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Acute Toxicity: oral

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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

Constituent 1
Chemical structure
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:
- 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
Body weight:
- body weight development was not impaired
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.