Urea, reaction products with formaldehyde, glyoxal and methanol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 23 OCT 1985 to 7 NOV 1985

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Urea, reaction products with formaldehyde, glyoxal and methanol

EC Number:

296-665-1

EC Name:

Urea, reaction products with formaldehyde, glyoxal and methanol

Cas Number:

92908-36-6

Molecular formula:

C2 H2 O2 .C H4 N2 O .C H4 O .C H2 O

IUPAC Name:

Urea, reaction products with formaldehyde, glyoxal and methanol

Specific details on test material used for the study:

- Lot No.: 141284

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Iffa Credo, St Germain sur l'Arbresle, France
- Weight at study initiation: males (mean): 124 g; females (mean): 120 g
- Fasting period before study: 18 h
- Housing: 5 animals/sex/cage in fully conditioned rooms
- Diet: standard rat diet of Ref. A04C (U.A.R, Villemoisson sur Orge, France), ad libitum
- Water: flitered water (Millipore membrane 0.22 µm), ad libitum
- information on diet testing dealing with contaminants were given by provider with each lot; water was tested regularly on bacterial contamination
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+/-3
- Humidity (%): 50+/-20
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

5 ml/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: several times in the hours following the application, at least once daily during the 14 day observation period
- Frequency of weighing: just before application and then on day 4, day 8 and day 15
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 mL/kg bw

Based on:

test mat.

Remarks on result:

other: no animals died during the 14 day observation period, corresponding to 6150 mg/kg bw (density set 1.23 g/cm³), corresponding to 4305 mg submission substance per kg bw

Mortality:

- no deaths occured

Clinical signs:

other: - all animals were sedated within the first 30min up to about 3 h - from 3 hours post apllication until the end of the study no more clinical signs were observed

Gross pathology:

- no macroscopically visible changes were linked to the substance treatment

Other findings:

- Histopathology: was not performed due to the fact that there were no macroscopically visible changes

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Single application of a limit dose of 5 mL of test substance per kg bw did not cause lethality in male and female Wistar rats during the 14 day observation period, thus resulting in a LD50 > 5 mL/kg bw (corresponding to 6150 mg test item/kg bw based on a density of 1.23 g/cm³ (i.e. 4305 mg submission substance per kg bw)).

Executive summary:

Male and female Wistar rats (5/sex) were subjected to test acute oral toxicity according to a standard acute method (EU method B1). The test material was administered by gavage at a limit dose of 5 mL/kg bw. Besides some minor effects occurring after application (transient sedation in between 0.5 and 3 hours post application) no other clinical effects were seen. No animal died during the 14 day observation period, resulting in a LD50 > 5 mL/kg bw (corresponding to 6150 mg test item/kg bw based on a density of 1.23 g/cm³ (i.e. based on the concentration of 70% of the submission substance in the test item: 4305 mg submission substance per kg bw)). Therefore, the substance has not to be classified for acute oral toxicity according to regulation (EC) No. 1272/2008.