Silver docosanoate

Direct observations: clinical cases, poisoning incidents and other

Administrative data

Endpoint:

direct observations: clinical cases, poisoning incidents and other

Type of information:

other: clinical case study

Adequacy of study:

weight of evidence

Reliability:

other: Reliability was not assessed, because the publication was considered acceptable due to the fact that it served as a basis for OEL setting.

Data source

Reference

Reference Type:

publication

Title:

Osservazione di quattro casi di argirosi professionale.

Author:

Perrone, S.; et al.

Year:

1977

Bibliographic source:

Med. Lavoro 68, n.3, 178-186

Materials and methods

Study type:

clinical case study

Endpoint addressed:

repeated dose toxicity: inhalation

Principles of method if other than guideline:

Four cases of argyria of the eye were examined in silver polishers. Attention is drawn to the early appearance of eye alterations and the clinical data of the subjects are considered.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

clinical case study

IUPAC Name:

clinical case study

Details on test material:

no information availble

Method

Type of population:

occupational

Subjects:

- Number of subjects exposed: 4
- Sex: male
- Age: 46- 61 years
- Smoking habit: 2 grade I smokers (4 cigarettes/day) and two class II smokers (20 cigarettes/day)

Ethical approval:

not applicable

Route of exposure:

inhalation

Reason of exposure:

intentional, occupational

Exposure assessment:

measured

Details on exposure:

Total dust: 0.31 mg/m3
Respirable dust: 0.022 mg/m3

Remark from OEL document: "it is douptful whether these concentrations are representative of actual exposure concentrations, because only one sample was taken at a location not identical with the exposure place of the 4 observed argyria cases.

Examinations:

- Urine analysis: Yes
- Haematology: No
- Lung function parameters: Yes
- Other: clinical examination, ECG, liver function, chest autoradiography, dermatological and occular inspections

Medical treatment:

No

Results and discussion

Clinical signs:

- Signs of local argyrosis resulting from direct contact with the metal were seen in structures of the eyes (conjunctiva, Descement's membrane and lacrimal caruncle) of all subjects.
- No effects on vision were observed by examination of an oculist.
- No macroscopic visible signs of silver deposition were observed in the skin, and skin biopsies revealed negative results.

Results of examinations:

Urine analysis:
- In one case, renal creatinine clearance was only moderately reduced and clearance of urea was reduced by 40%.

Lung function parameters:
- Restrictive emphysematous syndrome (reduction of pulmonary volume and increased residual volume) was seen in two cases who exhibited a tobacco smoking habit equivalent to 20 cigarettes per day, but not in the other two cases (4 cigarettes/day).
- Slight change in CO transfer in steady state was observed in 3 examined subjects.
- Chest x-ray examinations did not reveal findings of pneumoconiosis (from mixed dust), but revealed diffuse hyper transparency in two cases and accentuation of pulmonary trauma.

Other:
- Hepatic function was within the normal limits in all cases.
- Hepatomegaly was observed in one case in which malignant neoplasia was found.

Applicant's summary and conclusion

Conclusions:

For cases of argyria of the eye were examined in silver polishers. The data show that occupational inhalation and direct contact with silver dusts caused local effects on skin and eyes. However, an association between increased intensity of pulmonary trauma, a restrictive emphysematous syndorm and slight changes in CO transfer with silver dust exposure could not be ruled out.