Reaction products of ethylene glycol, urea and paraformaldehyde (EUF)

Acute Toxicity: oral

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:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Report date:

2008

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

reaction products of ethylene glycol, urea and paraformaldehyde

EC Number:

700-934-5

Molecular formula:

No exact molecular formula can be given for a complex reaction mixture (UVCB substance).

IUPAC Name:

reaction products of ethylene glycol, urea and paraformaldehyde

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 or test system 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 main 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:

other: 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.

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:

GHS criteria not met

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 (limit test). 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.