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EC number: 212-092-1 | CAS number: 762-12-9
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
The delayed contact hypersensivity of didecanoyl peroxide was evaluated in Guinea pigs according to OECD N°406 guideline and in compliance with GLP (Ollivier, 2006). The induction phase has been realized both by intradermal route on day 1 (didecanoyl peroxide 0.5 % in corn oil) and by cutaneous route on day 8 (concentration = 5%). 30 guinea pigs were allocated to 2 groups of guinea pigs: 5 males and 5 females for control group and 10 males and 10 females for treated group. The first challenge phase was realized on day 22 by cutaneous application of didecanoyl peroxide 0.5 %; the cutaneous reactions were scored 24 and 48 hours after the challenge phase. As equivocal cutaneous reactions were noted after the first challenge, a second challenge application was performed on day 36. The test item was applied at the concentration of 0.1% (w/w) in acetone to the left flank and at the concentration of 0.05% (w/w) in acetone to the right flank of animals of both groups, under the same experimental conditions as for the first challenge.
After the first challenge application, a discrete erythema, together with dryness of the skin in one animal at the 48-hour reading, was observed in 3/10 animals of the control group at the 24 and 48-hour reading. In the treated group, a discrete or moderate erythema was noted in 11/20 animals at the 24-hour reading and persisted in seven of them at the 48-hour reading. Dryness of the skin was also recorded in 5/20 animals at the 48-hour reading. After the second challenge application, no relevant cutaneous reactions were recorded. As the cutaneous reactions observed in the animals of the treated group were of similar incidence and severity when compared to those recorded in the animals of the control group, they were not attributed to delayed contact hypersensitivity.
In conclusion, didecanoyl peroxide is considered as non-sensitizing in the Guinea Pigs Maximalisation Test.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 11 august 2004 to 1 october 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Compliant to GLP and testing guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The study was performed before the implementation of the REACH regulation
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories France, l'Arbresle, France
- Age at study initiation: 1-2 months
- Weight at study initiation: males: 348+/-17 g ; females 353 +/-18 g
- Housing: housed individually in polycarbonate cages with stainless steel lid (48 cm x 27 cm x 20 cm) equipped with a propylene bottle
- Diet (e.g. ad libitum): free access to 106 pelleted diet
- Water (e.g. ad libitum): filtered by a FG Millipore membrane (0,22 micron), provided ad libitum
- Acclimation period: 5 days before the beginning of the study
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C +/- 2
- Humidity (%): 30 to 70 %
- Air changes (per hr): 12 cycles/hour
- Photoperiod (hrs dark / hrs light): 12h/12
IN-LIFE DATES: From: 11 august 2004 To: 1 october 2004 - Route:
- intradermal
- Vehicle:
- corn oil
- Concentration / amount:
- 0.5%
- Day(s)/duration:
- Day 1
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: acetone
- Concentration / amount:
- 5%
- Day(s)/duration:
- Day 8
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: acetone
- Concentration / amount:
- 0.5%
- Day(s)/duration:
- Day 22
- Adequacy of challenge:
- highest non-irritant concentration
- No.:
- #2
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: acetone
- Concentration / amount:
- 0.1% (left flanck)
- Day(s)/duration:
- Day 36
- No.:
- #2
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: acetone
- Concentration / amount:
- 0.05% (right flanck)
- Day(s)/duration:
- Day 36
- No. of animals per dose:
- 20 animals per dose
10 animals for controls - Details on study design:
- RANGE FINDING TESTS:
-Compounds solubility: test item was not soluble in 0.9% NaCl and in ethanol/water (80/20, w/w).
