Cocoa, ext.

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

No data

Reliability:

3 (not reliable)

Rationale for reliability incl. deficiencies:

other: Workers were exposed during the processing of cocoa, cacao, chocolate, almonds and nuts. Cocoa exposures were not quantified, and the role of cocoa in these results cannot be discerned

Data source

Reference

Reference Type:

publication

Title:

Respiratory symptoms and ventilatory function in confectionery workers

Author:

Zuskin E., Mustajbegovic J., Schachter E.N. and Kern J.

Year:

1994

Bibliographic source:

Occupational and Environmental Medicine 51, 435-439

Materials and methods

Principles of method if other than guideline:

Study conducted to investigate respiratory symptoms and ventilatory capacity in a group of 288 workers (259 women and 29 men) in a confectionary plant. Confectionary products included biscuits, sweets, chocolate, chewing gum candied fruits and snack products. Workers were grouped by specific exposures into five different groups. Group 3 (22 female workers) represented exposure to processing of nuts, almonds, cocoa, cacao and chocolate.

GLP compliance:

not specified

Test type:

other: Occupational and Environmental Medicine 51, 435-439

Test material

Test material information

Constituent 1

Reference substance name:

Cocoa powder

IUPAC Name:

Cocoa powder

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): cocoa
- Substance type: no data
- Physical state: solid
- Analytical purity: no data
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components: no data
- Isomers composition: no data
- Purity test date: no data
- Lot/batch No.: no data
- Expiration date of the lot/batch: no data
- Stability under test conditions: no data
- Storage condition of test material: no data

Test animals

Species:

other: Humans

Sex:

female

Administration / exposure

Details on inhalation exposure:

TYPE OF EXPOSURE: airborne

TYPE OF EXPOSURE MEASUREMENT: Area air sampling

EXPOSURE LEVELS: “total dust” concentration of 20 to 35.6 mg/m3, with a respirable fraction of “1.5-3.2 mg/m3”

EXPOSURE PERIOD: presumably about 8 hours/day, 5 days/week for an average of 9 years

POSTEXPOSURE PERIOD: workers were still employed at time of testing

DESCRIPTION / DELINEATION OF EXPOSURE GROUPS / CATEGORIES: individuals employed in areas processing nuts, almonds, cocoa, cacao and chocolate. Although workers occasionally moved to different working stations (with different exposures), they largely remained in one area

Duration of exposure:

ca. 8 h

Remarks on duration:

presumably about 8 hours/day, 5 days/week for an average of 9 years

Concentrations:

“total dust” concentration of 20 to 35.6 mg/m3, with a respirable fraction of “1.5-3.2 mg/m3”

Control animals:

other: 65 control female workers from a region of the plant not exposed to cocoa dust.

Details on study design:

HYPOTHESIS TESTED (if cohort or case control study): exposure to cocoa dust is linked with various acute and chronic respiratory and allergic symptoms, and eye and respiratory irritation

METHOD OF DATA COLLECTION
- Type: questionnaire (acute and chronic symptoms), clinical tests (ventilatory capacity)
- Details: chronic respiratory symptoms were recorded for confectionary and control workers using the British Medical Research Council questionnaire for respiratory disease, with additional questions on occupational asthma. Acute symptoms were also recorded, but not in controls. Please see “any other information on materials and methods incl. tables” for details on ventilatory capacity testing

STUDY PERIOD: no data

SETTING: confectionary plant in Zagreb, Croatia

STUDY POPULATION
- Total population (Total no. of persons in cohort from which the subjects were drawn): 288 workers (259 women and 29 men) (including many workers not working with cocoa or cocoa products). A control group of 127 workers comprised 96 women and 31 men that were not exposed to confectionary manufacture.
- Selection criteria: n/a
- Total number of subjects participating in study: 22
- Sex/age/race: Female/33/no data
- Smoker/nonsmoker: 15% of all female confectionary workers at the plant (a total of 259, only 22 of whom worked with nuts, almonds and cocoa and cocoa products)
- Total number of subjects at end of study: 22
- Matching criteria: n/a (study had no selection criteria)
- Other: individuals had been employed on average for 9 years

COMPARISON POPULATION
- Type: Control or reference group
- Details: 65 women of a similar age (average 31) and smoking habit, employed as transport workers in the same plant for an average of 10 years; 31 men employed in the same environment, with average age 36 and employed for an average of 8 years, may have been included as controls.

