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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 247-987-6 | CAS number: 26762-92-5
- 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
Repeated dose toxicity: dermal
Administrative data
- Endpoint:
- sub-chronic toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: standard NTP test protocol, not all standard parameters assessed The nature of the effects (local at the application site) allows conclusions on the NOAEL
Data source
Reference
- Reference Type:
- other: website data
- Title:
- Unnamed
- Year:
- 2 004
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 411 (Subchronic Dermal Toxicity: 90-Day Study)
- Deviations:
- yes
- Remarks:
- no biochemistry, urinalysis, behavioural effects
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- α,α-dimethylbenzyl hydroperoxide
- EC Number:
- 201-254-7
- EC Name:
- α,α-dimethylbenzyl hydroperoxide
- Cas Number:
- 80-15-9
- IUPAC Name:
- 1-methyl-1-phenylethyl hydroperoxide
- Reference substance name:
- cumene hydroperoxide
- IUPAC Name:
- cumene hydroperoxide
- Test material form:
- not specified
- Details on test material:
- cumene hydroperoxide
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
Administration / exposure
- Type of coverage:
- not specified
- Vehicle:
- ethanol
- Details on exposure:
- - Area of exposure: 10% of total surface (based on an average BW of 200 g and a conversion factor of 5.9 (Kg to m2)*: 0.1 times 0.034 m2 = 34 cm2)
TEST MATERIAL: no detailed data
VEHICLE: ethanol (indicated in the result section of the micronucleus test) 0.5 mL/ kg
* Freireich, EJ, et al. Quantitative comparison of toxicity of anticancer agents in mouse, rat, dog, monkey and man. Cancer Chemother Rep.1966;50(4):219-244 - Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 93 days
- Frequency of treatment:
- daily on week days
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 0.75, 1.5, 3.0, 6.0 and 12 mg/kg bw
Basis:
nominal per unit body weight
- No. of animals per sex per dose:
- 10/sex/dose
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- After a 10- to 14-day quarantine period, animals are assigned at random to treatment groups. The study includes five treatment groups each administered a different concentration of the test article plus a control group. Each group contains 10 animals per sex per species. The animals receive the subject chemical by a designated route of exposure. Controls receive vehicle alone.Animals are exposed five times per week, weekdays only until the day prior to necropsy. All rats are housed individually.
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: twice daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: once weekly
BODY WEIGHT: Yes
- Time schedule for examinations: on day 1 and weekly thereafter
FOOD CONSUMPTION: No
WATER CONSUMPTION: No
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: Yes
on day 93: Erythrocyte count, Mean corpuscular volume, Hemoglobin, Packed cell volume, Mean corpuscular haemoglobin, Mean corpuscular hemoglobin concentration, Erythrocyte morphologic assessment, Leukocyte count, Leukocyte differential, Reticulocyte count, Platelet count and morphologic assessment
CLINICAL CHEMISTRY: No
URINALYSIS: No
NEUROBEHAVIOURAL EXAMINATION: No - Sacrifice and pathology:
- ORGAN WEIGHTS:
Liver, thymus, right kidney, right testis, heart, and lung
GROSS PATHOLOGY: Yes
Adrenal glands, Oral cavity, larynx and pharynx, Brain Ovaries, Clitoral glands, Pancreas, Esophagus, Parathyroid glands, Eyes, Pituitary gland, Femur, Preputial glands, Prostate, Gross lesions, Salivary glands, Harderian glands, Seminal vesicles, Heart and aorta, Skin, site of application (dermal studies), Large intestine (cecum, colon, rectum), Spinal cord, Small Intestine (duodenum, jejunum, ileum), Spleen, Kidneys, Stomach (forestomach and glandular), Liver, Testes, epididymides and vaginal tunics of testes, Lungs and mainstem bronchi, Thymus, Lymph nodes - mandibular and mesenteric, Thyroid gland , Tissue masses, Tongue, Mammary gland with adjacent skin, Trachea, Muscle (thigh), Urinary bladder, sciatic Nerve, Uterus, Nasal cavity and nasal turbinates, Vagina, Zymbal gland
HISTOPATHOLOGY: Yes
A complete histopathologic evaluation inclusive of treatment-related gross lesions on all early death animals regardless of dose group, all control animals and all animals in the highest treatment group. In addition all gross lesions irrespective of the dose group. - Statistics:
- not yet performed
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- 1 moribund
- Dermal irritation:
- effects observed, treatment-related
- Description (incidence and severity):
- at 6 mg/kg bw and above
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- 1 moribund
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- slightly decreased in high dose males
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- primary effect on skin at application site
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- skin lesions
- Histopathological findings: neoplastic:
- not examined
- Details on results:
- CLINICAL SIGNS AND MORTALITY
1 male died at 6 mg/kg bw on day 33 (reduced bodyweight(gain) and hyperplasia at application site), no mortality in females
BODY WEIGHT AND WEIGHT GAIN
males: slightly decreased at 12 mg/kg bw
females: no treatment related effects
HAEMATOLOGY
males: no treatment related effects
females: increased platelets numbers at 6 and 12 mg/kg bw
ORGAN WEIGHTS
males: slightly decreased absolute liver, lung, testis and thymus weights at 12 mg/kg bw (not relative to bodyweight)
females: no treatment related effects
HISTOPATHOLOGY: NON-NEOPLASTIC
epididymus:
inflammation and/or cellular infiltration of lymphocytes in 3/10 males at 12 mg/kg bw
at the application site
sebaceous glands:
hyperplasia in all males and females at 12 mg/kg bw and in 1 male at 6 mg/kg bw
dermis:
inflammation in 10 males and 9 females at 12 mg/kg bw; in 2/10 males at 6 mg/kg bw; in 1/10 males at 1.5 mg/kg bw
epidermis:
degradation, exudate, ulcer, necrosis, hyperkeratosis and and squamous hyperplasia in males and females at 12 mg/kg bw
minimal hyperkeratosis and squamous hyperplasia in males at 6 mg/kg bw
Effects increased in incidence and severity with increasing dose levels
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 3 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: local effects on the application site due to the corrosive nature of the test substance
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
No treatment related systemic effects were identified.
Applicant's summary and conclusion
- Conclusions:
- The NOAEL under the conditions of the study is 3 mg/kg bw
- Executive summary:
Ten rats per sex/dose and 10/sex for controls were treated dermally with the test substance for 13 weeks
at 0, 0.75, 1.5, 3.0, 6.0 and 12 mg/kg bw/day. One male died in the 6 mg/kg bw group. Body weights were slightly decreased in males at 12 mg/kg bw. Treatment related effects were found at the application site which included, hyperplasia of the sebaceous glands inflammation of the dermis and degeneration, exudate, ulcer, necrosis, hyperkeratosis and squamous hyperplasia of the epidermis. The effects increased in severity with increasing dose. No treatment related systemic effects were found. The NOAEL is 3.0 mg/kg bw/day (0.6% or 0.018 mg/cm2 per day).
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.