Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
November 05 to November 27 (experimental period)
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
fixed dose procedure

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): TPI 1618
- Substance type: Formaldehyde releaser
- Physical state: Colourless liquid
- Analytical purity: 100%
- Composition of test material, percentage of components: ethylene glycol, urea, paraformaldehyde
- Purity test date: 25. October 2007
- Lot/batch No.: 1118965
- Expiration date of the lot/batch: December 2008
- Stability under test conditions: freshly prepared shortly prior to administartion
- Storage condition of test material: dry, room temperature

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland GmbH, 97633 Sulzfeld
- Age at study initiation: not detailed
- Weight at study initiation: 142-172g (on day of dosing)
- Fasting period before study: overnight
- Housing: In macrolon cages, 2 or 3 animals per cage
- Diet : ad libitum
- Water : e.g. ad libitum
- Acclimation period: 5 days

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

IN-LIFE DATES (DOSING): Sighting study: November 6th, 2007; Main study: November 14, 2007

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 20%
- Amount of vehicle (if gavage): 80%
- Justification for choice of vehicle: Soluble in water


MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Fixed dose method, started with 2000 mg/kg bw.
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
1 female used for sighting study
4 females used for mauin experiment
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Body weight recording: day 0 (test start), day 7 day 14 ; Clinical signs: each rat was observed 30 min., 2, 4 and 6 hours post-dosing and daily thereafter over a period of 14 day

- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
No preterminal deaths. Therefore no statistical proceduresecessary

Results and discussion

Preliminary study:
1 female was dosed at 2000 mg/kg bw.
Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no preterminal deaths. Therefore no CL determined
Mortality:
No animal died
Clinical signs:
Hunched posture and piloerection were observed from 30 min. p.a. onwards up to 6 hours. From Day 1 to the end of the observation period, the animals were free of any abnormalities.
Body weight:
Not affected
Gross pathology:
No specific findings

Any other information on results incl. tables

 

Table for Acute Oral Toxicity of TPI 1618

Dose [mg/kg bw]

Number of dead /
number of investigated

Time of death (range)

Observations

2000

females 0/4

n.a.

Clinical signs:
piloerection, hunched posture,

 

LD50value (females)

> 2000 mg/kg bw

 

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
The results of the study indicate that the acute oral toxicity in female animals was above 2000 mg/kg body weight.
Executive summary:

Study was performed according to OECD guideline 420 (fixed dose procedure). One dose level of 2000 mg/kg bw. was used and applied orally as single administration to 4 females rats.
All survivors were subjected to a 14 days post-treatment observation period. All rats were observed for clinical signs, body weight development. Macroscopic findings were recorded in all animals.

No animal died. Clinical signs observed at the 2000 mg/kg dose level were piloerection and hunched posture p to 6 hours post dosing. Body weight development was within normal ranges. No macroscopic organ findings were observed at necropsy.