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Toxicological information

Acute Toxicity: oral

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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

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1967
Report Date:
1967
Reference Type:
other company data
Title:
Unnamed
Year:
2002
Report Date:
2002

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
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

Reference
Name:
Unnamed
Type:
Constituent
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 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:
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.
Body weight:
No reported.
Gross pathology:
Dissection showed intestinal irritations, hyperemia of medulla renalis and necrosis of medulla renalis and of renal papillae.

Applicant's summary and conclusion