Registration Dossier
Registration Dossier
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EC number: 205-769-8 | CAS number: 150-76-5
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / bone marrow chromosome aberration
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- no data
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: The test condition are equivalent to those of the EU test guideline. The test material is not clearly identified (purity unknown, chemical name of the compound not cited in the report).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.11 (Mutagenicity - In Vivo Mammalian Bone-Marrow Chromosome Aberration Test)
- Deviations:
- yes
- Remarks:
- Humidity 42-39% (instead of 50-60% recommended in the guideline), only 50 metaphasis analysed by animal (instead of 100 recommended in the guideline)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 475 (Mammalian Bone Marrow Chromosome Aberration Test)
- Deviations:
- yes
- Remarks:
- Humidity 42-39% (instead of 50-60% recommended in the guideline), only 50 metaphasis analysed by animal (instead of 100 recommended in the guideline)
- GLP compliance:
- yes
- Type of assay:
- chromosome aberration assay
Test material
- Reference substance name:
- W1188.01
- IUPAC Name:
- W1188.01
- Details on test material:
- Test material identifier: W1188.01, identified as 4-methoxyphenol in the letter to US EPA (into in the report).
Name of test material: W1188.01
Substance type: other: no data
physical state: solid
Analytical purity: data not available
impurities: data not available
lot/batch No: data not available
expiration date of the lot/batch: data not available
stability under test conditions: data not available
storage condition of test substance: room temperature
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Taconic Farms, Germantown, NY
- Age at study initiation: sexually mature (no more data)
- Weight at study initiation: 116-165 g
- Fasting period before study: no data
- Housing: individually in suspended wire mesh cages in the fourth floor toxicology facility.
- Food consumption (e.g. ad libitum): ad libitum
- Water consumption (e.g. ad libitum):ad libitum
- Acclimation period: 12 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22-24.3°C
- Humidity (%): 42-39%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light):12-hour light/dark
IN-LIFE DATES: data not available
On the day prior to dosing, the animals were divided into groups, 5 males and 5 females per group.
Administration / exposure
- Route of administration:
- oral: gavage
- Duration of treatment / exposure:
- once
Doses / concentrations
- Remarks:
- Doses / Concentrations:
100; 333; 1000 mg/kg bw
Basis:
Examinations
- Details of tissue and slide preparation:
- BONE MARROW RECOVERY: Bone marrow of both femure was aspirated into a prowerwed (37°C) Hank's balanced salt solution.
After centrifugation, cells were suspended in 0.075 M potassium chloride for 2-10 mn at 37°C. Carway's fixation was used. - Statistics:
- no data
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
Any other information on results incl. tables
No signs of toxicity were observed in the negative and positive control groups, the treated group at 6, 24, 48 hours in both males and females
except for two animals (105F and 114F) which were moribund after demonstrating signs of dyspnea and inactivity.
These animals were found dead in the morning of day 2.
In addition, one animal (111F) showed some dyspnea and inactivity on day 1 but recovered by day 2.
Applicant's summary and conclusion
- Conclusions:
For the chromosomal analyses, it would appear that the test substance (W1188.01) did not induce a significant increase in the number
of chromosomal aberrations despite some non-dose related variations among the groups.
Thus, this compound has no clastogenic potential under the conditions
tested.
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