1,3,5,7-Tetraazatricyclo[3.3.1.13,7]decane, mononitrate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

March - June 2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Report date:

2017

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

3,5,7-triaza-1-azoniatricyclo[3.3.1.13,7]decane nitrate

EC Number:

687-538-5

Cas Number:

18423-20-6

Molecular formula:

C6H13N5O3

IUPAC Name:

3,5,7-triaza-1-azoniatricyclo[3.3.1.13,7]decane nitrate

Specific details on test material used for the study:

Test item: Hexamine Nitrate
Batch: Marzo 17 palet 403
Supplier: MAXAM
Physical and chemical properties / Propiedades físico-químicas
Physical state: Solid (powder)
Purity: >96 %
Colour: White
Molecular weight: 203.199 g/mol

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

Species: Rat
Strain: Hsd: Sprague Dawley® SD®
Sex: Female
Colour: Albino
Health status *: Specific Pathogen Free (SPF) / Libres de Patógenos Específicos
Rationale for selection of species / strain /
Rats are a suitable rodent species, acceptable to regulatory authorities as indicators of potential hazards, and for which extensive background data are available. Literature surveys of onventional LD50 tests showed that, although there is little difference in sensitivity between the sexes, in those cases where differences were observed females are generally slightly more sensitive

Total number of animals:
8 animals to perform 2 dose steps (3 animals used per step and 2 spare animals)
Age of the animals on arrival:
8-week-old rats
Animals per cage: At least 2
Bedding material: Capsumlab Lecho_10
Change of cages: At least once a week and when deemed necessary throughout the,study period
Inclusion criteria on arrival:Examen veterinario
Acclimatisation period: 8 days
Animal identification: Digit ink marks

Administration / exposure

Route of administration:

other: Oral gavage (with a suitable intubation cannula)

Vehicle:

water

Doses:

Dose (mg/kg): 2,000 (dose step 1 and 2)
Dose volume (mL/kg):10
Rationale for dose selection: Doses selected according to the OECD guideline nº 423. The starting dose level should be that which is most likely to produce mortality in some of the dosed animals.

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No test item-related mortality was recorded during the study period in any of the two groups administered with a dose of 2,000 mg/kg p.o.

Clinical signs:

other: All animals showed a normal behavior and appearance and no signs of systemic toxicity occurred in response to the test item in in any of the two groups administered with a dose of 2,000 mg/kg p.o.

Gross pathology:

At the end of the 14-day observation period (study days 15 and 20), all animals were euthanized in a CO2 atmosphere. A gross necropsy consisting in a macroscopic evaluation of all the external body orifices and the examination of the abdominal and thoracic cavities and contents was performed. All gross pathological
changes were recorded for each animal. Any organ with gross lesions or abnormalities was collected and preserved in fixation medium (neutral-buffered 4% formaldehyde) for possible microscopic examination.

Other findings:

No macroscopic findings or morphological changes were observed in the evaluated organs at necropsy except for the red spots seen on the kidneys of animal ID 1. However, since no adverse local or systemic signs were recorded in this animal during the observation period, this finding was likely related to a potential congestion/blood resorption during euthanasia, rather than to a test item-related effect.

Applicant's summary and conclusion

Interpretation of results:

other: GHS criteria for classes 1,2,3 and 4 not met

Conclusions:

Taking into account the results obtained in the current study, it is concluded that, under the assayed experimental conditions and according to the OECD guideline for the Testing of Chemicals Nº. 423, the test Hexamine Nitrate could be ranked in the Category 5 or Unclassified of the Globally Harmonised Classification System for Chemical Substances and Mixtures.