Registration Dossier

Administrative data

Endpoint:
acute toxicity: other routes
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: No OECD guideline or GLP defined, acceptable restrictions (incomplete documentation); irrelevant route of exposure.
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1971
Report Date:
1971

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
other: single application of the test substance in a 2 % solution in water (v/v), observation time: 7 d (no further information)
GLP compliance:
no
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:
mouse
Strain:
other: Kisslegg
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: mean 29.2 g (male); 26.1 g (female)

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
water
Doses:
50, 64, 80, 100, 125, 160 or 200 mm³/kg bw (2 % solution in water v/v)
No. of animals per sex per dose:
10 male/10 female
Control animals:
no
Details on study design:
- Duration of observation period following administration: 13 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, gross pathology
Statistics:
Probit analysis based on Finney.

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
115 other: mm³/kg bw
Based on:
test mat.
95% CL:
105 - 127
Sex:
male
Dose descriptor:
LD50
Effect level:
107 other: mm³/kg bw
Based on:
test mat.
95% CL:
94 - 123
Sex:
female
Dose descriptor:
LD50
Effect level:
123 other: mm³/kg bw
Based on:
test mat.
95% CL:
109 - 140
Mortality:
200 mm³/kg bw: 10/10 males and 10/10 females;
160 mm³/kg bw: 8/10 males and 6/10 females;
125 mm³/kg bw: 5/10 males and 7/10 females;
100 mm³/kg bw: 6/10 males and 3/10 females;
80 mm³/kg bw: 3/10 males and 0/10 females;
64 mm³/kg bw: 0/10 males and 0/10 females;
50 mm³/kg bw: 0/10 males and 0/10 females
Clinical signs:
All dose groups: dyspnea, spastic gait. The clinical signs were reversible 12 days post application.
Gross pathology:
Abnormalities noted at necropsy of decedents were intestinal atony and congestion in the liver. In animals necropsied at the end of the study, abdominal adherences were observed.

Any other information on results incl. tables

At BASF’s Department of Toxicology, acute toxicity testing was performed according to published methods, which were adapted and standardized for the specific needs of the company, well before Test Guidelines for these methods were established by the OECD beginning 1982. These methods were comparable to the Union Carbide (now a DOW company) range finding toxicity data which have been published in the early toxicological literature (1944-1949). The results of these studies were reported until the early 1980s in summary reports called „Ergebnis der gewerbetoxikologischen Vorprüfung“ or „Toxikologische Grundprüfung“, which do not present details of the methods used, but focus on a summary presentation of the results.

Applicant's summary and conclusion