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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
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 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method

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:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Italy, S. Pietri Natisone (UD)
- Weight at study initiation: 189-205 g
- Fasting period before study: the rats have been kept without food during the night before the beginning of the test and for 4 hours after administration.
- Housing: Animals have been put in cages of transparent polycarbonate with sizes of mm 425X266X180 (lxwxh), separated by sex so that in each cage there were 5 animals of the same sex
- Diet (e.g. ad libitum): ad libitum
- 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): 12h

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 200mg/ml

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: the day of the test three female rats were treated with test sample at the dose of 2000 mg/kg. Because only one case of mortality has been observed in the following 9 days another group of three rats has been treated at the same conditions.
Doses:
2000 mg/kg
No. of animals per sex per dose:
3 female per dose
Control animals:
no
Details on study design:
-Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observed every morning of the working week. weighted before the experiment, after 7 days and then at the end of the study.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights, histopathology, other:
Clinical observations including general objective exam enclosed:
Evaluation of organic bodies function;
Evaluation of tegumentary apparatus;
Evaluation of mucus conditions;
Evaluation of somatomotor activity and sensorial conditions.
Statistics:
no data

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
>= 2 000 - <= 5 000 mg/kg bw
Based on:
test mat.
Mortality:
Female (Group I): one case of mortality was observed during the study.
Female (Group II): one case of mortality was observed during the study.
Clinical signs:
Female (Group I): In all animals piloerection was observed 2 hours after treatment, symptoms disappear completely 6 days after treatment.
Female (Group II): In all animals piloerection was observed 2 hours after treatment, symptoms disappear completely 5 days after treatment.
Body weight:
Female (Group I): the treated animals' weight increase was inferior with the standard of species and race in the first week of the study, complied in the second.
Female (Group II): the treated animals' weight increase was inferior with the standard of species and race in the first week of the study, complied in the second.
Gross pathology:
Female (Group I): at the autopsy two rats have shown heavy mucosa enteritis, one animal has shown heavy stomach meteorism with a moderate gastric mucosa haemorrhage. The intestinal tract has shown a heavy meteorism with heavy muco-hemorragic enteritis.
Female (Group II): at the autopsy two rats have shown moderate mucosa enteritis, one animal has shown a slight stomach hemorrhage with a slight gastric mucosa haemorrhage. The intestinal tract has shown a heavy meteorism with heavy muco-hemorragic enteritis.

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Remarks:
Migrated information
Conclusions:
On the basis of the obtained results, interpreted according to OECD number 423 December 17th 2001, the test product “tartaric acid” has a LD50 > 2000 mg/kg bw and is included into the Acute Toxicity category 5 according to the GHS classification system.
Executive summary:

An acute oral toxicity test was performed with the test substance “tartaric acid” in order to obtain the necessary data to evaluate its toxic effects, by means of gavage. In a 2000mg/kg dose to 6 female rats (divided into two groups). 4 hours after the treatment the animals have been fed with a standard pellet diet. During the study the animals have been observed daily for 14 days, to notice possible toxic symptoms. One case of mortality was observed in each group. On the basis of the obtained results, interpreted according to OECD Guideline 423 December 17th2001, the test product has a LD50 > 2000 mg/kg bw and is included into the acute toxicity category 5 according to the GHS claasificcation system.