Registration Dossier

Administrative data

Endpoint:
health surveillance data
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
According to SCOEL, this study has some shortcomings, as only 20 workers were examined, it is not clear whether the exposure was only to phenol and how the exposure was measured. Phenol is a major component of the reaction mass, so that phenol hazard data are applied in the hazard assessment.

Data source

Reference
Reference Type:
publication
Title:
Study of some biochemical changes among workers occupationally exposed to phenol, alone or in combination with other organic solvents
Author:
Shamy YM, El Gazzar RM, El Sayed MA and Attia AM
Year:
1994
Bibliographic source:
Ind Health 32: 207- 214

Materials and methods

Study type:
health record from industry
Endpoint addressed:
repeated dose toxicity: inhalation
Principles of method if other than guideline:
Hematologic and clinical chemistry parameters were examined as well as an urine analysis performed in workers exposed to phenol.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
No details

Method

Type of population:
occupational
Ethical approval:
not specified
Details on study design:
Subjects from an oil refining plant located in the city of Alexandria (Egypt) were selected randomly and have been divided into three groups:
Group I: Twenty workers (mean age +-SD: 35.2+-3.7 years) exposed to phenol alone (during aromatic extraction from distillates containing aromatics, wax, oil and impurities). The time weighted average exposure according to the factory records was 5.4 ppm (21 mg/m3). The mean duration of exposure (+-SD) was 13.2+-6.6 years. No further data on exposure were available.
Group II: Thirty subsjects in the reference group (mean age +-SD: 37.3+-3.6 years) selected from the administrative departments (located in a separate building, no exposure, no history of exposure to organic solvents); these subjects had the same demographic characters like age, educational and socioeconomic status ... etc, as workers in Group I.
In Group III workers with combined exposure to phenol, benzene, toluene and methyl ethyl ketone (MEK) (n = 32) were studied (not presented in this documentation); exposure according to factory records was 4.7 ppm for phenol, 0.7 ppm for benzene, 220 ppm for toluene. and 90 ppm for MEK.

Fasting blood samples were collected from each subject by vein puncture at the end of the shift of the last working day of the week. A part of the blood was centrifuged and the serum was separated for the analysis of transaminases, total proteins, prothrombin time, bleeding time, clotting time, fasting blood sugar (FES) and serum creatinine (see also Table below). Serum copper (Cu), zinc (Zn), iron (Fe), magnesium (Mg), manganese (Mn) and calcium (Ca) was determined by atomic absorption spectrophotometry.
The other part of the blood was used for haematology (red & white blood cell counts, haemoglobin, haematocrit, platelets, colour index, MCH, MCV, MCHC, basophils, eosinophils, neutrophils, monocytes, lymphocytes).
Spot urine sampies obtained from each subject for the determination of the levels of urinary phenol (concentration referred to the creatinine content).
Statistical analysis carried out using the one way ANOVA and the Scheffe test (*: level of significance at 5%; **: 1%).

Results and discussion

Results:
Workers exposed to phenol alone (Group I) at 21 mg/m3 showed significantly higher levels of ALT (alanine aminotransferase), AST (aspartic aminotransferase) and clotting time, and lower levels of serum creatinine as well as significantly higher serum levels of Mg, Mn and Ca than the control subjects. Further more, these workers showed significantly higher levels of haemoglobin, haematocrit, colour index, MCH, MCV, basophils and neutrophils and lower levels of monocytes than the control subjects. Urinary phenol concentrations in Group I was significantly elevated in comparison to the background levels in the nonexposed control group.

Any other information on results incl. tables

Phenol concentration in urine

 Parameter

 Workers exposed to phenol (n=20)  Reference group (n=30)

Phenol in urine

(mg/g creatinine)

 68.60 +- 47.06**

 11.54 +- 4.70

Effects of phenol inhalation on clinical chemistry and haematological parameters in humans

Parameter

Group I
phenol exposure (n=20)

Group II
controls (n=30)

-

Clinical chemistry

ALT (U/ml)

24.50+- 4.11*

15.81+- 14.92

AST (U/ml)

27.06+-16.87**

14.71+- 10.70

Serum creatinine (mg/dl)

0.85+- 0.20**

0.99+- 0.20

Clotting time (min)

6.13+- 0.82**

4.06+- 0.46

Serum magnesium (µg/dl) ,

2.3+- 0.5**

1.9+- 0.5

Serum manganese (mg/dl)

0.4+- 0..3**

0.2+- 0.3

Serum calcium (mg/dl)

11.9+- 2.0**

9.8+- 0.9

-

Haematology

Hemoglobin (g%)

14.6+-1.9*

13.7+- 1.4

Hematocrit (%)

45.1+- 5.6**

39.0+- 10.5

Color index (%)

1.1+- 0.1**

1.0+- 0.4

MCH (pg)

31.3+- 3.5**

29.4+- 1.1

MCV (fl)

96.7+- 10.4*

88.5+- 4.5

Basophils (%) .

0.5+- 0.5*

0.1+-0.3

Neutrophils (%)

64.4+- 5.4*

59.0+- 7.8

Monocytes· (%)

1.0+-1.1**

2.4+- 0.9

Mean +- SD (standard deviation); *:p<0.05; ** p<0.01

Other measured parameters (compare with methods) were not different from control value.

Applicant's summary and conclusion

Conclusions:
Workers exposed to a time weighted average of 5.4 ppm phenol (21 mg/m³) showed significantly altered parameters in clinical chemistry and haematology along with a significantly increased amount of phenol excreted via the urine.
Executive summary:

The study meets scientific standards with acceptable restrictions (partly limited documentation, e.g. details on exposure & exposure measurement; no individual data; no data on historical control range of clinical and haematological parameters in Egypt).

Twenty workers were exposed to phenol alone; the time weighted average exposure was 5.4 ppm (21 mg/m³) and the mean duration of exposure was 13.2 +-6.6 (SD) years. The reference group (n=30) had the same demographic characters like age, educational status and socioeconomic status. Fasting blood samples were collected from each subject at the end of the shift of the last working day of the week and haematology and clinical chemistry performed. Phenol concentration was analysed in urine samples of each subject and significantly increased concentrations were detected in exposed workers. Furthermore, in this group significantly higher levels of alanine aminotransferase, aspartic aminotransferase and clotting time, and lower levels of serum creatinine as well as significantly higher serum levels of Mg, Mn and Ca were reported. Haematology revealed significantly higher levels of haemoglobin, hematocrite, colour index, MCH, MCV, basophils and neutrophils and lower levels of monocytes in exposed workers.

Conclusion: Workers exposed to a time weighted average of 5.4 ppm phenol (21 mg/m³) showed significantly altered parameters in clinical chemistry and haematology along with a significantly increased amount of phenol excreted via the urine.