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EC number: 240-282-4 | CAS number: 16111-62-9
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1996-04-25 to 1996-05-28
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The GPMT is an accepted method for hazard identification of skin sensitising substances as recommended in "ECHA guidance R.7a: Endpoint specific guidance".
Test material
- Reference substance name:
- Bis(2-ethylhexyl) peroxydicarbonate
- EC Number:
- 240-282-4
- EC Name:
- Bis(2-ethylhexyl) peroxydicarbonate
- Cas Number:
- 16111-62-9
- Molecular formula:
- C18H34O6
- IUPAC Name:
- 3-({[({[(2-ethylhexyl)oxy]carbonyl}peroxy)carbonyl]oxy}methyl)heptane
- Reference substance name:
- Di-(2-Ethylhexyl)-Peroxydicarbonate
- IUPAC Name:
- Di-(2-Ethylhexyl)-Peroxydicarbonate
- Details on test material:
- - Name of test material (as cited in study report): Luperox 223-M-75 (Di-(2-ethylhexyl)-peroxydicarbonate)
- Substance type: organic peroxide
- Physical state: colourless liquid
- Analytical purity: 75.8% in isodecan
- Lot/batch No.: 802-9409-01
- Storage condition of test material: at -20°C and protected from light
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Centre d´Elevage Lebeau, 78950 Gambais, France
- Age at study initiation: approx. 3 month
- Weight at study initiation: 327 +/-18 g (males), 347 +/- 16 g (females)
- Housing: individually
- Diet (e.g. ad libitum): free access
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days before the beginning of the study
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 2°C
- Humidity (%): 30 to 70%
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- paraffin oil
- Concentration / amount:
- Induction: intradermal injection of 2.5 % (w/w) Luperox 223-M-75 in a mixture paraffin oil/Isododecan
topical application of Luperox 223-M-75 undiluted
Challenge: topical application of 50% (w/w) Luperox 223-M-75 in Isododecan
topical application of Luperox 223-M-75 undiluted
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- Induction: intradermal injection of 2.5 % (w/w) Luperox 223-M-75 in a mixture paraffin oil/Isododecan
topical application of Luperox 223-M-75 undiluted
Challenge: topical application of 50% (w/w) Luperox 223-M-75 in Isododecan
topical application of Luperox 223-M-75 undiluted
- No. of animals per dose:
- 20 (10 males and 10 females)
- Details on study design:
- RANGE FINDING TESTS: preliminary test to determine the concentrations to be tested in the main study
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: intradermal and topical application -> 2
- Exposure period: 48 h exposure of topical application
- Test groups: application of the 0.5 ml test substance: intradermal 2.5% (w/w) in a mixture paraffin oil/isododecan; topical application: undiluted
- Control group: group 1: intradermal and topical application of the vehicle; group 2: intradermal application 50% (w/w) isododecane in paraffin oil and topical application of the solvent Isododecan undiluted
- Site: dorsal region between the shoulders
- Frequency of applications: 1
- Duration: 10 days
- Concentrations: 2.5% (w/w) in a mixture paraffin oil/isododecan; undiluted;
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 1 (24 h)
- Exposure period: 24 h
- Test groups: 1 test group
- Control group: 2 control groups
- Site: right and left flank
- Concentrations:
Control group 1: test substance and isododecan in original form
Control group 2: isododecan 50% (w/w) in paraffin oil and in its original form
Treated group 3: test substance concentration 50% (w/w) in paraffin oil and in its original form
- Evaluation (hr after challenge): scoring after 24 h, 48 h, and after 72 h - Challenge controls:
- Isododecan at 50% (w/w) in paraffin oil and undiluted
- Positive control substance(s):
- yes
- Remarks:
- recent study with positive sensitizer: 2,4-dinitro chlorobenzene
Results and discussion
- Positive control results:
- 2,4- dinitro chlorobenzene in a concentration of 1% (w/w) induced positive skin sensitization reactions in 75 % of the guinea-pig
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50%. No with. + reactions: 20.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 75.8 % in Isododecan
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 75.8 % in Isododecan. No with. + reactions: 20.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50%. No with. + reactions: 20.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 75.8 % in Isododecan
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 75.8 % in Isododecan. No with. + reactions: 20.0. Total no. in groups: 20.0.
