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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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: Recent study performed according to OECD 471 and GLP principals.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
Deviations:
no
GLP compliance:
yes
Type of assay:
micronucleus assay

Test material

Constituent 1
Reference substance name:
PMC D-532
IUPAC Name:
PMC D-532
Test material form:
other: waxy solid
Details on test material:
- Name of test material (as cited in study report): PMC D-532
- Physical state: Solid
- Analytical purity: 86.9% w/w
- Lot/batch No.: 30GT0982
- Expiration date of the lot/batch: 4.8.08
- Stability under test conditions: Stable
- Storage condition of test material: Ambient temperature in the dark

Test animals

Species:
mouse
Strain:
CD-1
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Breeding Laboratories, Margate, UK
- Age at study initiation: male and female 7-9 weeks of age for Phase I and male 10-11 weeks of age for phase II
- Weight at study initiation:
- Housing: mobile mouse cage racks
- Fasting period before study: no
- Diet: rat and mouse No. 1 maintenance diet (supplied by Special Diets Services, Stepfield, Witham, Essex, UK)
- Water: ad libitum
- acclimatisation period: 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25°C
- Humidity (%): 30-70%
- Air changes (per hr): 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
The control substance and vehicle for the test sample was dried corn oil (CTL test substance reference number Y00790/015).
Duration of treatment / exposure:
Single oral dose
Doses / concentrations
Remarks:
Doses / Concentrations:
2000 mg/kg
Basis:
actual ingested
No. of animals per sex per dose:
Male/Female: 5
Control animals:
yes
Positive control(s):
cyclohexylamine
- Doses / concentrations: 10 ml/kg bw

Examinations

Tissues and cell types examined:
polychromatic erythrocytes
Details of tissue and slide preparation:
CRITERIA FOR DOSE SELECTION:

TREATMENT AND SAMPLING TIMES ( in addition to information in specific fields):
The animals were killed by over-exposure to halothane followed by cervical dislocation 24 and 48 hours after receiving a single oral dose of the test substance. All animals treated with PMC D-532 were examined internally for signs of colouration or abnormalities to organs/tissues.

DETAILS OF SLIDE PREPARATION:
Femurs were removed and stripped clean of muscle. The iliac end of the femur was removed and a fine paint brush was rinsed in saline, wiped to remove the excess and wetted with a solution of albumin (6% w/v in physiological saline). This was then dipped into the marrow canal and two smears were painted on an appropriately labelled clean, dry microscope slide. This procedure was repeated to give four smears of marrow per slide. The slides were allowed to air dry and were stained with polychrome methylene blue and eosin using an automatic staining machine.

METHOD OF ANALYSIS:
Slides were coded and scored blind. Two thousand (2 x 1000) polychromatic erythrocytes were examined for the presence of micronuclei for each animal. The slides were also examined for evidence of cytotoxicity, which may be manifest by alterations in the ratio of different cell types in the bone marrow. This was assessed by counting the ratio of polychromatic to normochromatic erythrocytes in a sample of 1000 erythrocytes.

Results and discussion

Test results
Sex:
male/female
Genotoxicity:
negative
Toxicity:
no effects
Vehicle controls validity:
valid
Negative controls validity:
valid

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative
Under the conditions of test, PMC D-532 is not clastogenic in the mouse bone marrow micronucleus test.