Sodium 2,4-dichlorophenoxyacetate

Health surveillance data

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

Test material information

Constituent 1

Reference substance name:

Sodium 2,4-dichlorophenoxyacetate

EC Number:

220-290-4

EC Name:

Sodium 2,4-dichlorophenoxyacetate

Cas Number:

2702-72-9

Molecular formula:

C8H6Cl2O3.Na

IUPAC Name:

sodium 2-(2,4-dichlorophenoxy)acetate

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.