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Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
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.
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
Species:
human
Strain:
other: not applicable
Sex:
not specified
Route:
other:
Vehicle:
no data
Concentration / amount:
no data
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
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.
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Although tartaric acid was predicted to be sensitizer by a valid QSAR model; no case of skin/respiratory sensitization was observed in health surveillance studies (published data).

Based on the chemical structure, it is considered that the sensitizing potential of tartaric acid is the same of that ones of its salts (i.e. monosodium, monopotassium, sodium potassium, sodium, potassium and calcium tartrate) and, therefore, the assessment of this endpoint may be jointly performed using all available data for these substances. Therefore, also the tartaric acid salts are deemed to be not sensitizer.


Migrated from Short description of key information:
Tartaric acid and its salts are not sensitizer.

Justification for selection of skin sensitisation endpoint:
This endpoint study record has been selected since it contains human data which have to be considered as priority in accordance with REACH and CLP regulations.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:
Tartaric acid was predicted to be a skin sensitizer by a valid QSAR model; on the other hand, no case of skin/respiratory sensitization was observed in health surveillance studies (published data). Based on the chemical structure, it is considered that the sensitizing potential of tartaric acid is the same of that one of its salts (i.e. monosodium, monopotassium, sodium potassium, sodium, potassium and calcium tartrate) and, therefore, the assessment of this endpoint may be jointly performed using all available data for these substance. Nevertheless, the information available do not allow a comprehensive evaluation of the endpoint.

Migrated from Short description of key information:
The substance is evaluated as sensitizer based on data predicted by a valid QSAR model; on the other hand, no case of skin/respiratory sensitization was observed in health surveillance studies (published data).

Justification for classification or non-classification

According to Directive 67/548/EEC and to Regulation (EC) n. 1272/2008, the substances should not be classified for the skin sensitization because the data are judged as "conclusive but not sufficient for the classification".

According to Directive 67/548/EEC and to Regulation (EC) n. 1272/2008, the substances should not be classified for the respiratory sensitization because the data are judged as "inconclusive".