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

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

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

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Health status : Specific Pathogen Free (SPF)
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. Both sexes are dosed to establish that animals of one sex are not markedly more sensitive to the test substance

Total number of animals: 14 animals (10 –5 males and 5 females– used in the study and 4 spare animals)
Age of the animals on arrival: 8-week-old rats / 8 semanas
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:Veterinary inspection
Acclimatisation period: 7 days
Animal identificationl: Digit ink marks

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

water

Details on dermal exposure:

Approximately 24 hours before the test, fur was removed from the dorsal area of the trunk of the animals by shaving. Care was taken to avoid abrading the skin, which could alter its permeability.The required volume of test item was spread on a sterile gauze patch (which does not exceed 10% of the total body surface area*) and was held in contact with the skin with a semi-occlusive bandage and a suitable dressing.
Animals were trained to wear the suitable dressing during the acclimatisation period.

Duration of exposure:

Exposure period: 24h

Doses:

Single dose (2000 mg/kg). Dose selected according to the OECD guideline nº 402.

Results and discussion

Effect levels

Key result

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 males or females administered topically with a dose of 2,000 mg/kg.

Clinical signs:

other: All animals showed a normal behaviour and no systemic toxic signs were recorded throughout the whole 14- day observation period. The only local reaction associated with the test item application was that, immediately after patch removal, the skin from the

Other findings:

Neither macroscopic findings nor morphological changes were observed in the evaluated organs at necropsy
with the exception of the test item treated skin, which had a yellowish colour and was collected together with
normal untreated skin from the back. Both samples from each animal were preserved in fixative medium for
further analysis upon sponsor request.

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 Testing of Chemicals Nº 402, the dermal
LD50 for the test item Hexamine Nitrate is established to be > 2000 mg/kg body weight. However, it is
important to point out that a 24h-exposure to this test item resulted in an intense yellow staining of the skin at
the area of administration.