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Toxicological information

Skin irritation / corrosion

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Administrative data

skin irritation / corrosion, other
medical monitoring
Type of information:
other: Data sharing dispute
Adequacy of study:
key study
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.
Justification for type of information:
The study has been assessed for the use in a category approach and it was judged as appropriate because it's human-based. According to the methodology and to the extent of available details, the study has been judged as reliable with restrictions.

Data source

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

Materials and methods

Test guideline
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

Constituent 1
Chemical structure
Reference substance name:
(+)-tartaric acid
EC Number:
EC Name:
(+)-tartaric acid
Cas Number:
Molecular formula:
(2R,3R)-2,3-dihydroxybutanedioic acid
Test material form:
not specified
Specific details on test material used for the study:
no data

In vitro test system

Test system:
other: not relevant
Source species:
other: not relevant
Cell type:
other: not relevant
Cell source:
other: not relevant
Source strain:
other: not relevant
Details on animal used as source of test system:
not relevant
Justification for test system used:
not relevant
not specified
Details on test system:
no data
Control samples:
other: no data
Amount/concentration applied:
not relevant
Duration of treatment / exposure:
not relevant
Duration of post-treatment incubation (if applicable):
not relevant
Number of replicates:
not relevant

Test animals

other: human
other: not applicable
Details on test animals or test system and environmental conditions:
not relevant

Test system

Type of coverage:
other: Evaluation of human workers occupationally-exposed to tartaric acid.
Preparation of test site:
not specified
not specified
other: subject not exposed to tartaric acid
Amount / concentration applied:
no data
Duration of treatment / exposure:
no data
Observation period:
no data
Number of animals:
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

Results and discussion

In vitro

Irritation / corrosion parameter:
other: not relevant
Vehicle controls validity:
other: not relevant
Negative controls validity:
other: not relevant
Positive controls validity:
other: not relevant
Remarks on result:
other: Not relevant Medical monitoring (human)
Other effects / acceptance of results:
not relevant

In vivo

Irritation parameter:
other: Skin irritation
other: Human observations
Time point:
other: Not relevant
other: Not relevant
Remarks on result:
other: Not relevant Medical monitoring (human)
Irritant / corrosive response data:
no data
Other effects:
no data

Any other information on results incl. tables

 Examined group










control group

not exposed





* p <0.001 data statistically significant.

Skin disorders

The skin disorders were observed in 34 subjects exposed to the substance (77.3%) and in 6 subjects not exposed to the substance (20%).

The most frequent symptoms in the exposed group are represented by:

- Acute skin irritation (30 cases)

- Skin irritation in the hands (24 cases)

- Irritation of the face and scalp (6 cases)

- Chronic cutaneous alterations (l0 cases)

- Periungual ulcers and fissures (22 cases)

Visual disorders

For what concern the visual apparatus, the results were acute irritation in 23 of the subjects exposed to the substance (52.3%) and in 8 of the subjects non-exposed to the substance (26.7%).

Overall remarks, attachments

Overall remarks


Applicant's summary and conclusion

Interpretation of results:
other: irritating Migrated information Criteria used for interpretation of results: EU
The test substance is concluded to be irritating to the skin.
Executive summary:

The investigations carried out have shown cutaneous lesions which developped with a different mode of action and a significantly greater frequency compared to the control group. The skin lesions were localized in the most part of cases in hands and were linked to the direct contact to the powder.