2-[(3-aziridin-1-ylpropionyl)methyl]-2-ethylpropane-1,3-diyl bis(aziridine-1-propionate)

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:

test procedure in accordance with national standard methods with acceptable restrictions

Remarks:

no detailed information on conduct of the study available; purity of the test substance not specified

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1977

Report date:

1977

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

- Principle of test: The test substance was applied via stomach intubation (single dose). No further details on the conduct of the study available.
- Short description of test conditions: no information availble
- Parameters analysed / observed: mortality, clinical signs, body weight changes, gross pathology of died animals and survivors

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Pentaerythritol tris(3-aziridin-1-ylpropionate)

EC Number:

260-568-2

EC Name:

Pentaerythritol tris(3-aziridin-1-ylpropionate)

Cas Number:

57116-45-7

Molecular formula:

C20H33N3O7

IUPAC Name:

3-[(3-aziridin-1-ylpropanoyl)oxy]-2-{[(3-aziridin-1-ylpropanoyl)oxy]methyl}-2-(hydroxymethyl)propyl 3-aziridin-1-ylpropanoate (non-preferred name)

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Lot/batch No. of test material: 03788

Test animals

Species:

rat

Strain:

Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: testing facility
- Age at study initiation: 3 - 4 weeks
- Weight at study initiation: 90 - 120 g
- Fasting period before study: no
- Diet: Wayne diet, ad libitum
- Water: ad libitum

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 8 mL/kg bodyweight

Doses:

8, 4 and 2 mL/kg body weight (corresponding to approx. 9264, 4632 and 2316 mg/kg body weight; based on a density of 1.158 g/mL (lit.))

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: not specified
- Frequency of observations and weighing: not specified
- Necropsy of survivors performed: yes + necropsy of died animals

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

4.92 mL/kg bw

Remarks on result:

other: corresponding to approx. 5697 mg/kg bodyweight (based on the density of 1.158 g/mL (lit.))

Mortality:

- in the 8 mL/kg bw group 5/5 animals died (4 on 1st day and 1 after 5 days)
- in the 4 mL/kg bw group 1/5 animals died (on 1st day)
- in the 2 mL/kg bw group no mortality was observed

Clinical signs:

other: - 8 mL/kg bw group: sluggish, slow breathing 15 min; prostrate 1.5 h - 4 mL/kg bw group: sluggish, slow breathing 30 min; piloerection, legs stiffened within 2 h; prostrate at 2.5 h; convulsions, foaming at mouth at 4 h - 2 mL/kg bw group: sluggish, slow

Gross pathology:

- in died animals petechial hemorrhages and congestion in the lungs; livers burned; livers, spleens and kidneys mottled; kidneys pale; adrenals congested; stomachs distended, containing a hard mass, opaque and gas-filled; intestines opaque, gas-filled and yellow
- nothing remarkable in survivors

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met