HEALTH EFFECTS STUDIED
- Disease(s): various symptoms (acute effects: cough, dyspnoea, throat burning or dryness, eye irritation, nose secretion, dryness or bleeding, headache; chronic effects: chronic cough or phlegm, chronic bronchitis, dyspnoea grades 3 and 4, occupational asthma, chest tightness, nasal catarrh, sinusitis)
- ICD No.: no data
- Year of ICD revision: no data
- Diagnostic procedure: no data
- Other health effects: ventilatory capacity

OTHER DESCRIPTIVE INFORMATION ABOUT STUDY: The following definitions were used for chronic respiratory symptoms:
Chronic cough or phlegm: “cough or phlegm production for at least three months a year”
Chronic bronchitis: “cough and phlegm for a minimum of three months a year and for not less than two successive years”
Dyspnoea grade 3: “shortness of breath when walking with other people at an ordinary pace on level ground”
Dyspnoea grade 4: “shortness of breath when walking at their own pace on level ground”
Occupational asthma: “recurring attacks of dyspnoea, chest tightness, and impairment of pulmonary function of the obstructive type associated with or after workshift”. Diagnosed by medical records.

Statistics:

Ventilatory capacity results were analysed by paired t-test (for across-shift changes, and comparing baseline to predicted normal values). The unpaired t-test measured differences between exposed and control workers. The chi-squared or Fishers exact test were used to detect differences in the prevalence of respiratory symptoms.

Differences between exposed and predicted values were significant for all parameters, with p < 0.01 for FVC and FEF50, and p < 0.05 for FEV1 and FEF25.

Results and discussion

Any other information on results incl. tables

EXPOSURE

- Number of measurements: 20 [five areas were assessed, including four where cocoa was not processed – possibly this value represents the number of measurements taken per area, or the total number of measurements taken for all five areas]

- Average concentrations: no data

  - Arithmetic mean: no data

  - Geometric mean: no data

  - Median: no data

  - 95-Percentile: no data

- Standard deviation: no data

- Date(s) of measurement(s): no data

- Other: the range was 20 to 35.6 mg/m³“total dust” (with cocoa content unknown), of which “15-3.2 mg/m³” was respirable [15 is probably a typo for 1.5]

 

FINDINGS: see “remarks on results including tables and figures”

Confounding factors

Workers were exposed to a number of different substances, notably dust from nuts and almonds, which could be responsible for the respiratory effects observed. Only total dust content was measured; cocoa exposure is unquantified

 

Acute symptoms:

Acute (across workshift) symptoms in 22 female confectionary workers processing cocoa (and/or cacao, chocolate, almonds and nuts) (numbers affected in brackets, apparently not compared to controls):

	22 confectionary workers
Cough	22.7% (5)
Dyspnoea	40.9% (9)
Throat burning	36.4% (8)
Throat dryness	81.8% (18)
Eye irritation	59.1% (13)
Nose secretion	18.2% (4)
Nose dryness	27.3% (6)
Nose bleeding	27.3% (6)
Headache	54.5% (12)

 

Chronic respiratory symptoms:

Chronic symptoms in 22 female confectionary workers processing cocoa (and/or cacao, chocolate, almonds and nuts) (numbers affected in brackets):

	22 female confectionary workers	65 unexposed control women	31 unexposed control men
Chronic cough	9%** (2)	6.2% (4)	19.4% (6)
Chronic phlegm	9% (2)	3.1% (2)	16.1% (5)
Chronic bronchitis	9% (2)	3.1% (2)	16.1% (5)
Dyspnoea grade 3 and 4	13.6% (3)	0% (0)	2.5% (2)
Occupational asthma	4.5% (1)	0% (0)	0% (0)
Chest tightness	45.4%** (10)	0% (0)	0% (0)
Nasal catarrh	13.6%* (3)	1.5% (1)	0% (0)
Sinusitis	31.6%** (7)	1.5% (1)	0% (0)

 

* Statistically significant (p < 0.05)

** Statistically significant (p < 0.01) [this could be in error for the cough figures; the double asterisk should probably be against the dyspnoea incidence]

 

It is not clear whether the results for the exposed workers were compared to those for control women or control men and women (but the former seems more likely).

