Disodium tartrate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

publication

Title:

MONOSODIUM L(+) TARTRATE TOXICITY IN TWO YEAR DIETARY FEEDING TO RATS

Author:

Hunter, B. et al.

Year:

1977

Bibliographic source:

Toxicology 8: 263-274

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

- Principle of test: 2-year dietary feeding study (Repeated Dose Toxicity, oral)
- Short description of test conditions: Groups of 35 male and female Sprague-Dawley rats were subjected to a 2-year dietary feeding study, where they received daily doses of the test substance via the food (commercial diet) at dose levels of 25600, 42240, 60160, 76800 ppm. Mortality was assessed daily.
- Parameters analysed / observed: clinical signs, macroscopic pathology, tumorigenic response

GLP compliance:

not specified

Test type:

other: 2-year dietary feeding study

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Sodium hydrogen tartrate

EC Number:

208-400-9

EC Name:

Sodium hydrogen tartrate

Cas Number:

526-94-3

Molecular formula:

C4H6O6.Na

IUPAC Name:

sodium hydrogen tartarate

Test material form:

solid

Test animals

Species:

rat

Strain:

Sprague-Dawley

Remarks:

CFY rats, hysterectomy-derived strain

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Anglia Laboratory Animals, Huntingdon, England
- Housing: 5 animals per cage in cages with wire mesh floors
- Diet: commercial diet (Spratt's Laboratory Animal Diet No. 2), ad libitum
- Water: tap water, ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 2
- Humidity (%): 50 ± 5
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: feed

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

DOSAGE PREPARATION (if unusual): Diet containing different concentrations of test substance.

Doses:

25600, 42240, 60160 or 76800 ppm
which corresponds for males: 890, 1620, 2200 or 3100 mg/kg bw /day
which corresponds for females: 1190, 2050, 3030 or 4100 mg/kg bw /day

No. of animals per sex per dose:

35 males and 35 females per dose group

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 2 years
- Frequency of observations and weighing: animals were observed daily and individual body weights were determined weekly
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights, histopathology, other: food intake and tumorigenic response

Statistics:

Student's t-test assessing the significance of intergroup differences, mortality was analysed using Fisher's Exact Probability test used as a 'one-tailed' test

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

> 3 100 mg/kg bw

Based on:

test mat.

Effect levels 2

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 4 100 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred during the study period relevant for acute oral toxicity (14 days)

Clinical signs:

No clinical signs of toxicity were observed during the study period relevant for acute oral toxicity (14 days)

Body weight:

A dosage-related reduction in bodyweight gain compared to control animals could be observed in all treatment groups during the study period relevant for acute oral toxicity (14 days)

Gross pathology:

Necropsy and histopathological examination revealed no substance-related findings.

Applicant's summary and conclusion

Interpretation of results:

other: CLP/ EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008

Conclusions:

CLP: not classified