Man-made vitreous (silicate) fibres with random orientation with alkaline and alkali earth oxides (Na2O+K2O+CaO+ MgO+BaO) content greater than 18% by weight and fulfilling one of the CLP Regulation Annex VI Note Q conditions

Direct observations: clinical cases, poisoning incidents and other

Administrative data

Endpoint:

direct observations: clinical cases, poisoning incidents and other

Type of information:

experimental study

Adequacy of study:

disregarded due to major methodological deficiencies

Reliability:

3 (not reliable)

Rationale for reliability incl. deficiencies:

significant methodological deficiencies

Data source

Reference

Reference Type:

publication

Title:

Foreign body granuloma of the penis caused by occupational glass fibre exposure

Author:

Hinnen U. et al.

Year:

1997

Bibliographic source:

Genitourin Med 73, 577-578

Materials and methods

Study type:

other: case report

Endpoint addressed:

toxicity to reproduction / fertility

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

- Short description of test conditions: Case report of a 53-year old male patient diagnosed with penile ulcer (granuloma) following foreign body reaction from dermal exposure (job exposure to fibre-reinforced plastic product manufacturing factory for 4 years) to glass fibre.
- Parameters analysed / observed: clinical findings by biopsy and serology, occupational exposure of glass fibres

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Reference substance 001

Test material form:

solid: fibres

Method

Type of population:

occupational

Subjects:

- Number of subjects exposed: 1 (case report)
- Sex: male
- Age: 53
- Race: not specified
- Demographic information: not specified
- Known diseases: stage 1 syphilis (treated in the 1960s)

Ethical approval:

not specified

Route of exposure:

dermal

Reason of exposure:

unintentional, occupational

Exposure assessment:

estimated

Details on exposure:

The patient started a new job 4 years before the examination in a factory manufacturing fibre reinforced plastic products. He spend most of his working time cutting up glass fibre mats before they were used for lamination in another part of the plant. During this activity he was heavily exposed to glass fibres that were released in the air and deposited on his clothes and skin. On the occasion of a visit to the workplace glass fibres were also identified on the inner side of his underpants although he was trying to stop penetration by wearing especially close trousers underneath his overall at the time of the visit.

Examinations:

- Urine analysis: not determined
- Haematology: not determined
- Lung function parameters: not determined
- Other: serology (infection of VDRL, TPHA, FTA, Chlamydia trachomatis, HIV testing), biopsy of a tissue specimen, general examination of the skin

Medical treatment:

Because of his history of stage 1 syphilis and the ulcer he was treated by his physician with two shots of benzathine penicillin (2 x 4 million units) intramusculary.

Results and discussion

Results of examinations:

- Urine analysis: not determined
- Haematology: not determined
- Lung function parameters: not determined
- Other:
- Serology: VDRL negative, TPHA slightly positive (1:160), FTA Abs positive. This remained unchanged when repeated 2 months later, Chlamydia trachomatis: negative, HIV: negative
- Clinical findings: stage 1 syphilis, penile ulvers, scarring phimosis; at the time the patient was referred to the clinic two indurated, non-ulcerated plaues were present on the penis and small mobile inguinal lymph nodes were palpable bilaterally.
- Histopathology: The biopsy of one of the plaques showed a diffuse and pericascular inflammatory infiltrate, consisting mainly of plasma cells. In addition, granulomas were found with degenerative changes at the centre of the lesion and epithelioid as well as giant cells at the periphery. Within the forein granulomas no foreign bodies were observed. An elognated birefractive structure possibly corresponding to a glass fibre was identified in the stratum corneum. This finding was consistant with an inflammatory reaction in late phase syphilis, but also with a granulomatous foreign body reaction.
- Examination of the skin: The general examination of the skin was normal

Effectivity of medical treatment:

The treatment of benzathine penicillin (2 x 4 million units) did not heal the penile ulcers.

Outcome of incidence:

After the patient had been circumcised the lesion healed within a few months, he developed no new lesions despite unchanged exposure. It has been proposed that the lesions only appeared as long as fibres were deposited between glans and prepuce, where they easily penetrated the moist, occluded skin, and disappeared afte the prepuce had been removed. Although the clinical appearance and the histological findings do not allow the possibility of a gumma (with coincidental glass fibre in the stratum corneum) to be completely ruled out, serology strongly argues against it, since only the specific tests (TPHA, FTA Abs) were slightly positive, while the VDRL was negative at control and 2 months later. The same is true for Chlamydia trachomatis infection (lymphogranuloma venereum). Donovanosis was ruled out too since the patient has not been in tropical/subtropical countries and also did not have any relations with anyone who had lived there.

Applicant's summary and conclusion

Conclusions:

In this case report, the exposure of glass fibres is assumed to cause inflammation with granuloma formation and a penile ulcer following a foreign body reaction. However the link between this penile granuloma and the occupational exposure to glass fibres could not have been clearly identified during the study and the lack of other cases greatly decreases the robustness of the study. Anyway, it is not possible to extrapolate based on only one observation.

Executive summary:

In a case report from Hinnen et al. (1997), a 53-year old patient was presented with a suspected diagnose of syphilis. Since a penile ulcer was observed and did not heal after treatment with benzathine penicillin, the patient was surgically treated and a tissue specimen was examined histologically. Furthermore, serology was conducted for active diseases and the skin was examined generally.

In the histopathological observation, a birefractory structure was observed in the biopsy possibly corresponding to a foreign body. Thus, the patient’s occupational exposure was investigated. Working in the fibre reinforced plastics industry, he was exposed to glass fibre that was even detected on the inside of his underwear. The serological pattern was not consistent with active syphilis and a penile ulcer following a foreign body reaction was diagnosed. Thus, the authors concluded that occupational exposure of glass fibres may cause genital granulomatous lesions, which could be misdiagnosed with sexually transmitted diseases.

However, the lack of other cases greatly decreases the robustness of the study. Anyway, it is not possible to extrapolate based on only one observation.