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Environmental and Workplace Health

Priority Substances List Assessment Report for Ethylene Oxide

2.0 Summary of Information Critical to Assessment of "Toxic" under CEPA 1999

2.4.4.2 Cancer

Table 4 Cytogenetic effects in humans (modified from IARC, 1994)

Number exposed
(number of controls)

Exposure time (years)

Ethylene oxide level
in air (ppm) 1

Cytogenetic
observations 2

Reference

Range

Mean

Range

Mean (TWA)

CA

SCE

MN

75 (0)

 

 

 

≤ 50

+

+

 

Abrahams (1980)

33 (0)

1-14

 

≤0.05-8

≤0.01 3

(+)

 

 

Clare et al. (1985)

13 (site I)
22 (site II)
25-26 (site III)

(171 controls total)

 

 

0.5 4
5-10 4
5-20 4

 

-

-

+

-

+

+

 

Stolley et al. (1984);
Galloway et al. (1986)

12 (12)

 

 

≤36

 

 

+

 

Garry et al. (1979)

14 (14)

 

 

<0.07-
4.3 4

 

 

-

 

Hansen et al. (1984)

18 (factory I)
10 (factory II)

(20 controls total)

0.5-8

0.5-8

3.2

1.7

 

<1

<1

+

+

-

-

+5

Hogstedt et al. (1983)

18 (sterilization centres) (10)

14 (laboratory - 1983) (10)

11 (laboratory - 1984) (10)

21 (production workers) (20)

1-8

1-15

1-15

2-17

 

0-2,6

0-4

0-2,3

0-3.7

 

+

+

-

+

 

 

Karelová et al. (1987)

15 (smokers) (7)

10 (non-smokers) (15)

0.5-10

0.5-10

5.7

4.5

20-123

20-123

 

 

+

+

 

Laurent et al. (1984)

10 (10)

 

3

60-69 4

 

+

+

 

Lerda et Rizzi (1992)

9 (low dose) (48)

27 (high dose) (10)

 

4

15

2.7-10.9

2.7-82

2.7

5.5

+

+

-

+

 

Major et al. (1996)

34 (23)

 

8 6

<0.1-
2.4 4

<0.3

-

+

-

Mayer et al. (1991)

12

5

(11 controls total)

1-8

0.8-3

4

1.6

0.5-1

5-10

 

-

+

 

 

Pero et al. (1981)

11 (smokers)

14 (non-smokers)
(10 controls total)

 

 

0.5-4177

0.5-208 7

 

 

-

-

 

Popp et al. (1994)

75 (22)

3-14

7

2-5 4

 

+

 

+

Ribeiro et al. (1994)

56 (141)

1-10

1-40 4

 

 

+

+

 

Richmond et al. (1985)

22 (22)

19 (19)

0.6-4

1.5-15

3

6.8

0.2-0.5 4

3,7-20 4

0.35

10.7

(+)

+

+

+

 

Sarto et al. (1984)

10 (10)

 

 

0-9.3 4

1.84

 

+

 

Sarto et al. (1987)

9 (27 controls total)

3

0.5-12

5

0.025-0.38 4

>0.38 8

 

 

 

-

+9

Sarto et al. (1990)

5 (10 controls total)

5

0.1-4

4-12

2

8.,6

<1-4,4

0.025

0.38

+

-

- 10

- 10

Sarto et al. (1991)

32 (8 controls total)

11

 

5.1

9.5

0-0.3 4

0.13-0.3 4

0.04

0.16

 

+

+

-

-

Schulte et al. (1992)

9 (hospital workers) (8)

15 (factory workers) (15)

2-6

3-27

4

12

20-25

17-33

 

+

+

+

+

-

+

Tates et al. (1991)

7 (7 controls total)

7

7

Accidental

<5

>15

 

28-429 4

<0.005-0.02

<0.005-0.01

 

 

-

-

-

-

-

-

Tates et al. (1995)

9 (low exposure)
5 (high exposure)

(13 controls total)

 

 

 

13 11
501 11

 

-

+

 

Yager et al. (1983)

19 (35 controls total)
17

1-5

6-14

 

<0.05-8

<0.05-8

<0.05

<0.05

-

-

 

 

van Sittert et al. (1985)



1 1 ppm = 1.83 mg ethylene oxide/m3.

2 CA = chromosomal aberrations; SCE = sister chromatid exchange; MN = micronucleus.

3 Calculated by linear extrapolation.

4 TWA (8-hour).

5 Positive for erythroblasts and polychromatic erythrocytes (negative for lymphocytes).

6 Maximum years exposed.

7 Peak concentrations.

8 Exposed acutely from sterilizer leakage in addition to chronic exposure.

9 Nasal mucosa.

10 Buccal cells.

11 Average 6-month cumulative exposure (mg).

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