Registration Dossier

Administrative data

Endpoint:
respiratory sensitisation
Remarks:
other: medical monitoring
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study has been assessed for the use in a category approach. According to the methodology and to the extent of available details, the study has been judged as reliable with restrictions.

Data source

Reference
Reference Type:
publication
Title:
Indagine su un gruppo di soggetti con esposizione professionale ad acido tartarico
Author:
Moscato et al.
Year:
1983
Bibliographic source:
ltal. Med. Lav. 1983; 5: 193-198.

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Evaluation of human workers occupationally-exposed to tartaric acid.
The study reports the results of un investigation carried out in a factory producing tartaric acid in order to evaluate the effects of occupational exposure to tartaric acid. A group of 74 subjects exposed to the acid and a group of 30 subjects not exposed, as a means of control, were submitted to unamnestic questionnaire.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
No further details on the test material identity are available.

Test animals

Species:
human
Strain:
other: not applicable
Sex:
not specified

Test system

Route of induction exposure:
other:
Route of challenge exposure:
inhalation
Vehicle:
not specified
Concentration:
no data
No. of animals per dose:
Selection of the subjects:
- 74 workers
44 subjects belonging to risk group, assigned the production of tartaric acid.
30 subjects belonging to the control group (not exposed to tartaric acid)
- history evaluated for each subject: occupational, family, medical
Details on study design:
no data
Challenge controls:
no data
Positive control substance(s):
not specified
Negative control substance(s):
other: not exposed subjects

Results and discussion

Applicant's summary and conclusion

Interpretation of results:
not sensitising