Perhydropyrimidin-2-one

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

disregarded due to major methodological deficiencies

Reliability:

3 (not reliable)

Rationale for reliability incl. deficiencies:

other: Unsitable test system and significant methodological deficiencies (comparable to guideline study OECD 403 - Annex (1981), but solid substance, concentration in the air not quantifiable, only 7 days observation period)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1966

Report date:

1966

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Version / remarks:

Inhalation Hazard Test

Principles of method if other than guideline:

BASF-TEST: It demonstrates the toxicity of an atmosphere saturated with vapors of the volatile components of a test substance at the temperature chosen for vapor generation (usually 20°C). Young adult laboratory rats were purchased from breeder. Usually the source and strain of animals were not documented. Several groups of usually 3 rats per sex were sequentially exposed to the vapors, generated by bubbling 200 l/h air through a substance column of about 5 cm above a fritted disc in a glass cylinder for different time periods. The exposure time not causing lethality was usually tested twice. No analytical determination of the atmosphere concentrations was performed. The nominal concentration usually can be calculated as quotient of the amount of the test substance weight loss during exposure. Group-wise documentation of clinical signs was performed over the 7 day study period. Body weight of groups was determined before the start of the study and at the end of the observation period in surviving animals.

GLP compliance:

no

Remarks:

pre-GLP

Test type:

other: Inhalation Hazard Test

Test material

Test material information

Constituent 1

Reference substance name:

Propyleneurea

IUPAC Name:

Propyleneurea

Details on test material:

- Name of test material (as cited in study report): Propyleneurea
- Physical state: solid
- Purity: 97%

Test animals

Species:

rat

Strain:

not specified

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Mean body weight at study initiation:
IHT 20°C experiment 1: group weight 1055 g (6 animals)
IHT 20°C experiment 2: group weight 1157 g (6 animals)
IHT 100°C experiment 1: group weight 1237 g (6 animals)
IHT 100°C experiment 2: group weight 1112 g (6 animals)

Administration / exposure

Route of administration:

inhalation

Type of inhalation exposure:

whole body

Vehicle:

other: unchanged (no vehicle)

Analytical verification of test atmosphere concentrations:

no

Duration of exposure:

8 h

Concentrations:

IHT 20°C experiment 1 and 2: nominal concentration in the air 1.07 mg/L
IHT 100°C experiment 1 and 2: nominal concentration in the air 1.40 mg/L

No. of animals per sex per dose:

3 (in total 6 males and 6 females for IHT at 20°C and 6 males and 6 females for IHT at 100°C)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 7 days
- The animals were examined for mortality and clinical signs of toxicity
- Frequency of observations: several times at the application day and thereafter once each working day
- Body weights were recorded at the beginning and the end of the study
- Necropsy of survivors and animals which died performed: yes

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

other: IHT

Exp. duration:

8 h

Remarks on result:

other: 20°C; no mortality

Effect levels 2

Sex:

male/female

Dose descriptor:

other: IHT

Exp. duration:

8 h

Remarks on result:

other: 100°C; no mortality

Mortality:

No mortality

Clinical signs:

other: 20°C: no clinical signs 100°C: flight attempts at the beginning of exposure; after approx. 4 h slight irritation of mucous membranes

Body weight:

- Mean body weight at the end of the study:
IHT 20°C experiment 1: group weight 1241 g
IHT 20°C experiment 2: group weight 1298 g
IHT 100°C experiment 1: group weight 1407 g
IHT 100°C experiment 2: group weight not determined

Gross pathology:

Nothing abnormal detected.

Applicant's summary and conclusion

Conclusions:

No mortalities were observed. However, it is very likely that there was no/nearly no TS in the air.