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Toxicological information

Acute Toxicity: dermal

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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:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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:
During the study neither symptoms nor signs of toxicity were recorded.
Body weight:
Treated animals' weight was complied with the standard of species and race in first and in the second week of the study.
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 16th2008 and OECD number 402 of February 24th1987, the test substance “tartaric acid” has a LD50 > 2000 mg/kg bw and can be considered non-classified.