Registration Dossier

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:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
GLP compliance:
yes (incl. certificate)
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals 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:
none
Body weight:
No abnormal findings
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.