Registration Dossier

Administrative data

Description of key information

Tartaric acid is skin and eye irritant.
Tartaric acid salts are not skin/eye irritant.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
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.
Reference:
Composition 0
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 information:
Composition 1
Specific details on test material used for the study:
no data
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
Species:
human
Strain:
other: not applicable
Details on test animals and environmental conditions:
not relevant
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
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
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

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%).

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.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Link to relevant study records
Reference
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.
Reference:
Composition 0
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 information:
Composition 1
Specific details on test material used for the study:
no data
Species:
human
Strain:
other: not applicable
Details on test animals or tissues and environmental conditions:
not relevant
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
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
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

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%).

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%).

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

In order to assess the irritating potential, tartaric acid has to be considered independently by its salts. Indeed, the acid has a low pH value whereas its salts have values greater than or equal to 3.

Based on clinical investigations (human data), tartaric acid is deemed to be irritant for both skin and eye. Indeed, skin and eye irritation signs were observed in several workers who handled the substance. Also respiratory irritation was observed; however, this effect was judged by the (medical) authors to be related to the overall dustiness of the investigated work environment.

With regard to tartaric acid salts, hydrogen potassium tartrate (pH = 3) was injected in the rabbit ocular chamber and did not cause any significant adverse effect. In a clinical study, a solution of sodium hydrogen tartrate (pH = 3.5) was tested in human eye in order to assess its irritating potential. Although the test solution caused moderate stinging and a sensation of dryness, no injury was observed. The same test solution neutralized at pH 6 did not cause discomfort.

In the same way, a solution of tartaric acid neutralized at pH 3 (adding sodium phosphate) was tested on human eye. As result, severe stinging was felt by the tested subject but no injury was observed.

Overall, the pH is deemed to be the factor driving the irritating potential of these substances. In particular, it was observed that the handling of tartaric acid (which has a pH close to 2) was associated with significant skin/eye reactions. By contrast, test substances/solutions at pH equal to or higher than 3 caused only discomfort but no significant irritating effect (intended as damage or adverse reaction).

In conclusion, tartaric acid should be considered to be a sever skin/eye irritant. On the other hand, considering that the pH values of the tartaric acid salts are equal to or greater than 3, these substances should not be considered as irritant for both skin and eye.


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

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

Effects on skin irritation/corrosion: irritating

Effects on eye irritation: highly irritating

Justification for classification or non-classification

According to Directive 67/548/EEC and to Regulation (EC) n. 1272/2008, the study results indicate that tartaric acid should be classified as "Xi; R38" and as "skin irritant, category 2 (H315)", respectively.

According to Directive 67/548/EEC and to Regulation (EC) n. 1272/2008, the study results indicate that tartaric acid should be classified as "Xi; R41" and as "eye damage, category 1 (H318)", respectively.

According to Directive 67/548/EEC and to Regulation (EC) n. 1272/2008, the study results indicate that the tartaric acid salts should not be classified for the skin/eye irritation because the data are judged as "conclusive but not sufficient for classification".

According to Directive 67/548/EEC and to Regulation (EC) n. 1272/2008, study results indicate that tartaric acid and its salts should not be classified for specific target organ toxicity - single exposure (H335) because data are judged as "inconclusive".