Propyloxirane

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: guideline study (according to OECD 401)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Propyloxirane

EC Number:

213-701-3

EC Name:

Propyloxirane

Cas Number:

1003-14-1

Molecular formula:

C5H10O

IUPAC Name:

2-propyloxirane

Details on test material:

- Name of test material (as cited in study report): n-Pentenoxid-1,2
- Physical state: colourless, liquid
- Analytical purity: 99.9%
- Substance No.: 81/355
- Storage condition of test material: keep cool

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Dr. Thomae
- Age at study initiation: ca. 12 weeks
- Weight at study initiation: mean(males): 200 g; mean(females): 198 g
- Fasting period before study: 16 hrs (but: water ad libitum)
- Housing: 5 animals/cage
- Diet: Ssniff R (Ssniff)
- Water: VE-water (weekdays) or tap water (weekend/holidays) ad libitum
- Acclimation period: at least 1 week


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-26
- Humidity (%): 45-75
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 10, 14.7, 21.5, 31.6%
- Justification for choice of vehicle: aqueous formulation, according to the physiological medium
- Purity: 0.5% (aqueous solution)


MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg

Doses:

1000, 1470, 2150, 3160 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: clinical signs: <15 min, 15 min, 30 min, 1 h, 2 h, 4 h 5 h after substance application, than: 1x daily (weekdays); moribund and dead animals: 2x (weekdays), 1x (holidays); weighing: before substance application (in groups), 3 days, 7 days, 13 days after the application
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

1 460 mg/kg bw

95% CL:

> 1 210 - < 1 750

Remarks on result:

other: statistical evaluation

Effect levels 2

Sex:

male

Dose descriptor:

LD50

Effect level:

1 620 mg/kg bw

95% CL:

> 1 090 - < 2 270

Remarks on result:

other: statistical evaluation

Effect levels 3

Sex:

female

Dose descriptor:

LD50

Effect level:

ca. 1 327 mg/kg bw

Remarks on result:

other: statistical evaluation (interpolation)

Mortality:

- 1000 mg/kg: 1/10 (male); - 1470 mg/kg: 5/10 (1 male, 4 females); - 2150 mg/kg: 9/10 (4 males, 5 females); - 3160 mg/kg: 10/10 (5 males, 5 females); animals died within 1 day after application

Clinical signs:

other: - dyspnoe, apathy, abnormal position, staggering, atonia, loss of pain reflex, loss of cornea reflex, narcotic condition, scrubby fur, diarrhoea, cyanosis, exsiccosis, bad general condition (15 min-3 days after application)

Gross pathology:

Dead and sacrificed animals: organs without abnormalities

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Remarks:

Migrated information