Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 413-910-1 | CAS number: 1467668-33-2 LUPEROX 610-E-35; LUPEROX 610-E-50; LUPEROX 610-EN-50; LUPEROX 610-M-50; LUPERSOL 610; LUPERSOL 610-M-50
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 3-hydroxy-1,1-dimethylbutyl 2-ethyl-2-methylheptaneperoxoate
- EC Number:
- 413-910-1
- EC Name:
- 3-hydroxy-1,1-dimethylbutyl 2-ethyl-2-methylheptaneperoxoate
- Cas Number:
- 1467668-33-2
- Molecular formula:
- C16H32O4
- IUPAC Name:
- 4-hydroxy-2-methylpentan-2-yl 2-ethyl-2-methylheptaneperoxoate
- Details on test material:
- - Batch number: sample no.1
- Purity: 90.5 %
- Before the treatment, the test substance was stored at -20°C and protected from light and was stored at +4 °C during the treatment
- The pH of the test substance specified in the test article description was between 5 and 7.
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Strain: New-Zealand albino
- Sex: male
- Source: Elevage Cunicole de Val de Selle (80160 Prouzel, France)
- Age: no data
- Weight at study initiation: 2.4 ± 0.1 kg
- Controls: auto-control (left flank)
-Upon their arrivai at C.I.T., the animals were acclimatized to the experimental environment for at least 5 days during which they were observed daily.
-They were individually identified with metallic ear-tags.
ENVIRONMENTAL CONDITIONS
- Temperature : 22 ± 3°C
- Humidity : 50 ± 20% relative humidity
- Light/dark cycle: 12 hours of light/12 hours of dark
- The air was non-recycled and filtered by absolute filters.
- Food and water: ad libitum
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- other: none
- Controls:
- other: The left flank did not receive any substance and served as a control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 mL:
- Concentration : undiluted - Duration of treatment / exposure:
- 4 hour(s)
- Observation period:
- The cutaneous reactions were evaluated one hour then 24, 48 and 72 hours after removal of the semi-occlusive dressing and then daily until day 15.
- Number of animals:
- 3
- Details on study design:
- - Area of exposure: right flank, 6 cm2
- Total quantity applied: 0.5 ml
- Administration frequency: once
- Removal of test substance: no
EXAMINATIONS:
- Scoring system: Draize's score
- Examination time points: 1h, 24 h, 48 h and 72 hours after the patch removal.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: 1 and 2
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Remarks on result:
- other: Desquamation up to d15
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 2.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 9 days
- Remarks on result:
- other: Desquamation up to d15
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- edema score
- Basis:
- animal: 2 and 3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 2.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritant / corrosive response data:
- A marked skin inflammation (erythema: mean scores of 2.7 to 3.0 and oedema: mean scores of 2.0 to 2.7) was observed during at least 72 hours. Reversibility of the oedema was recorded on day 7 and erythema was no longer observed on day 10. Between days 7 and 15, desquamation of the skin, signs of superficial reversible damages of the skin were observed in the 3 animals
Any other information on results incl. tables
No residual test substance was observed after removal of the dressing.
Mean calculated score for each site
Observation period (hours)
1 24 48 72
Erythema 3,0 3,0 3,0 2,7
Oedema 3,0 3,0 2,7 1,7
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Remarks:
- Migrated information
- Executive summary:
The skin irritation potential of 3-hydroxy-1,1-dimethylbutylperoxy-neodecanoate was assessed in a skin irritation test conducted according to the OECD 404 guideline (GLP study)
A single dose of 0.5 ml of the test substance in its original form was prepared on a dry compress then applied to a 6 cm2 clipped areas of 3 male New Zealand White rabbits. The test substance was held in contact with the skin for 4 hours by means of a semi-occlusive dressing. The cutaneous reactions were observed one hour, 24, 48 and 72 hours after removal of the dressing and then daily until day 15. No residual test substance was observed after removal of the dressing. The mean score of the scores recorded after 24, 48 and 72 hours for each animal was calculated.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.