3 female New Zealand White rabbits (4 months old, 3.35 - 3.60 kg) were dermally exposed to 0.5 mL of Trigonox 99 -C75 to the closely-clipped dorsal (6 x 6 cm) of the left site. Test sites were covered with a semi-occlusive dressing for 4 hours. Animals were then observed for 15 days.

Well-defined or moderate erythema and very slight to moderate edema were observed in two rabbits during the first 72 hours following bandage removal. Loss of elasticity was observed in both of these rabbits during this time. On the sixth day very slight erythema and edema and loss of elasticity were observed, with the addition of exfoliation. On the ninth and twelfth days, exfoliation was still present in both animals. The remaining rabbit showed very slight erythema during the first 72 hours following bandage removal. Very slight edema was also observed at the one-hour examination. Loss of elasticity was observed at the 24-hour examination and persisted until the 12th day. Exfoliation was evident during the latter part of the first week of observation. The test sites of all animals were overtly normal on the 15th day after treatment.

In this study, Trigonox 99 -C75 is not a dermal irritant based on CLP criteria.

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
to 1978-02-08
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
not specified
Specific details on test material used for the study:
TEST MATERIAL
- Name: Cumyl peroxyneodecanoate (SN-1-4462-71)
- Purity: 90.2 %
- Appearance: viscous yellowish liquid
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Kuiper's Rabbit Ranch, Gary, Indiana
- Weight at study initiation: 2005 - 2045 g
- Housing: Animals housed individually, in hanging wire-mesh cages in temperature and humidity controlled quarters
- Water: ad libitum
- Diet: ad libitum; Purina Rabbit Chow
Type of coverage:
occlusive
Preparation of test site:
clipped
Remarks:
The skin of 3 rabbits was abraded with a scalpel blade (not deep enough to cause bleeding)
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
0.5 mL
Duration of treatment / exposure:
4 h
Observation period:
72 h
Number of animals:
3 female, 3 male
Details on study design:
TEST SITE
- Area of exposure: back
- % coverage: 20 - 30% of the body surface
- Type of wrap if used: The application sites were covered with gauze bandaging and occluded with Saran Wrap.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes,with tepid tap water
- Time after start of exposure: 4 hours

OBSERVATION TIME POINTS
Immediately after washing, 24 h, 48 h, 72 h

SCORING SYSTEM:
- Method of calculation: Scoring according to the method of Draize. See Tables 1 and 2 in box 'Any other information on materials & methods incl. tables'
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.7
Max. score:
4
Reversibility:
not specified
Remarks on result:
positive indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.8
Max. score:
4
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.3
Max. score:
4
Reversibility:
not specified
Remarks on result:
positive indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.8
Max. score:
4
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Slightly irritating response immediately until 72 hours after exposure was observed in all animals. For individual results see Table 4 in box 'Any other information on results incl. tables'.

Individual Rabbit Scores and Score Calculation

Table 4: Intact Skin

 

Erythema

Edema

 

Observation Period (Hours)

Observation Period (Hours)

Animal No./Sex

4

24

48

72

4

24

48

72

30569/Male

0.5

0

1.0

1.0

0

0

1.0

1.0

30584/Female

1.0

1.0

2.0

2.0

1.0

0.5

1.0

1.0

30586/Female

1.0

1.0

1.5

1.5

0.5

0.5

1.0

1.0

Total

2.5

2.0

4.5

4.5

1.5

1.0

3.0

3.0

Average Value

0.8

0.7

1.5

1.5

0.5

0.3

1.0

1.0

Interpretation of results:
GHS criteria not met
Conclusions:
In this study, Cumyl peroxyneodecanoate (SN-1-4462-71) is not a dermal irritant.
Executive summary:

In a primary dermal irritation study (similar to OECD 404), 3 White New Zealand male and White New Zealand 3 female rabbits (2005 - 2045 g) were dermally exposed to 0.5 mL Cumyl peroxyneodecanoate (1 -Methyl-1-phenylethyl peroxyneodecanoate) with a purity of 90.2% for 4 hours to 20 – 30% of their body surface. 4 hours after application, the bandage and the remaining substance has been removed from the skin. Animals then were observed for 72 h. Irritation was scored by the method of Draize. Slight irritation and corrosion was caused by the test substance after a 4 h dermal application.

Under the condition of the present study, no skin irritation or corrosion was caused by Cumyl peroxyneodecanoate after a 4 h dermal application. In this study, Cumyl peroxyneodecanoate is not irritating to the skin according to CLP criteria.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not 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:
1998-06-30 to 1998-12-31
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:
24 February 1987
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
31 July 1992
Deviations:
no
GLP compliance:
yes
Specific details on test material used for the study:
TEST MATERIAL
- Name: Peroxyneodecanoate de cumyle
- CAS No.: 26748-47-0
- Brand name: LUPEROX 188 M 70
- Batch No.: XX200001
- Appearance: colourless liquid
- Purity: 75.6% in isododecane
- Origin: Laporte Organics-Peroxide-Chemie
- Storage: - 20 °C, protected from light
- Expiry date: September 1998
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Elevage Cunicole de Val de Selle, 80160 Prouzel, France
- Weight at study initiation: 2.3 +/- 0.3 kg
- Number per sex: 3 male
- Housing: individually, polystyrene cages (35 cm x 55 cm x 32 cm or 48.2 cm x 58 cm x 36.5 cm)
- Diet: ad libitum; 112 C pelleted diet (UAR, 91360 Villemoisson-sur-Orge, France)
- Water: ad libitum; drinking water filtered by FG Millipore membrane (0.22 micron)
- Acclimatisation period: At least 5 days
- Identification: metal tag in the ear

