Registration Dossier

Administrative data

Endpoint:
in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
Remarks:
Type of genotoxicity: DNA damage and/or repair
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
The data source is the competent authority and it is considered reliable. Although not all the details on materials and results are provided, the test method is similar to official guideline methods.
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
Deviations:
yes
Remarks:
no positive control included
GLP compliance:
not specified
Type of assay:
micronucleus assay

Test material

Constituent 1
Chemical structure
Reference substance name:
1,1,2-trichloro-1,2-difluoroethane
EC Number:
940-543-9
Cas Number:
354-15-4
Molecular formula:
C2HCl3F2
IUPAC Name:
1,1,2-trichloro-1,2-difluoroethane
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): R122a

Test animals

Species:
mouse
Strain:
not specified
Sex:
not specified

Administration / exposure

Route of administration:
oral: unspecified
Duration of treatment / exposure:
2 single administrations.
Frequency of treatment:
Twice with the intervals of 24 hours.
Post exposure period:
24 hours
Doses / concentrationsopen allclose all
Remarks:
Doses / Concentrations:
780 mg/kg
Basis:
no data
Remarks:
Doses / Concentrations:
3900 mg/kg
Basis:
no data
No. of animals per sex per dose:
7
Control animals:
yes

Examinations

Tissues and cell types examined:
Erythrocytes of femoral bone marrow.

Results and discussion

Test results
Genotoxicity:
negative
Toxicity:
not examined
Negative controls validity:
valid
Positive controls validity:
not examined

Any other information on results incl. tables

Summary of Results

Studied dose

Number of animals

Polychromatocytes

 

 

Polychromatocytes analysed

Polychromatocytes with micronuclei Mav. ± M

% tst

Control

7

7,000

0.31±0.019

 

780 mg/kg

7

7,000

0.37±0.042

1.3

3,900 mg/kg

7

7,000

0.42±0.051

2.02

Applicant's summary and conclusion

Conclusions:
Under the test conditions of the reported study, HCFC 122a did not show mutagenic activity following oral administration to mice.
Executive summary:

The objective of the study was the assessment both of the reprotoxicity potential and of the genotoxicity potential of HCFC 122a. To this scope, an in vivo micronucleus test and an Ames test were performed.

 

The micronucleus test was conducted on white mice weighing 18-20 g.

HCFC 122a was administered to mice twice with the intervals of 24 hours, at doses of 1/2 and 1/10 of the LD50 = 7800 mg/Kg. The animals were sacrificed in 24 hours after the last administration.

Femoral bones were taken and the bone marrow was placed into a drop of group IV human serum inactivated at 56 °C for 2 hours and took a smear. After drying of preparations in air, the smear was consequently stained with Main-Grunwald and Giemsa stains.

Analysis of bone marrow smear was performed using the immersion microscope objective Jenaval (magnification H/100x12.5¥0.17-A). Preparations with well expanded erythrocytes, the surface of which did not have protuberances and folds were considered suitable for the analysis. 1000 polychromatocytes were counted per each animal.

HCFC 122a mutagenicity was assessed by the presence or absence of difference in the number of micronuclei between the experimental and control animals. Data are shown as a number of polychromatocytes containing micronuclei in percent. For the statistical evaluation, the original data for each animal were standardized according to the formula:

 

W = arc sin [(r+0.375)/(n+0.75)] 1/2

where r – number polychromatophils with micronuclei

           n – the total number of polychromatocytes,

and then used tst– Student’s t test.

 

The data obtained indicate that the incidence of micronuclei in the bone marrow cells of experimental mice for the studied doses was not statistically different from the control values.

Thus, the studied dosage range of HCFC 122a upon oral administration to mice in micronucleus test did not have mutagenic activity.