Trisodium 6,6',6''-(1,3,5-triazine-2,4,6-triyltriimino)trihexanoate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Follows a recognised guideline and performed to GLP standards.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

trisodium 6,6',6"-(1,3,5-triazine-2,4,6-triyltriimino)trihexanoate

IUPAC Name:

trisodium 6,6',6"-(1,3,5-triazine-2,4,6-triyltriimino)trihexanoate

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Laboratories UK Limited, Bicester, Oxon, UK.
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation:
- Fasting period before study: Fasted overnight before study and 3-4 hours after dosing.
- Housing: Suspended solid-floor polypropylene cages furnished with woodflakes.
- Diet (e.g. ad libitum): ad libitum (2014 Teklad Global Rodent diet, supplied by Harlan Teklad, UK).
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25 C
- Humidity (%): 30-70%
- Air changes (per hr): 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12 hour light / 12 hours dark

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: distilled water

Details on oral exposure:

Animals dosed once by oral gavage using a metal cannula attached to a graduated syringe. The volume administered to each animal was calculated according to its fasted bodyweight at the time of dosing.

Doses:

2000 mg/kg (administered as a 10 ml/kg solution of a 200 mg/ml concentration)

No. of animals per sex per dose:

Sighting study: Intitally 1 animal at a dose level of 2000 mg/kg
In the absence of toxicity, an additional group of 4 females will be given the same dose of 2000 mg/kg.

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations were made 0.5, 1, 2 and 4 hours after dosing and subsequently once daily for 14 days. Morbidity and mortality checks were made twice daily. Individual bodyweights were recorded on day 0 and on days 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology

Results and discussion

Preliminary study:

Sighting test revealed no clinical features or any other abnormal finding.

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

none

Clinical signs:

other: none

Gross pathology:

No abnormal findings

Other findings:

none

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute oral median lethal dose (LD50) of trisodium 6,6',6"-(1,3,5-triazine-2,4,6-triyltriimino)trihexanoate in the female Wistar strain rat was estimated to be greater than 2000 mg/kg bodyweight.

Executive summary:

In an acute oral toxicity study, a group of 4 fasted female (8 -12 weeks old) Wistar rats were given a single oral dose of trisodium 6,6',6''-(1,3,5 -triazine-2,4,6 -triyltriimino)trihexanoate in distilled water a dose of 2000 mg/kg bw and observed for 14 days.

 

Oral LD₅₀ Females = >2000  mg/kg bw

     

Trisodium 6,6',6"-(1,3,5 -triazine-2,4,6 -triyltriimino)trihexanoate is of low toxicity based on the LD₅₀in females.

 There were no treatment related clinical signs, necropsy findings or changes in body weight.