Registration Dossier

Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation, other
Remarks:
medical monitoring
Type of information:
other: Data sharing dispute
Adequacy of study:
key study
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 met hodology 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

Constituent 1
Chemical structure
Reference substance name:
(+)-tartaric acid
EC Number:
201-766-0
EC Name:
(+)-tartaric acid
Cas Number:
87-69-4
Molecular formula:
C4H6O6
IUPAC Name:
(2R,3R)-2,3-dihydroxybutanedioic acid
Test material form:
not specified

In vivo test system

Test animals

Species:
other: human
Strain:
other: not applicable
Sex:
not specified
Details on test animals and environmental conditions:
not specified

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
other: human observation
Group:
test chemical
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: other: human observation. Group: test group. Dose level: 1-17.7 mg/m3. No with. + reactions: 0.0. Total no. in groups: 44.0. Clinical observations: summer: no sensitisation reactions were observed in workers exposed to the substance.
Reading:
other: human observation
Group:
test chemical
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: other: human observation. Group: test group. Dose level: 0.18-9 mg/m3. No with. + reactions: 0.0. Total no. in groups: 44.0. Clinical observations: winter: no sensitisation reactions were observed in workers exposed to the substance.

Applicant's summary and conclusion

Interpretation of results:
other: not sensitising 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.

Categories Display