Tetradecanedioic acid

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Well documented publication that meets basic scientific principles (No data on GLP status)

Data source

Reference

Reference Type:

publication

Title:

Toxicity of disodium sebacate

Author:

Greco A.V., Mingrone G., Mastrimattei A. E., Finotti E., Castagneto M.

Year:

1990

Bibliographic source:

DRUGS EXPTL. CLIN . RES. XVI (10) 531 -536

Materials and methods

Principles of method if other than guideline:

After gavage of the test animals with a single dose of the test substance, the animals were examined for signs of toxicity and substance-dependent mortality. Gross pathological findings and body weights of the animals too were also monitored and recorded during the experiment. Necropsy was performed on animals that died before the end of the experiment. All surviving animals were sacrificed at the end of the examination period and necropsied.

GLP compliance:

not specified

Test type:

standard acute method

Test material

Test material information

Constituent 1

Reference substance name:

Disodium sebacate (DSS)

IUPAC Name:

Disodium sebacate (DSS)

Constituent 2

Reference substance name:

Disodium sebacate

EC Number:

241-300-3

EC Name:

Disodium sebacate

Cas Number:

17265-14-4

IUPAC Name:

disodium sebacate

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

- Doses higher than 5000 mg/kg bw were not used, since the DSS-containing volumes would have been too large for the stomach capacity of the animals tested
- Control groups of rats (4 male/4 female) were given NaCl solutions, whose sodium content corresponded to that of the test substance administered. Glucose was added to reach the same osmolarity of the test dose

Doses:

500; 1,000; 1,500; 2,000; 3,000; 4,000; 5,000 mg/kg bw

No. of animals per sex per dose:

4

Control animals:

yes

Statistics:

The DSS concentration used and percentage of mortality were respectively plotted on abscissa and ordinate of a logarithmic paper according to Miller and Tainter. The best fitting straight line of the plotted points allows the calculation of the LD50 which is the dosage value at 50% of mortality. The standard error (s .e.) was estimated by this formula: (doses 84% - 16%) x square root of (2N), where N is the number of animals contributing to the values plotted.

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Effect levels 2

Sex:

male/female

Dose descriptor:

other: NOAEL

Effect level:

>= 5 000 mg/kg bw

Mortality:

No substance related mortality was seen

Clinical signs:

other: No substance related clinical effects were seen

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information

Conclusions:

After oral administration of disodium sebacate to rats, no oral toxicity was found. Based on a read across (category approach), no classification regarding the acute oral toxicity is required for tetradecanedioic acid.