Registration Dossier

Toxicological information

Acute Toxicity: other routes

Currently viewing:

Administrative data

Endpoint:
acute toxicity: other routes
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: scientifically acceptable and sufficient documented

Data source

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

Materials and methods

Principles of method if other than guideline:
LD50 determination in dependance of the injection velocity. the examination of the acute intravenous toxicity was carried out with a 0.32 to 2.52 % aqueous solution and a constant application volume of 25 ml/kg in mice with different injection velocities between 4 and 60 seconds. symptoms of poisoning and mortality were observed during 1 hour after application of the test substance
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
benzyl alcohol pro analysi

Test animals

Species:
mouse
Strain:
other: CF1/W 68
Sex:
male
Details on test animals and environmental conditions:
male CF1/W 68 mice, SPF, avarage weight 16 - 22 g; husbandry: 5 animals per cage

Administration / exposure

Route of administration:
intravenous
Vehicle:
water
Doses:
80 to 630 µl/kg (ca. 83.6 to 658.4 µg/kg)
No. of animals per sex per dose:
10 male mice per dose
Control animals:
not specified
Details on study design:
no data
Statistics:
according Fink and Hund, Arzneimittelforschung (1965), 15, 624-630

Results and discussion

Effect levels
Dose descriptor:
LD50
Effect level:
ca. 105 mg/kg bw
Mortality:
see remarks on results including tables and figures; dead occured during injection and up to 1 minute after injection
Clinical signs:
cyanosis, prone position, exopthalmus and gasping
Body weight:
no data
Gross pathology:
no data
Other findings:
no data

Any other information on results incl. tables

injection velocity 4 seconds: LD50 = 105 µl/kg

injection velocity 8 seconds: LD50 = 186 µl/kg

injection velocity 15 seconds: LD50 = 242 µl/kg

injection velocity 30 seconds: LD50 = 395 µl/kg

injection velocity 60 seconds: LD50 = 514 µl/kg

injection velocity 4 seconds: LD 50 = 105 µl/kg

injection velocity 4 seconds: LD 50 = 105 µl/kg

Applicant's summary and conclusion

Executive summary:

method: LD50 determination in dependance of the injection velocity. the examination of the acute intravenous toxicity was carried out with a 0.32 to 2.52 % aqueous solution and a constant application volume of 25 ml/kg in mice with different injection velocities between 4 and 60 seconds. symptoms of poisoning and mortality were observed during 1 hour after application of the test substance

result: LD50 value depends on injection velocity; LD50 = 105 µl/kg (4 sec), LD50 = 186 µl/kg (8 sec), LD50 = 242 µl/kg (15 sec), LD50 = 395 µl/kg (4 sec), LD50 = 514 µl/kg (60 sec)

reference: Muermann (Bayer AG), 1977