For intradermal induction: corn oil was choosen
An homogeneous suspension was observed at the maximum concentration of 5%
For topical application: acetone was choosen
A solution was obtained at the maximum concentration of 25% (w/w)
irritation: For intradermal route, irritation was observed in all tested concentrations (5%, 2.5%, 1%). The concentration chosen for the main study was 0.5% (w/w)
For cutaneous route, irritation score was 2 for 10% and 1 for 5%. The concentration chosen for the main study was 5% (w/w) for the induction phase and 0.5% (w/w) for the challenge application
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: intradermal induction the 1st day, and epicutaneous occlusive patch during 48 hours the 8th day
- Frequency of applications: 3 intradermal injections, 1 topical application
- Duration: the topical application was occlusive during 48 hours
- Site: intradermal induction were performed in the interscapular region of all animals
topical application were performed in the same site
- Concentrations: intradermal induction was 0.5% (w/w); the topical induction was 5%
- Test groups: intradermal induction: 3 injections - FCA with 0.9% NaCl - test item in corn oil -test item in a mixture FCA/0.9% NaCl
Topical application: test item in acetone
- Control group: intradermal induction 3 injections - FCA with 0.9% NaCl - vehicule alone -vehicule in a mixture FCA/0.9% NaCl
Topical application: vehicule alone
B. CHALLENGE EXPOSURE
First challenge
- No. of exposures: 1
- Day of challenge: 22
- Exposure period: 24 hours
- Test groups: occlusive patch with 0.5% of test item
- Control group: occlusive patch with vehicule alone
- Site: the site was the same that induction
- Concentrations: 0.5% of test item
- Evaluation: skin reactions were evaluated approximately 24 and 48 hours after removal of the dressing
2nd challenge
- No. of exposures: 1
- Day of challenge: 36
- Exposure period: 24 hours
- Test groups: occlusive patch with 0.1% of test item in the left flanck, and 0.05% of test item in the right flanck
- Control group: occlusive patch with vehicule alone
- Site: the site was the same that induction
- Concentrations: 0.1% and 0.05% of test item
- Evaluation: skin reactions were evaluated approximately 24 and 48 hours after removal of the dressing - Challenge controls:
- vehicules: for intradermal injections : corn oil, for topical applications: acetone.
- Positive control substance(s):
- yes
- Remarks:
- Mercaptobenzathiole
- Positive control results:
- positive control was a periodic test and was performed in march 2004 (5 months before the test). Substance was Mercaptobenzothiazole (CAS n° 149-30-4). Under experimental conditions and according to the Magnusson and Kligman method, the test item Mercaptobenzothiazole induced positive skin sensitization reactions in 80% guinea pigs
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.5%
- No. with + reactions:
- 11
- Total no. in group:
- 20
- Clinical observations:
- discrete and moderate erythema (grade 1 or 2)
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.5%
- No. with + reactions:
- 7
- Total no. in group:
- 20
- Clinical observations:
- discrete and moderate erythema (grade 1 or 2)
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.5%
- No. with + reactions:
- 3
- Total no. in group:
- 10
- Clinical observations:
- discrete erythema (grade 1)
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.5%
- No. with + reactions:
- 3
- Total no. in group:
- 10
- Clinical observations:
- discrete erythema (grade 1)
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.1%
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Clinical observations:
- discrete erythema (grade 1)
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.1%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.1%
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- discrete erythema (grade 1)
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.1%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.05%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.05%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.05%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.05%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 1%
- No. with + reactions:
- 8
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 1%
- No. with + reactions:
- 8
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under experimental conditions and according to the maximization method of magnusson and Kligman, the test item DIDECANOYL PEROXYDE, should not be considered as a skin sensitizer.
- Executive summary:
The delayed contact hypersensivity of didecanoyl peroxide was evaluated in Guinea pigs according to OECD N°406 guideline (July 17th1992 - Magnusson and Kligman test).
The induction phase has been realized both by intradermal route on day 1 (didecanoyl peroxide 0.5 % in corn oil) and by cutaneous route on day 8 (concentration = 5%). 30 guinea pigs were allocated to 2 groups of guinea pigs: 5 males and 5 females for control group and 10 males and 10 females for treated group. The first challenge phase was realized on day 22 by cutaneous application of didecanoyl peroxide 0.5 %; the cutaneous reactions were scored 24 and 48 hours after the challenge phase. As equivocal cutaneous reactions were noted after the first challenge, a second challenge application was performed on day 36. The test item was applied at the concentration of 0.1% (w/w) in acetone to the left flanck and at the concentration of 0.05% (w/w) in acetone to the right flanck of animals of both groups, under the same experimental conditions as for the first challenge.
No systemic clinical signs and no deaths were noted during the study.
After the first challenge application, a discrete erythema, together with dryness of the skin in one animal at the 48-hour reading, was observed in 3/10 animals of the controle group at the 24 and 48-hour reading.
In the treated group, a discrete or moderate erythema was noted in 11/20 animals at the 24-hour reading and persisted in seven of them at the 48-hour reading. Dryness of the skin was also recorded in 5/20 animals at the 48-hour reading.
After the second challenge application, no relevant cutaneous reactions were recorded.
As the cutaneous reactions observed in the animals of the treated group were of similar incidence and severity when compared to those recorded in the animals of the control group, they were not attributed to delayed contact hypersensitivity.
In conclusion, under these experimental conditions, didecanoyl peroxide was considered as non-sensitizing in the Guinea Pigs Maximalisation Test.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
According to EU Regulation (EC) N0. 1272/2008 (CLP), the substance is not classified for skin sensitisation.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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