Registration Dossier

Administrative data

Description of key information

Tartaric acid and its salts does not have significant acute toxicity.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1975
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.
Reference:
Composition 0
Qualifier:
no guideline followed
Principles of method if other than guideline:
no data
GLP compliance:
not specified
Test type:
other: no data
Limit test:
yes
Test material information:
Composition 1
Species:
rat
Strain:
not specified
Sex:
male
Details on test animals and environmental conditions:
average body weight 349 g
Route of administration:
oral: unspecified
Vehicle:
physiological saline
Details on oral exposure:
The substance was pregared as a 29 (w/v) solution in 0.85% saline and administered orally
Doses:
one dose only: 5000 mg/kg bw
No. of animals per sex per dose:
ten male rats
Control animals:
not specified
Statistics:
no data
Sex:
male
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No signs of toxicity or abnormal behavior was observed in the seven-day observation period
Mortality:
One death occurred on day 2.
Clinical signs:
no data
Body weight:
no data
Gross pathology:
On necropsy no gross findings were observed (neither in the dead animal nor in the survivors)
Other findings:
no data

Acute Toxicity Data

 Dose (mg/kg)  Dead/Animals  Day of Death and Necropsy
 5000  1/10  Day 5(1): no gross findings
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute oral LD50 for compound FDA 71-55 (tartaric acid) is considered to be greater than 5000 mg/kg.
Executive summary:

The acute oral LD50 for compound FDA 71-55 (tartaric acid) is considered to be greater than 5000 mg/kg.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
5 000 mg/kg bw
Quality of whole database:
Database does not contain data obtained by means of tests in accordance with standard testing guidelines; however, it is constituted by many data which are consistent about the absence of significant acute toxicity.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
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.
Reference:
Composition 0
Qualifier:
no guideline followed
Principles of method if other than guideline:
Subcutaneous exposition of in vivo animals to the substance to evaluate its acute toxicity.
GLP compliance:
not specified
Test type:
other: no data
Test material information:
Composition 1
Specific details on test material used for the study:
no data
Species:
rabbit
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
no data
Type of coverage:
not specified
Vehicle:
not specified
Details on dermal exposure:
no data
Duration of exposure:
no data
Doses:
400 mg/kg
800 mg/kg
1000 mg/kg
No. of animals per sex per dose:
no data
Control animals:
not specified
Details on study design:
no data
Statistics:
no data
Preliminary study:
no data
Sex:
not specified
Dose descriptor:
other: lethal dose
Effect level:
ca. 400 mg/kg bw
Based on:
test mat.
Remarks on result:
other: 6/7 animals died in 6-7 days
Sex:
not specified
Dose descriptor:
other: lethal dose
Effect level:
ca. 1 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no effects
Sex:
not specified
Dose descriptor:
other: lethal dose
Effect level:
>= 1 200 - <= 1 500 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Toxic
Sex:
not specified
Dose descriptor:
other: lethal dose
Effect level:
ca. 800 mg/kg bw
Based on:
test mat.
Remarks on result:
other: 6/9 rabbits survived

Animals which were fed oats or oats and cabbage succumbed to a dose of 0.4 gm. of the salt per kilo when given by subcutaneous injection, Suppression of urine was usually observed on the first day and death occurred in six to seven days. In starvation, slightly smaller doses were fatal to some rabbits. The resistance was increased considerably when the diet was changed to carrots, Such animals stood 1.0 gm. per kilo by subcutaneous injection, while 1.2-1.5 gm. per kilo were toxic. A moderate degree of tolerance for tartrates was induced in animals which were fed oats and cabbage. By gradually increasing the dose, a large proportion (6 out of 9) of rabbits survived 0.8 gm. per kilo which is twice the fatal dose. Rabbits which were receiving carrots did not acquire tolerance for tartrates.

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Sodium tartrate showed different tolerance which depended on diet following subcutaneous administration.
Executive summary:

Sodium tartrate showed different tolerance which depended on diet following subcutaneous administration.

Endpoint conclusion
Endpoint conclusion:
no study available
Quality of whole database:
A complete database is available for the acute toxicity by subcutaneous route. Although it does not contain data obtained by means of tests in accordance with standard testing guidelines, it is constituted by many data which are consistent about the absence of significant acute toxicity. Therefore, further investigation by dermal route are deemed to be not needed.

Additional information

The acute toxicity of tartaric acid and its salts was investigated by means of several tests principally performed by means of oral and subcutaneous administration. Almost all data support the absence of significant acute toxicity for both exposure routes. A single LD50 value of 920 mg/kg was observed for tartaric acid, in disagreement with all the others LD50 values for tartaric acid and its salts.

Overall, it is considered that the systemic acute toxicity of tartaric acid is similar to that ones of its salts (i.e. monosodium, monopotassium, sodium potassium, sodium, potassium and calcium tartrate) and, therefore, the assessment of these endpoints may be jointly performed using all available data for these substances. Therefore, tartaric acid and its salts are deemed to be not acutely toxic.

With regard to the specific target organ toxicity, adverse effects on kidney (i.e. nephritis) were reported in some tests. However, these effects were only observed at very high dose levels close to the lethal dose (> 2000 mg/kg bw).


Justification for selection of acute toxicity – oral endpoint
This study has been selected since it is well documented. Overall, the assessment of the acute oral toxicity of tartaric acid and its salts are based on the weight of evidence of the available data.

Justification for selection of acute toxicity – dermal endpoint
Several data are available about the acute toxicity by subcutaneous route. This study has been selected since it is well documented. Overall, the assessment of the acute oral toxicity of tartaric acid and its salts are based on the weight of evidence of the available data.

Justification for classification or non-classification

According to Directive 67/548/EEC and to Regulation (EC) n. 1272/2008, the study results indicate that the substances should not be classified for acute oral toxicity because data are judged as "conclusive but not sufficient for classification".

According to Directive 67/548/EEC and to Regulation (EC) n. 1272/2008, the substances should not be classified for acute inhalation toxicity because of data lacking.

According to Directive 67/548/EEC and to Regulation (EC) n. 1272/2008, the study results indicate that the substances should not be classified for acute dermal toxicity because the data currently available 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 the substances should not be classified for specific target organ toxicity - single exposure because data are judged as "inconclusive".