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Diss Factsheets

Toxicological information

Genetic toxicity: in vivo

Currently viewing:

Administrative data

Endpoint:
in vivo mammalian cell study: DNA damage and/or repair
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
GLP compliance:
yes
Type of assay:
mammalian erythrocyte micronucleus test

Test material

1
Chemical structure
Reference substance name:
1,3-dichloropropan-2-ol
EC Number:
202-491-9
EC Name:
1,3-dichloropropan-2-ol
Cas Number:
96-23-1
Molecular formula:
C3H6Cl2O
IUPAC Name:
1,3-dichloropropan-2-ol
Test material form:
liquid

Test animals

Species:
mouse
Strain:
CB6F1
Sex:
male
Details on test animals or test system and environmental conditions:
Age 8-10 weeks
body weight 20-35 g
supplier Taconic NIEHS colony
Food: Purina Certified 5002 Pelleted Diet, ad libitum

Housed singly
Temperature 18-26 celsius
relative humidity 30%
Light period 600-1800

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
0.9% saline
Details on exposure:
PREPARATION OF DOSING SOLUTIONS: prepared in 0.9 % saline
at 2.5mg/ml, 5 mg/ml and 10 mg/ml
Duration of treatment / exposure:
72 hours
Frequency of treatment:
single
Doses / concentrationsopen allclose all
Dose / conc.:
25 mg/kg bw/day (actual dose received)
Dose / conc.:
50 mg/kg bw/day (actual dose received)
Dose / conc.:
100 mg/kg bw/day (actual dose received)
No. of animals per sex per dose:
5 (five)
Control animals:
yes, concurrent vehicle
Positive control(s):
150 mg/kg ethyl methane sulfonate

Examinations

Tissues and cell types examined:
bone marrow erythrocytes

Results and discussion

Test results
Sex:
male
Genotoxicity:
negative
Toxicity:
no effects
Vehicle controls validity:
valid
Negative controls validity:
not applicable
Positive controls validity:
valid

Any other information on results incl. tables

Blood
Start Date Sample Collection Time Sex Methodology Used Route Dosing Regimen
23/09/2008 28 hour Male Flow Cytometry Gavage Gavage x 4, 4 day
  Dose Animal Polychromatic Erythrocytes Normochromatic Erythrocytes
(mg/kg) Number Trend P: 0.9057418632200795 Trend P: 0.5630751976468024
    No. Examined Total MN Cells Percent PCE MN Cells No. Examined Total MN Cells Percent NCE MN Cells
    per 1000 per 1000
Vehicle Control Saline  0          1 20000 62 1.4 3.1 1428487 2095 98.6 1.5
   0          2 20000 57 1.1 2.9 1724165 2304 98.9 1.3
   0          3 20000 49 1.3 2.5 1522067 2273 98.7 1.5
   0          4 20000 51 1.4 2.6 1389274 2125 98.6 1.5
   0          5 20000 54 1.2 2.7 1669659 2434 98.8 1.5
Average ± SEM   1.285 ± 0.053 2.730 ± 0.115   0.000 ± 0.000 1.457 ± 0.033
 
Test Chemical 1,3-Dichloro-2-propanol 25          10 20000 44 1.6 2.2 1201091 1817 98.4 1.5
  25          6 20000 52 1.4 2.6 1437928 2142 98.6 1.5
  25          7 20000 48 1.3 2.4 1576941 2422 98.7 1.5
  25          8 20000 40 1.3 2 1543362 2215 98.7 1.4
  25          9 20000 62 1.3 3.1 1482301 2267 98.7 1.5
Average ± SEM   1.375 ± 0.069 2.460 ± 0.189   0.000 ± 0.000 1.501 ± 0.018
Pairwise P   0.817   0.349
 
Test Chemical 1,3-Dichloro-2-propanol 50          11 20000 45 1.3 2.3 1549017 2174 98.7 1.4
  50          12 20623 41 1.2 2 1662551 2475 98.8 1.5
  50          13 20000 38 1.1 1.9 1769073 2455 98.9 1.4
  50          14 20000 49 1.3 2.5 1475861 2145 98.7 1.5
  50          15 20000 62 1.6 3.1 1222994 1825 98.4 1.5
Average ± SEM   1.313 ± 0.082 2.338 ± 0.214   0.000 ± 0.000 1.445 ± 0.021
Pairwise P   0.885   0.415
 
Test Chemical 1,3-Dichloro-2-propanol 100          16 20000 56 1 2.8 1903261 2781 99 1.5
  100          17 20000 37 1.1 1.9 1757290 2554 98.9 1.5
  100          18 20000 46 0.8 2.3 2494753 3909 99.2 1.6
  100          19 20000 61 0.8 3.1 2391448 3396 99.2 1.4
  100          20 20000 33 0.9 1.7 2220912 3186 99.1 1.4
Average ± SEM   0.936 ± 0.063 2.330 ± 0.268   0.000 ± 0.000 1.467 ± 0.026
Pairwise P   0.909   0.443
 
Positive Control Ethyl Methane Sulfonate 150          21 20000 177 1 8.9 2020359 3163 99 1.6
  150          22 20000 147 1.2 7.4 1637685 2642 98.8 1.6
  150          23 20000 235 1.1 11.8 1806498 3315 98.9 1.8
  150          24 20000 234 1.2 11.7 1718822 2967 98.8 1.7
  150          25 20000 203 1 10.2 1947659 3185 99 1.6
Average ± SEM   1.090 ± 0.042 9.960 ± 0.846   0.000 ± 0.000 1.675 ± 0.048
Pairwise P   0.005   0.003
 

Applicant's summary and conclusion

Conclusions:
1,3-dichloropropan-2-ol did not induce any micronuclei in the femur bone marrow of male B6C3F1 mice at 25-100 mg/kg bw when examined using the OECD 474 test guideline