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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation
Remarks:
other: human monitoring
Type of information:
other: monitoring study (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 further details on the test material identity are available.
Specific details on test material used for the study:
no data

Test animals / tissue source

Species:
human
Strain:
other: not applicable
Details on test animals or tissues and environmental conditions:
not relevant

Test system

Vehicle:
not specified
Controls:
yes
Amount / concentration applied:
no data
Duration of treatment / exposure:
no data
Observation period (in vivo):
no data
Duration of post- treatment incubation (in vitro):
no data
Number of animals or in vitro replicates:
election 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 parameter:
other: not relevant
Run / experiment:
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

In vivo

Results
Irritation parameter:
other: eye irritation
Basis:
other: human observation
Reversibility:
not specified
Remarks on result:
other: The results obtained showed that the substance is irritating but data were not statistically significant.
Irritant / corrosive response data:
refer to the table of results in vivo
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 results obtained showed that the substance is irritating but data were not statistically significant.
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.

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%).