Registration Dossier

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:
1986
Report Date:
1986

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
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:
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
Name:
Unnamed
Type:
Constituent
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

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals 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:
Interpretation of results (migrated information): negative
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.