Urea, reaction products with formaldehyde and glyoxal

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

23. - 31.08.1972

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study well documented, acceptable for assessment

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1973

Report date:

1973

Reference 2

Reference Type:

secondary source

Title:

Unnamed

Year:

1973

Materials and methods

Principles of method if other than guideline:

BASF test
The inhalation risk test (IRT) was performed in principle as described in OECD Guideline 403. The aim of the test was to demonstrate the toxicity of an atmosphere saturated with vapors of the volatile components of the test substance at a temperature chosen for vapor generation (i.e. 20 °C for the present test substance).
The animals were exposed to the test substance for 8 hours (flow-through, 200 liters/hour). The treatment was followed by an observation period of 7 days.

GLP compliance:

no

Test type:

other: IHT (Inhalation hazard test)

Test material

Test material information

Constituent 1

Details on test material:

- CAS number (as cited in study report): 1854-26-8
- Name of test material (as cited in study report): Fixapret CPN, Dimethylolglyoxalmonourein
- Substance type: aqueous solution
- Physical state: liquid
- Purity: 45%
- Impurities (identity and concentrations): 0.5 -0.8% formaldehyde

Test animals

Species:

rat

Strain:

other: Siv

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Mean weight at study initiation: 552-566 g males; 518-530 g females

Administration / exposure

Route of administration:

inhalation: vapour

Type of inhalation exposure:

whole body

Vehicle:

other: unchanged (no vehicle)

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Rate of air: 200 l
- Method of conditioning air: Vapours were generated by bubbling air through a column of about 5 cm above a fritted glass disc in a glass cylinder.
- Temperature air chamber: 20°C


TEST ATMOSPHERE
- Brief description of analytical method used: Inhalation hazard test
- Samples taken from breathing zone: no

Analytical verification of test atmosphere concentrations:

no

Remarks:

The nominal concentration can be calculated as quotient of the amount of test substance weight loss during the exposure and the amount of air used during the exposure.

Duration of exposure:

8 h

Concentrations:

6.925 (6.913-6.938) mg/l

No. of animals per sex per dose:

6

Control animals:

yes

Details on study design:

- The test was performed in two trials on two consecutive days under identical conditions with 6 animals per trial
- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: daily observations for clinical signs; weighing prior to application and at the end of the observation period
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LC0

Effect level:

> 9.93 mg/L air

Exp. duration:

8 h

Remarks on result:

other: No mortality due to exposition to test substance vapour within 8 hours.

Mortality:

not observed

Clinical signs:

other: At the start of the test (not explained in detail), partly bloody secretion of eyes and noses, aqueous secretion of the eyes, evident irritation of noses and eyes and accelerated thoracic respiration were observed.

Body weight:

body weight gain: males 63-65 g; females 70-71 g

Gross pathology:

nothing abnormal detected

Any other information on results incl. tables

Negative Control: all 6 animals survived the exposition of 8 hrs to air and the observation period of 7 d. No clinical signs and gross abnormalities were observed.

Applicant's summary and conclusion

Conclusions:

Irritating effects on mucous membrans.