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EC number: 223-356-0 | CAS number: 3851-87-4
- 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
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:
- 1995-10-12 to 1995-11-10
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
- 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".
- 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: 314 +/- 13 g (males), 315 +/-20 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 (%): 30-70%
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12 - Route:
- intradermal and epicutaneous
- Vehicle:
- paraffin oil
- Concentration / amount:
- Induction: intradermal application of 10% (w/w) of the test substance in paraffin oil; topical application of the undiluted test substance
Challenge: topical application of 10% (w/w) of the test substance in paraffin oil on right flank, 50% (w/w) of the test substance in paraffin oil on left flank - Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- Induction: intradermal application of 10% (w/w) of the test substance in paraffin oil; topical application of the undiluted test substance
Challenge: topical application of 10% (w/w) of the test substance in paraffin oil on right flank, 50% (w/w) of the test substance in paraffin oil on left flank - No. of animals per dose:
- 20 (10 males and 10 females)
- Details on study design:
- RANGE FINDING TESTS:
- a preliminary test was conducted in order to determine the concentrations to be tested in the main study
- by intradermal route: 0.1 ml of the test substance at different concentrations at the dorsal region between the shoulders; evaluation after 24, 48 hours and six days after injection
- by cutaneous route: 0.5 ml of different concentration of the test substance were applied to a gauze pad (4cm²); occlusive dressing; exposure 24 h; evaluation after 24 and 48 hours after removal of the dressings;
- criteria for dose selection: concentration should be well tolerated systemically and locally; intradermal injections should cause moderate irritant effect; topical application for the induction should cause at most weak or moderate skin reaction; topical application for the challenge should should be the highest concentration which does not cause an irritant effect
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: intradermal route: on day one injection of 0.1 ml; cutanous route: on day 8 topical application of test substance for 48 h
- Test groups: yes (induction with test substance)
- Control group: yes (induction with vehicle)
- Site: dorsal region between the shoulders
- Frequency of applications: intradermal and cutanous route
- Duration: 10 days
- Concentrations: induction: intradermal injection 10 % (w/w) of the test substance in paraffin oil; topical application: 99.0% undiluted test substance
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: day 22
- Exposure period: 1 day (24 h)
- Test groups: yes (challenge with 50% (w/w) and 10% (w/w) of the test substance)
- Control group: yes (challenge with 50% (w/w) and 10% (w/w) of the test substance)
- Site: left and right flank
- Concentrations: topical application: 50% (w/w) of the test substance in paraffin oil on the left flank and 10% (w/w) of the test substance in paraffin oil on the right flank
- Evaluation (hr after challenge): 24 and 48 h after - Challenge controls:
- no
- Positive control substance(s):
- yes
- Remarks:
- 2,4-dinitro chlorobenzene
- Positive control results:
- 2,4-Dinitro chlorobenzene in a concentration of 1% (w/w) induced positive skin sensitization reactions in 100% of the guinea pigs.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50 % (w/w)
- No. with + reactions:
- 16
- Total no. in group:
- 20
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50% (w/w)
- No. with + reactions:
- 11
- Total no. in group:
- 20
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10% (w/w)
- No. with + reactions:
- 5
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10% (w/w)
- No. with + reactions:
- 2
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 50% (w/w)
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50% (w/w)
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 10% (w/w)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 10% (w/w)
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 1% (w/w) 2,4-dinitro chlorobenzene
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 1% (w/w) 2,4-dinitro chlorobenzene
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Remarks on result:
- positive indication of skin sensitisation
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the experimental conditions a cutaneous reactions attributable to the sensitization potential of the test substance were observed in 6 of 20 guinea-pigs when the test substance was applied at 50% (w/w). The test substance did not show sensitization effect at 10% (w/w).
- Executive summary:
The potential of Luperox 219 (Di-3,5,5 -Trimethylhexanoyl)peroxide) in the vehicle paraffin oil to induce delayed contact hypersensitivity was evaluated in guinea-pigs according the maximization method of Magnusson and Kligman and the OECD guideline 406. Thirty guinea-pigs were allocated in 2 groups: a control group, consisting of five males and five females and a treated group consisting of 10 males and 10 females. No clinical signs and no deaths were noted during the study. Cutanous reactions attributable to the sensitization potential of the test substance were observed in 6 of 20 guinea-pigs when the test substance was applied at 50% (w/w). The test substance did not show a sensitization effect at 10% (w/w).
The sensitivity of the guinea-pig was checked in a recent study with a positive sensitizer (2,4 -dinitro chlorobenzene).
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
Cutaneous reactions attributable to the sensitization potential of the test substance were observed in 6 of 20 animals in a Guinea Pig Maximisation Test when the test item was applied at a concentration of 50 % (w/w). No sensitization effect was observed at 10 % (w/w).
Migrated from Short description of key information:
OECD 406 (CIT, 1996)
Justification for selection of skin sensitisation endpoint:
GLP guideline study
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Cutaneous reactions attributable to the sensitization potential of the test substance were observed in 6 of 20 guinea pigs when the test substance was applied at 50 % (w/w). The test item is considered to be a skin sensitizer of medium hazard (Skin Sens 1B).
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