Urea, reaction products with formaldehyde and glyoxal

Acute Toxicity: other routes

Administrative data

Endpoint:

acute toxicity: other routes

Type of information:

experimental study

Adequacy of study:

other information

Study period:

21.09. - 04.10.1972

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study meets generally accepted scientific principles.

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1973

Reference 2

Reference Type:

secondary source

Title:

Unnamed

Year:

1973

Materials and methods

Principles of method if other than guideline:

BASF test
The study was conducted according to an internal BASF method. Several groups of 5 mice per sex and dose were treated intraperitoneally with preparations of the test substance as 2-30% aqueous solution (w/v).
Each animal received a single intraperitoneal injection of test solution.
The animals were observed for mortality and for clinical symptoms of toxicity. At the end of the observation period of 7 days, the surviving animals were sacrificed for the purpose of necropsy; animals that died during the observation period also were subjected to necropsy.

The LD50 value was estimated on the basis of the observed mortalities.

GLP compliance:

no

Limit test:

no

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:

mouse

Strain:

other: Kisslegg

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Body weight at study initiation: 34-40 g males; 24-34 g females

Administration / exposure

Route of administration:

intraperitoneal

Vehicle:

water

Doses:

200, 1600, 3200, 6400 mm3/kg (= approx. 232, 1856, 3712, 7424 mg/kg; density of the 45% solution = 1.16 mg/mm3; density of the pure TS = 1.36mg/mm3)

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: daily observations for clinical signs; weighing prior to application
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Dose descriptor:

LD50

Effect level:

> 7 424 mg/kg bw

Remarks on result:

other: Calculated for a concentration of 100% test substance, the LD50 is > 3341 mg/kg b.w.

Mortality:

1 male of the 6400 mm3/kg treatment died within 24 hrs after application.

Clinical signs:

Directly after injection, all animals showed accelerated respiration. In the 200 and 1600 mm3/kg treatments, the signs were reversible withinone day. Animals of the 3200 and 6400 mm3/kg treatments showed squatting posture and atonia as additional clinical signs. All signs were reversible at least after 5 days.

Gross pathology:

200 and 1600 mm3/kg: nothing abnormal detected
3200 mm3/kg: indifferent liver borders in 1/10 animals; splenomegaly in 1/10 animals
6400 mm3/kg: indifferent liver borders, splenomegaly; 1 male had carcassed abdominal organs