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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Direct observations: clinical cases, poisoning incidents and other

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Administrative data

Endpoint:
direct observations: clinical cases, poisoning incidents and other
Type of information:
other: occupational surveillance report
Adequacy of study:
supporting study
Study period:
November 1967 / December 1968
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well documented clinical report

Data source

Reference
Reference Type:
publication
Title:
[Pneumoconiosis due to cerium] (article in French)
Author:
Nappée J, Bobrie J, Lambard D
Year:
1972
Bibliographic source:
Arch Mal Prof. 33(1): 13-8

Materials and methods

Study type:
clinical case study
Endpoint addressed:
repeated dose toxicity: inhalation
Test guideline
Qualifier:
no guideline required
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
Cerium oxide or Cerox
IUPAC Name:
Cerium oxide or Cerox

Method

Type of population:
occupational
Subjects:
- Number of subjects exposed: 2
- Sex: Male
- Age: 62 years old (subject 1) / 59 years old (subject 2)
- Race: Not specified
- Demographic information: 15 years in cerium oxide preparation, smoker (20 cigarettes/day) (subject 1) / 11 years in cerium oxide preparation, smoking status not provided
- Known diseases: None (suject 1) / Past ulcer on right leg (subject 2)
- Other: Workers in a plant in the region of La Rochelle (France) in an extraction workshop
Ethical approval:
not applicable
Route of exposure:
inhalation
Reason of exposure:
intentional, occupational
Exposure assessment:
not specified
Examinations:
Pulmonary examination, cardiac examination (one worker), bone radiography, bronchoscopy, bronchial anatomopathology (biopsy), respiratory functional exploration, clinical biology
Medical treatment:
None

Results and discussion

Clinical signs:
No relevant clinical sign reported
Results of examinations:
Cerium oxide pneumoconiosis was diagnosed in two workers exposed to cerium oxide by inhalation for 11 or 15 years in an extraction workshop of this rare earth. The level of exposure was unknown. This pneumoconiosis practically did not modify the respiratory function. It rather appeared only as a pulmonary overload of cerium oxide which is opaque to X-rays.

Any other information on results incl. tables

Table: Results of examinations in the two workers

 

 

Subject 1

Subject 2

Pulmonary examination

Normal auscultation – Pulmonary radiography for 3 years from November 1967 show constant reticulo-nodulation in the whole lungs. No mediastinal lymphoadenopathy.

Normal auscultation – Pulmonary radiography for 2 years from December 1968 show 2-3 mmdiameter pulmonary nodules in both lungs, more particularly basal left lung. No hilum lymphoadenopathy.

Cardiac examination

Normal (electrical and clinical) - blood pressure 14 -8

Normal (electrical and clinical) - blood pressure 16-9

Bone radiography

Normal

Normal

Bronchoscopy

Bronchitis aspect (mucosa more red than normal and a few non-purulent secretions)

Bronchial spasms, red and inflamed mucosa, with mucous secretions

Bronchial anatomopathology

Ciliated cylindrical epithelium interrupted on a portion by a malpighian metaplasia, going back to the cylindrical type afterwards. Chorion particularly rich in seromucous glands, surrounded by lymphocytic infiltration, without specific arrangement.

Malpighian metaplasia in a really localised aera of the bronchial mucosa epithelium. Discrete inflammatory infiltration in superficial chorion, with quite dense collagenous sclerosis. Attributed to chronic inflammatory lesions without specific etiology.

Respiratory functional exploration

Slight restriction (around 30%) – No sign of obstruction or distension –Normalblood gaz

Slight restriction (around 30%) – No sign of obstruction or distension –Normalblood gaz

Clinical biology

Positive tuberculosis intradermo reaction – Negative search for tuberculosis agent – Metopyrone test: negative – Other clinical biology tests: normal

Positive tuberculosis intradermo reaction – Negative search for tuberculosis agent – Metopyrone test: negative – Other clinical biology tests: normal

Applicant's summary and conclusion

Conclusions:
Cerium oxide pneumoconiosis was diagnosed in two workers exposed to cerium oxide by inhalation for 11 or 15 years in an extraction workshop of this rare earth. The level of exposure was unknown. This pneumoconiosis practically did not modify the respiratory function. It rather appeared only as a pulmonary overload of cerium oxide which is opaque to X-rays.