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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: No OECD guideline or GLP defined, acceptable restrictions (incomplete documentation).
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report Date:
1977

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
other: 10 males, single oral application by gavage of undiluted test substance, observation time: 14 d
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
- Name of test material: Benzylamin

Test animals

Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Winkelmann
- Weight at study initiation: 160 - 180 g

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
0.8; 1.0; 1.2; 1.3; 1.5 mL/kg bw
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: no
Statistics:
LD50 calculation according to Fink and Hund.

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
ca. 1.15 mL/kg bw
Based on:
test mat.
95% CL:
1.05 - 1.25
Remarks on result:
other: corresponding to 1127 mg/kg bw
Mortality:
1.5 mL/kg bw: 10/10;
1.3 mL/kg bw: 6/10;
1.2 mL/kg bw: 6/10;
1.0 mL/kg bw: 3/10;
0.8 mL/kg bw: 0/10
Clinical signs:
Diarrhea, sedation, respiratory disorders and tonical cramps.
Body weight:
A reduction in the bodyweight development was observed.

Any other information on results incl. tables

The LD50 of 1.15 mL/kg bw corresponds to approx. 1127 mg/kg bw.

Applicant's summary and conclusion