Registration Dossier

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation / corrosion
Remarks:
other: medical monitoring
Type of information:
other: medical monitoring (human)
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.
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
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 details on test material identity are available.
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
Vehicle:
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

Species:
human
Strain:
other: not applicable
Details on test animals 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
Vehicle:
not specified
Controls:
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

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

In vivo

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

Any other information on results incl. tables

Responses to the questionnaires

Examined group

skin

disorder

eye

disorder

exposed

34*

(77.3%)

23

(52.3%)

control group

not exposed

6

 (20%)

8

(26.7%)

* 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%).

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
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.