ENVIRONMENTAL CONDITIONS
- Temperature: 18 +/- 3 °C
- Humidity: 30 - 70 %
- Air changes: 12 cycles/hour, filtered, non-recycled air
- Photoperiod (hrs dark / hrs light): 12 h/12 h
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
once; eyes were not rinsed after administration
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
3 male rabbits
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The eyes were not rinsed after administration of the test substance.
SCORING SYSTEM: Scoring according to the method of Draize (see Table 1 in box ‘Any other information on materials & methods incl. tables’).
TOOL USED TO ASSESS SCORE: Cornea: direct examination or, if necessary, with an Ultra-Violet lamp
To determine the presence or absence of corneal opacification and to evaluate the affected area, one or two drops of 0.5% sodium fluorescein solution can be instilled into the eye (however, this must not be performed before the 24-hour reading). If corneal opacification is difficult to determine, the eye can be examined under a UV lamp (a clear fluorescence is visible in the areas of opacification).
As possible irritant effects were anticipated, the test substance was evaluated in one animal in a first assay. Since the test substance was not severely irritant in this first assay, it was evaluated in a second assay on two other animals.
A single dose of 0.1 mL of the undiluted test substance was instilled into the conjunctival sac of the left eye after gently pulling the lower lid away from the eyeball.
The lower and upper eyelids were held together for about one second to avoid any loss of the test substance. The right eye, which remained untreated, served as control.
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.7
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.7
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Only very slight or slight conjunctival reactions (very slight or slight chemosis and very slight redness of the conjunctiva) were observed in all animals which were fully reversible within 72 hours at the latest.

Table 2: Individual ocular examinations and mean values of the scores recorded at each reading (24, 48 and 72 hours) for each animal

Rabbit number

Region of eye

Description of ocular reactions

Scores

Mean irritation score (1)

Interpretation

(+)

(-)

1h

D1

24h

D2

48h

D3

72h

D4

01

Conjunctivae

Chemosis

2

1

0

0

0.3

(-)

Redness

1

1

1

0

0.7

(-)

Discharge

0

0

0

0

0.0

 

Iris

 

0

0

0

0

0.0

(-)

Corneal opacity

Intensity

0

0

0

0

0.0

(-)

Area

0

0

0

0

0.0

 

Other

 

*

*

*

*

 

 

Fluorescein

 

/

U

/

/

 

 

02

Conjunctivae

Chemosis

1

1

0

0

0.3

(-)

Redness

1

1

0

0

0.3

(-)

Discharge

0

0

0

0

0.0

 

Iris

 

0

0

0

0

0.0

(-)

Corneal opacity

Intensity

0

0

0

0

0.0

(-)

Area

0

0

0

0

0.0

 

Other

 

*

*

*

*

 

 

Fluorescein

 

/

U

/

/

 

 

03

Conjunctivae

Chemosis

1

1

1

0

0.7

(-)

Redness

1

1

1

0

0.7

(-)

Discharge

0

0

0

0

0.0

 

Iris

 

0

0

0

0

0.0

(-)

Corneal opacity

Intensity

0

0

0

0

0.0

(-)

Area

0

0

0

0

0.0

 

Other

 

*

*

*

*

 

 

Fluorescein

 

/

U

/

/

 

 

(1) mean of scores on days 2, 3 and 4

h = hour

D = day

(+) = irritant according to E.E.C. criteria

(-) = non-irritant according to E.E.C. criteria

* = None

U = Flourescein batch No. 9809

/ = Fluorescein not used

Interpretation of results:
GHS criteria not met
Conclusions:
Under experimental conditions, the test substance LUPEROX 188 M 70 (batch No. XX200001) is non-irritant to the eyes of rabbits.
Executive summary:

In a primary eye irritation study according to OECD 405, 0.1 mL of 1 -Methyl-1-phenylethyl peroxyneodecanoate (75.6 % purity) was instilled into the conjunctival sac of one eye of three male New Zealand White Rabbits (approx. 2.3 kg). Animals were observed for 72 hours with examination at 24, 48 and 72 h after test substance administration. Eye lesions were scored by the method of Draize. Only very slight or slight conjunctival reactions (very slight or slight chemosis and very slight redness of the conjunctiva) were observed in all animals which were fully reversible within 72 hours at the latest.

Under the conditions of the present study, a single ocular application of the test item to rabbits produced no adverse effects on cornea, iris or conjunctivae in any animal. No mortalities nor clinical signs of toxicity were observed.

In this study, 1 -Methyl-1-phenylethyl peroxyneodecanoate did not meet GHS criteria and was therefore considered non-irritant.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Relevant data are available to assess the skin and eye irritation potential of the target substance 1-Methyl-1 phenylethyl peroxyneodecanoate.

In a primary dermal irritation study conducted according to guideline OECD 404, three female New Zealand White rabbits were dermally exposed to 0.5 mL of the target substance. Based on the results, no classification for skin irritation is warranted in accordance with CLP criteria.

Supporting data is available from a second primary dermal irritation study conducted similar to OECD 404. In this study, New Zealand rabbits (3/sex) were dermally exposed to 0.5 mL of the target substance (90.2% purity) for 4 hours. Based on the results, no classification for skin irritation is warranted in accordance with CLP criteria.

In a primary eye irritation study conducted according to OECD 405, 0.1 mL of 1-Methyl-1-phenylethyl peroxyneodecanoate (75.6 % purity) was instilled into the conjunctival sac of one eye of three male New Zealand White Rabbits. In this study, 1-Methyl-1-phenylethyl peroxyneodecanoate did not meet GHS criteria and was therefore considered non-irritant to the eye.

Based on the results of the studies, the target substance can be considered non-irritant to the skin and eye. 

Justification for classification or non-classification

Based on the results from suitable in vivo tests (OECD 404, 405), no classification for skin and/or eye irritation is warranted for the target substance.