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EC number: 202-613-0 | CAS number: 97-86-9
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
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- Density
- Particle size distribution (Granulometry)
- Vapour pressure
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- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
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- Endpoint summary
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- 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
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- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
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- Genetic toxicity
- Carcinogenicity
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- Specific investigations
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- Additional toxicological data

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: see 'Remark'
- Remarks:
- DATA QUALITY: Study was conducted in accordance with a recognized scientific procedure for determining the adverse effects of a test substance in the Mouse Micronucleus Cytogenetic Assay following GLP regulations. Positive control used was one recognized and required in contemporary mutagenic assays; and also confirmed the sensitivity of the test procedure to detect an increase in micronuclei in vivo. The study meets national and international scientific standards and provides sufficient information to support the conclusions regarding the mutagenic findings demonstrated from the study data.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- Isobutyl methacrylate
- EC Number:
- 202-613-0
- EC Name:
- Isobutyl methacrylate
- Cas Number:
- 97-86-9
- Molecular formula:
- C8H14O2
- IUPAC Name:
- isobutyl methacrylate
Constituent 1
- Specific details on test material used for the study:
- Isobutylmethacrylate; 99.8% purity; colorless liquid.
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- NMRI Mice, 12 weeks old at initiation, males and females weighing approximately 30 grams; housed singly.
Administration / exposure
- Route of administration:
- oral: gavage
- Details on exposure:
- In a pre-experiment, 4 animals (2 m and 2 f) per dose received a single oral dose of 5000 mg/kg body weight
of the test material suspended in 1 % CMC (carboxymethylcellulose). A dose volume of 10 ml/kg was used. These
animals displayed toxic symptoms: apathy, reduced activity and closed eyelids.
In the full experiment, 6 males and 6 females were assigned to each test group (negative control, positive control
and test material), examined at 24, 48 and 72 hours post-treatment. A single dose of 5000 mg/kg was given orally. - Duration of treatment / exposure:
- single dose
Doses / concentrations
- Remarks:
- Doses / Concentrations:
5000 mg/kg (1 % in CMC Carboxymethycellulose)
Basis:
- No. of animals per sex per dose:
- six/sex/dose
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- Cyclophosphamide (CP): 40 mg/kg given orally as a single dose
Examinations
- Tissues and cell types examined:
- Tissues and Cells Examined:
femur bone marrow
Number of polychromatic erythrocytes (PCEs) examined per animal 1000
Number of normochromatic erythrocytes (NCEs) examined per animal 1000
Proportion of polychromatic erythrocytes to normochromatic erythrocytes, per 1000 PCEs. - Details of tissue and slide preparation:
- Sampling after 24, 48 and 72 hours.
positive control sampled after 48 hours.
Details of slide preparation: 24, 48, and 72 hrs after dose administration 5M/5/F per test article-treated and vehicle control groups are sacrificed by cervical dislocation. Positive control group was sacrificed 24 hrs after dosing, only. Immediately after sacrifice, femurs are exposed and bone marrow aspirated into a syringe containing fetal bovine serum and transferred to a centrifuge tube where the bone marrow cells are pelleted by centrifugation and the supernatant drawn off. Cells resuspended by aspiration with a capillary pipette and a small drop of the bone marrow suspension is spread onto a clean glass slide, air dried, fixed by dipping in methanol, and stained with May-Gruenwald-Giemsa. Note: an extra male and female mouse per dose was retained in case an animal died during the gavage process.
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Remarks:
- 2 males and 1 female died during the 48 hr assay period, and 1 female died during the 72 hr period.
- Positive controls validity:
- valid
- Additional information on results:
- Results from Pilot Toxicity Assay showed no mortality at 5000 mg/kg. Based upon these results the high dose
for the micronucleus test was set at 5000 mg/kg.
In the micronucleus test, 2 males and 1 female died during the 48 hr assay period, and 1 female died during the
72 hr period. The number of micronucleated PCEs per 1000 cells in test-article treated groups was not statistically
increased relative to the vehicle control in either sex, regardless of collection time. The positive control (CP)
induced a significant increase in micronucleated PCEs in both sexes. At 24 hours, the number of PCEs with
micronuclei was 0.09 % (vehicle), 0.13 % (test material), and 1.06 % (positive control). At 48 and 72 hrs the
results for vehicle versus test material were 0.14-0.09 % and 0.06-0.08 %, respectively. A cytotoxic effect was
evidenced by a reduction in number of polychromatic erythrocytes (PCE) in relation to the normochromatic
erythrocytes (NCE). A score of 1,000 PCE was determined for each animal revealing no indication for a genotoxic
activity of i-BMA in vivo.
Applicant's summary and conclusion
- Conclusions:
- The test material was negative (not clastogenic) in the micronucleus test using male and female NMRI mice.
- Executive summary:
In a valid guideline study, the test material was negative (not clastogenic) in the micronucleus test using male and female NMRI mice.
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