 

Ventilatory capacity:

Ventilatory capacity in 22 female confectionary workers processing cocoa (and/or cacao, chocolate, almonds and nuts), before, and after a daytime shift:

FVC	Before shift (L)	3.62
	Difference after shift (%)	-2.2**
FEV1	Before shift (L)	2.91
	Difference after shift (%)	-2.4*
FEF50	Before shift (L)	3.64
	Difference after shift (%)	-8.8**
FEF25	Before shift (L)	2.30
	Difference after shift (%)	-14.7**

 

* Statistically significant (p < 0.05)

** Statistically significant (p < 0.01)

 

The before-shift baseline ventilatory capacity was compared to predicted and control values.

 

Differences between exposed and predicted values were significant for all parameters, with p < 0.01 for FVC and FEF₅₀, and p < 0.05 for FEV₁and FEF₂₅.

 

Baseline FVC, FEV₁, FEF₅₀and FEF₂₅were 91.3, 90.3, 72.4 and 83.5% of values for control individuals, respectively [but significance was apparently not assessed].

 

It appears that the results for the exposed women were compared to those for control women rather than control men and women, but this is not entirely clear.

 

Applicant's summary and conclusion

Conclusions:

Working in an environment containing high levels of total dust (including an unspecified amount of cocoa) of 20 to 35.6 mg/m3 was linked to a significantly increased incidence of a number of chronic respiratory symptoms, and significant acute and chronic reductions in ventilatory capacity in some workers following long-term exposure (ave 10years).
The effects of cocoa cannot be assessed from these results (as individuals were also exposed to almonds and nuts etc.), and cocoa exposure levels were not calculated. These results do, however, suggest that occupational exposure to high airborne concentrations of cocoa and/or other organic dusts may be linked to chronic and acute respiratory symptoms and reductions in ventilatory capacity

Executive summary:

A number of health effects were assessed in 22 female confectionary workers occupationally exposed to cocoa, cacao and chocolate (as well as nuts and almonds). Total dust levels (including an unspecified amount of cocoa) were 20 to 35.6 mg/m³, of which “15-3.2 mg/m³” [possibly 1.5-3.2 mg/m³] was respirable. On average, workers had been employed at the plant for 9 years.

 

A questionnaire was used to assess the presence of chronic respiratory symptoms (chronic cough, phlegm and bronchitis, nasal catarrh, sinusitis, chest tightness, shortness of breath (dyspnoea grades 3 and 4), and occupational asthma) in exposed workers, and in 65 control female workers from a region of the plant not exposed to cocoa dust. Acute symptoms (including cough, headache and eye and throat irritation) were assessed only in exposed workers (i.e. the significance of results could not be assessed), with high incidences reported e.g. for throat dryness (81.8%) and eye irritation (59.1%). For chronic respiratory symptoms, incidence of chest tightness, nasal catarrh, sinusitis and [probably] dyspnoea was significantly higher in exposed workers, compared to controls. No link with occupational asthma was identified.

 

Clinical testing was used to assess the ventilatory capacity of the 22 exposed workers, before and after a Monday daytime shift. Forced vital capacity (FVC), 1-second forced expiratory volume (FEV₁) and maximum flow rates at 50% and the last 25% of the control vital capacity (FEF₅₀and FEF₂₅) were measured. Results were compared to those seen for controls, and to predicted population values. Significant reductions in ventilatory capacity were seen after the work shift. Baseline (pre-shift) values were all significantly reduced compared to control values.

 

The before-shift baseline ventilatory capacity was compared to predicted and control values. Differences between exposed and predicted values were significant for all parameters. Parameters in exposed workers were reduced relative to control workers, but significance was apparently not assessed.

 

The effects of cocoa cannot be assessed from these results (as individuals were also exposed to almonds and nuts etc.), and cocoa exposure levels were not calculated. These results do, however, suggest that occupational exposure to cocoa might be linked to chronic and acute respiratory symptoms and reductions in ventilatory capacity.