Registration Dossier

Administrative data

Endpoint:
health surveillance data
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
Mar 1992 - Jun 1992
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well documented study report which meets basic scientific principles

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Study type:
biological exposure monitoring
Endpoint addressed:
genetic toxicity
Principles of method if other than guideline:
cytogenetic analysis of sister chromatid exchanges in lymphocytes obtained from exposed workers.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): sodium salt of 2,4,-D acid

Method

Type of population:
occupational
Ethical approval:
not specified
Details on study design:
examined group:
8 male employees in section of 2,4-D acid production, aged 35-60 years (mean 48.5), duration of their employment: 15-39 years ( mean 26)
control group:
8 age-matched workers without exposure to 2,4-D acid

All participants were interviewed about demographic data, occupational history and life data that included smoking habit and other exposure to agents with known or suspected genotoxic activity.

Results and discussion

Results:
The difference between mean SCE frequency in the exposed and the control group was not statistically significant (α = 0.05)
In both groups, significant higher SCE frequencies were observed in lymphocytes of smokers.
These positive results for smokers demonstrate sufficient sensitivity of the used system.

Any other information on results incl. tables

Table 1a: Results of sister exchange frequency analysis in peripheral blood lymphocytes

of workers employed at production of 2,4-D acid of salt

Code No.

Age

(year)

Employment (year)

No. of cells

No. of SCE

Range SCE/cell

Mean SCE/cell

 ± SD

R/1*

60

39

50

373

4 – 14

7.46 ± 2.29

R/2*

60

29

50

421

3 – 18

8.42 ± 2.89

R/3*

49

29

50

440

4 – 14

8.80 ± 2.53

R/4*

44

25

50

442

4 – 20

8.84 ± 3.51

R/5

54

31

50

386

4 – 14

7.22 ± 2.95

R/6

42

22

50

372

3 – 12

7.44 ± 2.31

R/7

44

19

50

394

3 – 12

7.88 ± 2.45

R/8

35

15

50

410

4 – 14

8.20 ± 2.36

Mean

48.5

26

 

 

 

8.10 ± 0.56

* - smokers

Table 1b: Results of sister exchange frequency analysis in peripheral blood lymphocytes of control subjects

Code No.

Age

(year)

Employment (year)

No. of cells

No. of SCE

Range SCE/cell

Mean SCE/cell

 ± SD

Rk/1*

42

 

50

379

3 – 13

7.58 ± 2.70

Rk/2*

42

 

50

396

3 – 12

7.94 ± 2.14

Rk/3*

41

 

50

376

3 – 12

7.52 ± 2.20

Rk/4*

56

 

50

498

4 – 18

9.96 ± 3.23

Rk/5*

41

 

50

434

4 – 16

8.68 ± 2.46

Rk/6

63

 

50

349

3 – 13

6.98 ± 2.27

Rk/7

51

 

50

373

3 – 13

7.46 ± 2.68

Rk/8

39

 

50

384

3 – 15

7.68 ± 2.52

Mean

47.6

 

 

 

 

7.98 ± 0.94

* - smokers

The mean cell SCE/cell for

Smokers (n=9): 8.35 ± 0.82

Non-smokers (n=7): 7.62 ± 0.38

Applicant's summary and conclusion

Conclusions:
Occupational exposure to 2,4-D acid did not produce a genotoxic effect measured by sister chromatid exchanges (SCE) in lymphocytes of examined workers.