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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin 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
Type of study:
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.

In vivo test system

Test animals

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

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
other:
Vehicle:
no data
Concentration / amount:
no data
Challengeopen allclose all
Route:
other: dermal
Vehicle:
no data
Concentration / amount:
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

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
other: human observation
Group:
test group
Dose level:
1-17.7 mg/m3
No. with + reactions:
0
Total no. in group:
44
Clinical observations:
summer: no sensitisation reactions were observed in workers exposed to the substance
Remarks on result:
other: Reading:
Reading:
other: human observation
Group:
test group
Dose level:
0.18-9 mg/m3
No. with + reactions:
0
Total no. in group:
44
Clinical observations:
winter: no sensitisation reactions were observed in workers exposed to the substance
Remarks on result:
other: Reading:

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
No sensitisation reactions were observed in workers exposed to the substance neither in winter nor in summer.
Executive summary:

The investigations carried out have shown skin damages localized in the most part of cases in hands and were linked to the direct contact to the powder.

No skin sensitisation reactions were observed in workers directly or indirectly exposed to the substance.