Urea, reaction products with formaldehyde and glyoxal

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

27.09.1972 - 03.10.1972

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 study was conducted according to an internal BASF method which in principle is comparable to the OECD Guideline 401.
A test group consisting of 5 animals/sex was treated by single gavage with an aqueous solution of the test substance.
The animals were observed for mortality and for clinical symptoms of toxicity. At the end of the observation period, the surviving animals were sacrificed for the purpose of necropsy; animals that died during the observations period also were subjected to necropsy.

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

GLP compliance:

no

Test type:

standard acute method

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:

rat

Strain:

other: Gassner

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 255 (225-283) g males; 185 (154-204) g females

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 2-30%
- Amount of vehicle: 1.54 - 5.55 cm3/animal

Doses:

232, 1856, 3712 and 7424 mg/kg b.w. (= approx. 200, 1600, 3200, 6400 mm3/kg; density of the 45% solution = 1.16 mg/mm3; density of the pure TS = 1.36 mg/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 only prior to application
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

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.

Effect levels 2

Sex:

male/female

Dose descriptor:

LD0

Effect level:

>= 7 424 mg/kg bw

Remarks on result:

other: Calculated for a concentration of 100% test substance, the LD0 is >= 3341 mg/kg b.w.

Mortality:

not reported

Clinical signs:

other: not reported

Gross pathology:

nothing abnormal found

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

No classification according to GHS criteria.