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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

Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Test performed according to guideline standard with GLP. Study result has been published in peer-reviewed journal.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- GLP compliance:
- yes
- 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):
- Analytical purity: >99.9%
- Impurities (identity and concentrations): Not given
- Supplier: Chevron Chemical, Pittsburgh, USA
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratory (Portage, MI, USA)
- Age at study initiation: 60d + 14d
- Weight at study initiation: 213 - 251g
- Fasting period before study: not reported
- Housing: individually
- Diet (e.g. ad libitum): Prolab Certified Rodent Food (Agway, St. Marys, OH, USA)
- Water (e.g. ad libitum): Not specified
- Acclimation period: 14d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17.2 - 22.8 °C5
- Humidity (%): 50 - 65 %
- Air changes (per hr): 14 per hour
- 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: 4320 L rectangular glass and stainless steel chambers (Wahmann Manufacturing, Timonium, MD, USA)
- Method of holding animals in test chamber: individually
- Source and rate of air: Not reported
- Method of conditioning air: Not reported
- Temperature, humidity, pressure in air chamber: 17.2 - 22.8 °C, 50 - 65 %
- Air flow rate: 900L/min
- Air change rate: 14 per hour
- Treatment of exhaust air: Not reported
TEST ATMOSPHERE
- Brief description of analytical method used: GC/FID
- Samples taken from breathing zone: no - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Concentrations were monitored once every 30 min during each 6h exposure period.
- Details on mating procedure:
- - Impregnation procedure: cohoused
- M/F ratio per cage: 1:1
- Proof of pregnancy: vaginal plug referred to as day 0 of pregnancy - Duration of treatment / exposure:
- 6h/day
- Frequency of treatment:
- GD 6-15
- Duration of test:
- until GD 21
- No. of animals per sex per dose:
- 25
- Control animals:
- yes
- Details on study design:
- - Dose selection rationale: Based on preliminary range finding studies conducted in the same laboratory
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: daily
BODY WEIGHT: Yes
- Time schedule for examinations: GD 0, 6, 9, 12, 15, 18, and 21
FOOD CONSUMPTION AND COMPOUND INTAKE: Yes
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day # 21
- Organs examined: gravid uterus, ovaries (incl. corpora lutea), cervix, vagina, abdominal and thoracic cavities, upper and lower respiratory tracts incl. nasal turbinates)
OTHER: liver weights recorded - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of early resorptions: Yes
- Number of late resorptions: Yes - Fetal examinations:
- - External examinations: Yes: all per litter
- Soft tissue examinations: Yes: half per litter
- Skeletal examinations: Yes: half per litter
- Head examinations: Yes - Statistics:
- p level 0.05 (two tailed)
ANOVA and t test, as well as Kruskal-Wallis test + Mann-Whitney U test, when appropriate. - Historical control data:
- Not given
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:yes
Details on maternal toxic effects:
>= 500 ppm: reduced food consumption;
1200 ppm: reduced body weight gain, perioral wetness and encrustation, increase in rel. liver weight
(see table below)
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 100 ppm (nominal)
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- NOAEL
- Effect level:
- > 1 200 ppm (nominal)
- Basis for effect level:
- other: developmental toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
No statistically significant effects on any gestational parameters, incl. number of corpora lutea, number of total nonviable (early or late resorptions or dead fetusess) or viable implantations, percent pre- or postimplantation los, or sex ratio.
No significant differences in the incidences of any individual malformation, of malformations by category (external, visceral, or skeletal), or of total malformations. Dilated cerebral ventricles (most common obserevd malformation) were spontaneous in nature and occured at similar incidences in treated and exposed groups. No significant increase in incidences of individual external variations by category. Incidences of serveral skeletal and visceral variations were significantly increased. However, they showed no dose-response relationship.
Effect levels (fetuses)
- Remarks on result:
- other: no effects, see text above
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
Results:
Measured parameter |
Target Concentration [ppm] |
|||
0 |
100 |
500 |
1200 |
|
Body weight change in g, GD6-9 |
12.7+-5.4 |
9.3+-5.4 |
8.7+-6.8 |
2.3+-5.7** |
Body weight change in g, GD6-15 |
49.2+-7.0 |
48.3+-9.9 |
48.4+-7.2 |
38.6+-12.2** |
Feed consumption in g/animal day-1, GD6-15 |
27.2+-2.1 |
26.9+-2.1 |
25.3+-2.4* |
23.1+-2.5** |
Feed consumption, GD15-21 |
31.1+-2.9 |
32.4+-3.0 |
31.6+-2.5 |
31.1+-2.9 |
Pregnant/treated rats (n) |
23/25 |
23/25 |
22/25 |
25/25 |
Corpora lutea per dam |
17.1+-2.3 |
16.7+-3.0 |
16.9+-1.6 |
17.5+-1.4 |
Implantations per dam |
16.3+-1.7 |
15.2+-1.8 |
15.9+-1.4 |
16.0+-2.3 |
Live fetuses % |
96.4+-5.1 |
93.4+-9.0 |
96.5+-3.8 |
94.5+-5.3 |
Dead fetuses |
0.0+-0.0 |
0.0+-0.2 |
0.0+-0.0 |
0.0+-0.0 |
Early resorptions |
0.5+-0.8 |
0.9+-1.0 |
0.5+-0.6 |
0.8+-0.8 |
Late resorptions |
0.1+-0.3 |
0.0+-0.0 |
0.0+-0.0 |
0.0+-0.2 |
% live male fetuses per litter |
49.7+-10.7 |
49.5+-12.6 |
52.9+-12.4 |
49.5+-12.7 |
Live fetal body weight (male & female) in g |
5.5+-0.2 |
5.7+-0.2 |
5.6++-0.3 |
5.5+-0.3 |
Live male fetal body weight in g |
5.7+-0.2 |
5.8+-0.3 |
5.7+-0.3 |
5.6+-0.3 |
Live female fetal body weight in g |
5.4+-0.2 |
5.5+-0.2 |
5.4+-0.3 |
5.3+-0.3 |
Means +- standard deviation; 25 dams in each group;
Applicant's summary and conclusion
- Conclusions:
- Cumene showed no developmental toxicity in rats, as derived in a the test performed according to OECD 414. Thus the NOAEL for developmental toxicity was 1200 ppm, while the NOAEL for maternal toxicity was 100 ppm based on reduced food consumption.
- Executive summary:
Groups of 25 rats were exposed on GD 6 -15 to concentrations of 0 (control: filtered air), 100, 500 and 1200 ppm cumene. At 500 ppm and above reduced food consumption was observed. At the highest concentration maternal body weight gain was reduced and relative liver weight was increased. Furthermore, perioral wetness and encrustation were observed. None of the gestational parameters were affected. There were no treatment-related increase in incidences of external, visceral and skeletal malformations.
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