Aziridine

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Non-GLP near-guideline study, acceptable for assessment.

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1967

Report date:

1967

Reference 2

Reference Type:

other company data

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

BASF Test. In principle, the methods described in OECD Guideline 401 were used.
Rats were treated by gavage with preparations of the test substance. Group-wise documentation of clinical signs was performed over the 14-day study period. Body weight was determined before the start of the study only, as it was needed for determination of dose. The clinical signs and findings were reported in summary form.

GLP compliance:

no

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Ethylenimine

IUPAC Name:

Ethylenimine

Details on test material:

- Name of test material (as cited in study report): "Aethylenimin, rein"
- Physical state: liquid
- Analytical purity: pure.

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: not reported.

ENVIRONMENTAL CONDITIONS
- not reported

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 0.1 %; freshly prepared.

MAXIMUM DOSE VOLUME APPLIED:
- not reported.

Doses:

Doses not reported

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: Weighing was performed only at the beginning of the study for dose calculation. Observation of clinical signs was performed several times on the day of administration and once daily afterwards with the exception of weekends and on holidays.
- Necropsy of survivors performed: yes

Statistics:

LD 50 calculation according to Litchfield and Wilcoxon.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

4.814 mg/kg bw

95% CL:

4.02 - 5.78

Remarks on result:

other: Calculated using the denisty of 0.83 g/cm³, original specification: 5.8 µL/kg b.w.

Mortality:

Not reported in detail. Late deaths were observed until 14 days after application of the test substance. Surviving animals recovered within 10 to 14 days.

Clinical signs:

other: Male rats seemed to be more sensitive. On the day of experiment, no symptoms were observed. On the following days, increased urine secretion, apathy, abdominal position and food refusal were observed.

Gross pathology:

Dissection showed intestinal irritations, hyperemia of medulla renalis and necrosis of medulla renalis and of renal papillae.