(+)-tartaric acid

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2010

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study in compliance with guidelines

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

(+)-tartaric acid

EC Number:

201-766-0

EC Name:

(+)-tartaric acid

Cas Number:

87-69-4

Molecular formula:

C4H6O6

IUPAC Name:

(2R,3R)-2,3-dihydroxybutanedioic acid

Details on test material:

- Name of test material (as cited in study report): tartaric acid
- Substance type: white powder
- Analytical purity: 99.5%
- Lot/batch No.: B 10X 1914

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Breeding Harlan Italy, S. Pietro al Natisone (UD)
- Weight at study initiation: 140-200 g
- Fasting period before study:
- Housing:
- Diet (e.g. ad libitum): animals have been fed with complete pelletized diet provided by Harlan Italy
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C):
- Humidity (%):
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12 h

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: 20 cm2
- % coverage: 10% of the total body surface
- Type of wrap if used: square of gauze

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Skin has been cleaned from sample excess by a tampon soaked in physiological solution
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg
- Constant volume or concentration used: yes
- For solids, paste formed: no

Duration of exposure:

24 hours

Doses:

2000 mg/kg

No. of animals per sex per dose:

5 males and 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days.
- Frequency of observations and weighing: the general status of all animals has been daily monitored after 1, 3, 5 hours from the start of treatment and daily (5 days per week) for 14 days.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:
Clinical symptomatology: Every clinical symptom, including possible variations of somato-motory activity, was daily registered for each individual animal. Clinical observations included a general objective exam (G. O. E) above:
assessment of major organic functions;
assessment of the status of integumentary apparatus;
assessment of the status of mucosae;
assessment of somato-motory activity and of the sensory status.

Body weight: animals have been weighted before experiment, after 7 days and at the end of the experiment.

Post morterm: at the end of the observation period, animals have been sacrofoced and a post-morterm examination has been carried out.

Statistics:

no data

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

During the study no mortality was detected.

Clinical signs:

other: During the study neither symptoms nor signs of toxicity were recorded.

Gross pathology:

No abnormalities have been observed in all the treated animals.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

On the basis of obtained results, according to Official Journal of the European Union 1272/2008 (CLP) dated December 16th 2008 and OECD Guideline 402 of February 24th 1987, the test substance “tartaric acid” has a LD50 > 2000 mg/kg bw and can be considered non-classified.

Executive summary:

An acute dermal toxicity test was performed with the test substance “tartaric acid” in order to obtain the necessary data to evaluate its toxic effects. The test product has been administered with a dose of 2000mg/kg by topical application to a group of 10 rats (5 males and 5 females). During the study animals have been daily observed for 14 days to detect possible toxic symptoms. No toxic effect was found. On the basis of obtained result, according to official journal of the European Union 1272/2008 (CLP) dated December 16^th2008 and OECD number 402 of February 24^th1987, the test substance “tartaric acid” has a LD50 > 2000 mg/kg bw and can be considered non-classified.