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EC number: 202-704-5 | CAS number: 98-82-8
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- Ecotoxicological Summary
- Aquatic toxicity
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- Short-term toxicity to fish
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- Long-term toxicity to aquatic invertebrates
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Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study performed according to guideline standards in context of the National Toxicology Program with detailed decription
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- GLP compliance:
- yes
- Remarks:
- Batelle Toxicology Northwest (Richland, WA)
- Type of assay:
- micronucleus assay
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
- Substance type:
- Physical state: colorless liquid with a sharp, penetrating, aromatic odour
- Analytical purity: 99.9% peak area
- Impurities (identity and concentrations): No impurities >0.05% peak area detected
- Purity test date: Not specified
- Lot/batch No.: Lot 200556852
- Expiration date of the lot/batch: No data
- Stability under test conditions: stable over the test period, no degradation of bulk chemical was detected
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- B6C3F1
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Taconic Laboratory Animals and Services (Germantown, NY)
- Age at study initiation: approx. 6 weeks old on first day of study
- Weight at study initiation: 19.0+/-0.2 to 23.4 +/- 0.3 g
- Fasting period before study:
- Housing: individually
- Diet (e.g. ad libitum): NTP-2000 irradiated pelleted diet (Zeigler Brothers, Inc, Gardeners, PA); changed weekly
- Water (e.g. ad libitum): Tap water (Richland, WA, muncipal supply) via automatic watering system (Edstrom Industries, Waterford, WI)
- Acclimation period: 11 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 24 +/- 2 (75 +/- 2° F)
- Humidity (%): 55 +/- 15
- Air changes (per hr): 15 +/- 2
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- inhalation: gas
- Vehicle:
- - Vehicle(s)/solvent(s) used: unchanged (no vehicle)
- Duration of treatment / exposure:
- 6 h plus T90 (=12 min)
- Frequency of treatment:
- 5 days per week (excluding holidays) for 14 weeks
- Post exposure period:
- none
Doses / concentrations
- Remarks:
- Doses / Concentrations:
62.5, 125, 250, 500, and 1000 ppm
Basis:
nominal conc.
- No. of animals per sex per dose:
- 9-10
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- none
Examinations
- Tissues and cell types examined:
- blood smears from peripherial blood.
- Details of tissue and slide preparation:
- Smears were immediately prepared and fixed in absolute methanol.
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- not examined
- Additional information on results:
- No increase in micronucleated erythrocytes was observed in peripheral blood of male or female mice exposed to cumene by inhalation (62.5 to 1,000 ppm) for 3 months. For both male and female mice, no significant changes in the percentage of PCEs were observed over the exposure range tested, indicating an absence of treatment-related toxicity to the bone marrow.
RESULTS OF DEFINITIVE STUDY
- Induction of micronuclei (for Micronucleus assay): see table below
- Ratio of PCE/NCE (for Micronucleus assay): see table below
- Statistical evaluation: see table below
Any other information on results incl. tables
Frequency of Micronuclei in Peripheral Blood Erythrocytes of Mice Following Treatment with Cumene by Inhalation for 3 Months[a]
Compound |
Dose (ppm) |
Number of male rats with erythrocytes scored |
Micronucleated PCEs/ 1000 PCEs [b] |
Pairwise P value [c] |
PCE [b] (%) |
Male |
|||||
Air [d] |
0 |
10 |
2.40 ± 0.69 |
2.7 ± 0.1 |
|
Cumene |
62.5 |
10 |
2.20 ± 0.66 |
0.6161 |
2.6 ± 0.1 |
125 |
10 |
2.10 ± 0.48 |
0.6728 |
2.6 ± 0.1 |
|
250 |
10 |
1.80 ± 0.36 |
0.8230 |
2.8 ± 0.1 |
|
500 |
10 |
2.00 ± 0.26 |
0.7270 |
2.9 ± 0.1 |
|
1,000 |
10 |
2.20 ± 0.42 |
0.6161 |
2.9 ± 0.2 |
|
P=0.553 [e] |
|||||
Female |
|||||
Air |
0 |
10 |
2.30 ± 0.40 |
3.3 ± 0.1 |
|
Cumene |
62.5 |
9 |
1.33 ± 0.37 |
0.9396 |
2.3 ± 0.1 |
125 |
10 |
1.70 ± 0.30 |
0.8289 |
3.1 ± 0.2 |
|
250 |
10 |
2.10 ± 0.53 |
0.6186 |
3.3 ± 0.2 |
|
500 |
10 |
2.10 ± 0.35 |
0.6186 |
3.4 ± 0.1 |
|
P=0.329 |
[a] Study was performed at ILS, Inc. The detailed protocol is presented by MacGregor et al. (1990).
NCE=normochromatic erythrocyte; PCE=polychromatic erythrocyte
[b] Mean ± standard error
[c] Pairwise comparison with the chamber controls, significant at P#0.025 (PCEs) or P#0.005 (NCEs) (ILS, 1990)
[d] Chamber control
[e] Significance of micronucleated NCEs/1,000 NCEs tested by the one-tailed trend test, significant at P#0.025 (ILS, 1990)
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
No increase in micronucleated erythrocytes was observed in peripheral blood of male or female mice exposed to cumene by inhalation for 3 months. - Executive summary:
- No increase in micronucleated erythrocytes was observed in peripheral blood of male or female mice exposed to cumene by inhalation (62.5 to 1,000 ppm) for 3 months. For both male and female mice, no significant changes in the percentage of PCEs were observed over the exposure range tested, indicating an absence of treatment-related toxicity to the bone marrow.
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