Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
April 15 through April 29, 1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: It was noted that the study report lacked a number of important details (specifically regarding the test material, such as the expiry date), however the study was conducted in accordance with EC and OECD test guidelines, and in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
C,C'-azodi(formamide)
EC Number:
204-650-8
EC Name:
C,C'-azodi(formamide)
Cas Number:
123-77-3
Molecular formula:
C2H4N4O2
IUPAC Name:
(E)-(carbamoylimino)urea; (Z)-(carbamoylimino)urea
Details on test material:
- Name of test material (as cited in study report): Unifoam AZ SO-NL
- Substance type: yellow powder
- Physical state: solid
- Analytical purity: 100%
- Impurities (identity and concentrations): none reported
- Lot/batch No.: Not reported.
- Expiration date of the lot/batch: Not reported.
- Stability under test conditions: Not reported.
- Storage condition of test material: Ambient temperature, in the dark.

Test animals

Species:
rat
Strain:
Crj: CD(SD)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River U.K. Limted, Margate, Kent, England
- Age at study initiation: four to six weeks
- Weight at study initiation: 113 to 146 gram
- Fasting period before study: overnight prior to thru 4 hours after dosing
- Housing: in groups, by sex, in metal cages with wire mesh floors
- Diet (e.g. ad libitum): standard rodent diet (Labsure LAD1) ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: nine days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 to 23 °C
- Humidity (%): 57%
- Air changes (per hr): 15 air changes/hour
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: To: No data

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: methylcellulose
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 25% w/v concentration

MAXIMUM DOSE VOLUME APPLIED: 20.0 ml/kg
Doses:
5 g/kg
No. of animals per sex per dose:
5 males, 5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 Days
- Frequency of observations and weighing:Animals were observed soon after dosing and at frequent intervals for the remainder of Day 1 (a period of five hours). On subsequent days the animals were observed once in the morning and again at the end of the experimental day. This latter observation was at approximately 16.30 hours on week days or 11.30 hours on Saturday and Sunday. Clinical signs were recorded at each observation.
- Necropsy of survivors performed: yes
- Other examinations performed: All animals on the main study were killed on Day 15 by cervical dislocation and were subjected to a macroscopic post mortem examination which consisted of opening the abdominal and thoracic cavities. The macroscopic appearance of abnormal organs when present was recorded.

Results and discussion

Preliminary study:
Results of the preliminary study indicated that the acute lethal oral dose of Unifoam AZ SO-NL was greater that 5.0 g/kg bodyweight. One group of ten rats (five males and five females) was dosed at 5.0 g/kg to confirm the result of the preliminary study.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
no mortality
Clinical signs:
Pilo-erection and abnormal body carriage (hunched posture) were observed in all rats within five minutes of dosing.
Pilo-erection alone persisted throughout the remainder of Day 1.
There were no other clinical signs and recovery, as judged by external appearance and behaviour, was complete by Day 2.
Body weight:
Slightly low bodyweight gains were recorded on Day 8 for two males and one female rat.
Other rats achieved anticipated bodyweight gains throughout the study.
Gross pathology:
Terminal autopsy findings were normal.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute lethal oral dose to rats of Unifoam AZ SO-NL was found to be greater than 5.0 g/kg bodyweight.
Executive summary:

An acute oral toxicity test was performed to determine the acute toxicity by oral exposure of the test substance AZ SO-NL. The study was conducted in accordance with relevant EC and OECD test guidelines, and in compliance with GLP (HLS 1988, 88720D/OCI 64/AC).

A group of ten rats (five male and five female) were dosed with 5000 mg test substance/kg bodyweight by oral gavage, then observation for mortality and clinical signs performed over a period of 14 days. At the end of the observation period, all animals were sacrificed and postmortem examinations performed.

No deaths occured in the test rats. Piloerection and hunched posture were seen in all rats within five minutes of dosing, and piloerection persisted for the remainder of the day of dosing; all animals had recovered by day 2 and no further unusual clinical signs were seen. Slightly low bodyweight gains were recorded for two male and one female rat, however all other rats made the anticipated weight gains. Terminal autopsy findings were normal.

The acute lethal oral dose to rats of Unifoam AZ SO-NL was found to be greater than 5.0 g/kg bodyweight.