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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 202-704-5 | CAS number: 98-82-8
- 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
Toxicity to reproduction
Administrative data
- Endpoint:
- reproductive toxicity, other
- Remarks:
- other: Subchronic inhalation study with detailed investigation of reproductive organs
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study with GLP, detailed investigation of reproductive organs in course of a subchronic inhalation study
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline 413
- Deviations:
- no
- GLP compliance:
- yes
- Remarks:
- Bushy Run Research Center, Export, Pennsylvania
- Limit test:
- no
Test material
- Reference substance name:
- Cumene
- EC Number:
- 202-704-5
- EC Name:
- Cumene
- Cas Number:
- 98-82-8
- Molecular formula:
- C9H12
- IUPAC Name:
- isopropylbenzene
- Details on test material:
- - Name of test material (as cited in study report): Cumene (isopropyl benzene, CAS No. 98-82-8)
- Analytical purity: >=99.94% (as determined by GC/FID)
- Impurities (identity and concentrations): Not given
- Lot/batch No.: from Chevron Chemical Company
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Sprague-Dawley Inc.
- Age at study initiation: 8 wks
- Weight at study initiation: Males: 171.4 g; Females: 140.6 g
- Fasting period before study:
- Housing: individually
- Diet (e.g. ad libitum): ad libitum during nonexposure period, powdered Certified Agway Pro Lab RMH 3200 (Agway, Inc.)
- Water (e.g. ad libitum): ad libitum during nonexposure period, tap water (Municippal Authority of Westmoreland County, Greensburg, PA, USA)
- Acclimation period: 1-2 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.9-24.0 °C
- Humidity (%): 47-53 %
- Air changes (per hr): 12.5
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- inhalation: vapour
- Type of inhalation exposure (if applicable):
- whole body
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: heated glass evaporator
- Method of holding animals in test chamber: stainless steel, wire-mesh cages in a 4300L inhalation chamber
- Source and rate of air: Not reported
- Method of conditioning air: Not reported
- System of generating particulates/aerosols: Not reported
- Temperature, humidity, pressure in air chamber: 21.9-24.0 °C, 47-53 %, normal pressure
- Air flow rate: 900L/min
- Air change rate: 12.5 per hour
- Method of particle size determination: Not reported
- Treatment of exhaust air: Not reported
TEST ATMOSPHERE
- Brief description of analytical method used: GC/FID
- Samples taken from breathing zone: yes - Details on mating procedure:
- Not investigated, as study is an OECD Guideline 413 with detailed examination of male reproductive organs.
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Samples were analysed once everey 25-30 min during 6 h exposure by GC/FID
- Duration of treatment / exposure:
- 5 day per week per 13 weeks and 2 or 3 days
- Frequency of treatment:
- 6 h
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 100, 500, and 1200 ppm
Basis:
nominal conc.
- No. of animals per sex per dose:
- 21
- Control animals:
- yes, concurrent no treatment
- Positive control:
- No
Examinations
- Parental animals: Observations and examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule:
- Cage side observations checked in table [No.?] were included.
DETAILED CLINICAL OBSERVATIONS: Yes / No / No data
- Time schedule:
BODY WEIGHT: Yes
- Time schedule for examinations: prior to first exposure and weekly during exposure, and preceding sacrifice
FOOD CONSUMPTION AND COMPOUND INTAKE:
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes, weekly
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No
WATER CONSUMPTION AND COMPOUND INTAKE: Yes
- Time schedule for examinations: weekly - Oestrous cyclicity (parental animals):
- Not investigated, as study is an OECD Guideline 413 with detailed examination of male reproductive organs
- Sperm parameters (parental animals):
- Parameters examined in males (15 per group): sperm count in epididymides, sperm morphology, in epididymides, spermatid count in testis, stages of spermatogenesis in testis
- Litter observations:
- Not investigated, as study is an OECD Guideline 413 with detailed examination of male reproductive organs
- Postmortem examinations (parental animals):
- SACRIFICE
- Male animals: All surviving animals
- Female animals: All surviving animals
GROSS NECROPSY
- Gross necropsy consisted of external and internal examinations
HISTOPATHOLOGY / ORGAN WEIGHTS
The following tissues were prepared for microscopic examination and weighed: - Postmortem examinations (offspring):
- Not investigated, as study is an OECD Guideline 413 with detailed examination of male reproductive organs
- Statistics:
- Leven's test, ANOVA, t-test, Fisher exact test
p< 0.05 (two tailed) - Reproductive indices:
- Not investigated, as study is an OECD Guideline 413 with detailed examination of male reproductive organs
- Offspring viability indices:
- Not investigated, as study is an OECD Guideline 413 with detailed examination of male reproductive organs
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- effects observed, treatment-related
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- not specified
- Other effects:
- not examined
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not examined
- Reproductive function: sperm measures:
- effects observed, treatment-related
- Reproductive performance:
- not examined
Details on results (P0)
No exposure related deaths. One male rat in 1200 ppm was sacrificed moribund because of a cage accident.
BODY WEIGHT AND FOOD CONSUMPTION
No differences in mean body weights. Increased water intake from week 2 to 13.
REPRODUCTIVE FUNCTION: SPERM MEASURES
No cumene related differences in counts of testicular sperms. Mormal morphology and stages of spermatogenesis except for one 1200 ppm rat with difuse testicular atrophy. Abnormalities of the head/tail/junction regions were observed in all groups including controls, but were attributed to individual aberrations and not exposure related.
ORGAN WEIGHTS
at 500 and 1200 ppm: increases in liver, kidney and adreanal glands
at 100 ppm: no effects
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 200 ppm
- Sex:
- male
- Basis for effect level:
- other: sperm count, sperm morphology, spermatogenesis
- Remarks on result:
- other: Generation: only specific investigations within a standard 90d study. Therefore, no P or F1 possible (migrated information)
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- not examined
- Mortality / viability:
- not examined
- Body weight and weight changes:
- not examined
- Sexual maturation:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- not examined
- Histopathological findings:
- not examined
Details on results (F1)
Effect levels (F1)
- Remarks on result:
- other: Not investigated, as study is an OECD Guideline 413 with detailed examination of male reproductive organs.
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Any other information on results incl. tables
Morphological evaluations of epidiymal sperm from rats exposed to cumene for 13 weeks
Findings |
Control |
100 ppm |
500 ppm |
1200 ppm |
No. male animals |
15 |
15 |
15 |
15 |
Total sperm assessed |
3026 |
3118 |
2832 |
2644 |
% normal appearance |
98.7 |
98.5 |
96.9 |
98.0 |
% all anomalies |
1.4 |
1.6 |
3.4 |
2.3 |
% head anomalies |
0.5 |
0.5 |
1.1 |
0.7 |
% tail anomalies |
0.5 |
0.6 |
1.5 |
1.0 |
% junction anomalies |
0.4 |
0.5 |
0.8 |
0.6 |
Applicant's summary and conclusion
- Conclusions:
- No effects on sperm count, sperm morphology, spermatogenesis has been observed in a 90d study in rats up to a concentration of 1200 ppm.
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.