Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 23 April to 20 May, 2008
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP, guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report Date:
2008

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
other: HanRcc: WIST(SPF)
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: RCC Ltd
- Age at study initiation: 11 weeks

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 30-70 %
- Air changes (per hr): 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 23/4/2008 To:20/05/2008

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 0.476 g/mL
- Amount of vehicle (if gavage):10 mL/kg.

Doses:
2000 mg/kg
No. of animals per sex per dose:
3 females per dosing occasion
Control animals:
no
Details on study design:
- Duration of observation period following administration: 15 days
- Frequency of observations and weighing: mortality/clinical signs: 1, 2, 3 and 5 hours after administration on test day 1 and twice daily during days 2-15
Body weights: On test days 1 (prior to administration), 8 and 15.
- Necropsy of survivors performed: yes
Statistics:
No statistics performed

Results and discussion

Preliminary study:
No deaths or clinical signs for 3 females dosed at 2000 mg/kg
Effect levelsopen allclose all
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
other: Dose expressed for the main constituent content.
Sex:
female
Dose descriptor:
LD50
Effect level:
> 4 760 mg/kg bw
Based on:
test mat.
Remarks:
as is: Dose of substance as registered (including residual water necessary for the stability)
Mortality:
No deaths occurred during the study.
Clinical signs:
No clinical signs were observed during the course of the study
Body weight:
The body weight of the animals was within the range commonly recorded for this strain and age.
Gross pathology:
No macroscopic findings were recorded at necropsy.

Any other information on results incl. tables

The median lethal dose of TRIQUAT MONOMER (active ingredient) after single oral administration to female rats, observed over a period of 14 days is: LD50 (female rat): greater than 2000 mg/kg body weight.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Not classified according to the criteria of Annex VI Directive 67/548/EEC and EU GHS.
Executive summary:

Two groups, each of three female HanRcc:WIST (SPF) rats, were treated with TRIQUAT MONOMER by oral gavage administration at a dosage of 2000 mg/kg body weight in terms of the active ingredient. The test item was diluted in vehicle (purified water) at a concentration of 0.476 g/mL and administered at a dosing volume of 10 mL/kg.

The animals were examined daily during the acclimatization period and mortality, viability and clinical signs were recorded. All animals were examined for clinical signs within the first 30 minutes and approximately 1, 2, 3 and 5 hours after treatment on day 1 and once daily during test days 2-15. Mortality/viability was recorded at approximately 30 minutes, 1, 2, 3 and 5 hours after administration on test day 1 (with the clinical signs) and twice daily during days 2-15. Body weights were recorded on day 1 (prior to administration) and on days 8 and 15. All animals were necropsied and examined macroscopically.

All animals survived until the end of the study period. No clinical signs were observed during the course of the study. The body weight of the animals was within the range commonly recorded for this strain and age. No macroscopic findings were recorded at necropsy. The median lethal dose of TRIQUAT MONOMER (active ingredient) after single oral administration to female rats, observed over a period of 14 days is: LD50 (female rat): greater than 2000 mg/kg body weight.

Based on the results of this study, the test substance TRIQUAT MONOMER (active ingredient) is not classified according to the criteria of Annex VI of Directive 67/548/EEC and EU GHS.