Any other information on results incl. tables
Table 1: Control group 1 skin reactions
Sex |
Animal number |
24 h Erythema |
24 h Oedema |
48 h Erythema |
48 h Oedema |
72 h Erythema |
72 h Oedema |
||||||
LF |
RF |
LF |
RF |
LF |
RF |
LF |
RF |
LF |
RF |
LF |
RF |
||
Male |
61 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0/S |
0/S |
0 |
0 |
|
62 |
0/S |
0 |
0 |
0 |
0/S |
0 |
0 |
0 |
0/S |
0/S |
0 |
0 |
|
63 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0/S |
0/S |
0 |
0 |
|
64 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0/S |
0/S |
0 |
0 |
|
65 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0/S |
0/S |
0 |
0 |
Female |
81 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0/S |
0/S |
0 |
0 |
|
82 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0/S |
0/S |
0 |
0 |
|
83 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0/S |
0/S |
0 |
0 |
|
84 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0/S |
0/S |
0 |
0 |
|
85 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
LS |
0 |
0 |
0 |
Table 2: Control group 2 skin reactions
Sex |
Animal number |
24 h Erythema |
24 h Oedema |
48 h Erythema |
48 h Oedema |
72 h Erythema |
72 h Oedema |
||||||
LF |
RF |
LF |
RF |
LF |
RF |
LF |
RF |
LF |
RF |
LF |
RF |
||
Male |
66 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0/S |
0/S |
0 |
0 |
|
67 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0/S |
0/S |
0 |
0 |
|
68 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0/S |
0/S |
0 |
0 |
|
69 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0/S |
0/S |
0 |
0 |
|
70 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0/S |
0 |
0 |
0 |
Female |
86 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0/S |
0/S |
0 |
0 |
|
87 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0/S |
0 |
0 |
|
88 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0/S |
0 |
0 |
|
89 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0/S |
0/S |
0 |
0 |
|
90 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0/S |
0/S |
0 |
0 |
Table 3: Treated group skin reactions
Sex |
Animal number |
24 h Erythema |
24 h Oedema |
48 h Erythema |
48 h Oedema |
72 h Erythema |
72 h Oedema |
||||||
LF |
RF |
LF |
RF |
LF |
RF |
LF |
RF |
LF |
RF |
LF |
RF |
||
Male |
71 |
2/S/A |
2/S/A |
0 |
0 |
LS |
LS |
2 |
2 |
0/S |
0/S |
0 |
2 |
|
72 |
2/S/A |
2/S/A |
0 |
0 |
LS |
LS |
2 |
2 |
0/S |
0/S |
2 |
2 |
|
73 |
2 |
2 |
2 |
2 |
2 |
2 |
2 |
2 |
LS/A |
0/S |
2 |
2 |
|
74 |
2 |
2 |
0 |
0 |
2/S |
2/S |
0 |
0 |
0/S |
0/S/A |
0 |
0 |
|
75 |
1 |
1 |
0 |
0 |
2/S |
1/S |
0 |
0 |
LS/A |
LS |
0 |
0 |
|
76 |
2 |
2 |
0 |
0 |
1/S |
2/S |
0 |
0 |
LS/A |
0/S |
0 |
0 |
|
77 |
3/S/A |
3/S/A |
2 |
2 |
4/S |
4/S |
2 |
2 |
LS/A |
2/S |
2 |
2 |
|
78 |
1 |
2 |
0 |
2 |
2/S |
3/S |
2 |
2 |
LS/A |
LS/A |
2 |
2 |
|
79 |
2 |
2 |
0 |
0 |
3/S |
3/S |
2 |
2 |
0/S |
0/S |
0 |
0 |
|
80 |
1 |
2 |
0 |
0 |
LS |
2/S |
2 |
2 |
0/S |
0/S/A |
0 |
0 |
Female |
91 |
2/S |
2/S |
2 |
2 |
LS |
LS |
2 |
2 |
LS |
LS |
0 |
0 |
|
92 |
2/S |
2/S |
2 |
2 |
3/S |
4/S |
2 |
2 |
LS/A |
LS/A |
0 |
0 |
|
93 |
1 |
2 |
2 |
2 |
2/S |
2/S |
2 |
2 |
LS/A |
LS |
0 |
0 |
|
94 |
2 |
2 |
2 |
2 |
3/S |
3/S |
2 |
2 |
LS/A |
LS/A |
0 |
0 |
|
95 |
2 |
2 |
2 |
2 |
LS |
LS |
2 |
2 |
LS |
LS |
2 |
2 |
|
96 |
3/S |
3/S |
2 |
2 |
3/S |
LS |
2 |
2 |
LS/A |
LS |
0 |
0 |
|
97 |
2 |
2 |
2 |
2 |
LS |
LS |
2 |
2 |
0/S |
LS |
0 |
0 |
|
98 |
2 |
2 |
2 |
2 |
LS |
LS |
2 |
2 |
LS |
LS |
0 |
0 |
|
99 |
3 |
3 |
0 |
0 |
2/S |
2/S |
0 |
0 |
LS/A |
0/S |
0 |
0 |
|
100 |
2/S |
3 |
2 |
2 |
LS |
LS |
2 |
2 |
LS |
LS |
2 |
2 |
LF: left flank
RF: right flank
S: dryness of the skin
A: crusts
LS: scoring masked by a severe dryness of the skin
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Cutaneous reactions attributable to the sensitization potential of the test item were observed in 100% of the test animals. The reactions are not attributable to the solvent Isodecan
- Executive summary:
In a dermal sensitization study with Di-(2-Ethylhexyl)-Peroxydicarbonate (2.5%) in isododecan,40 Dunkin-Hartley Guinea Pigs (10/sex) were tested using the method of Magnusson and Klingman (GPMT). Positive control was 2,4-dinitro chlorobenzene; Isododecan was tested as solvent control.
In the treated group, marked cutaneous reactions, similar on both flanks, were observed. Slight to severe erythema (grade 1 to 4) were noted in all animals at the 24 h and the 48 h readings. These reactions were attributed to a sensitizing effect in 100% treated animals. No clinical signs and no mortality were observed. The body weight gain was normal.In this study, Chemical Di-(2-Ethylhexyl)-Peroxydicarbonate is a dermal sensitizer.
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