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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:
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.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report Date:
1975

Materials and methods

Test guideline
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

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified
Details on test material:
Compound FDA 71-55

Test animals

Species:
rat
Strain:
not specified
Sex:
male
Details on test animals and environmental conditions:
average body weight 349 g

Administration / exposure

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

Results and discussion

Effect levels
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

Any other information on results incl. tables

Acute Toxicity Data

 Dose (mg/kg)  Dead/Animals  Day of Death and Necropsy
 5000  1/10  Day 5(1): no gross findings

Applicant's summary and conclusion

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.