Registration Dossier

Administrative data

Endpoint:
neurotoxicity
Remarks:
acute
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Secondary literature; no details available

Data source

Reference
Reference Type:
review article or handbook
Title:
The Neurotoxicity of Alcohols
Author:
Shoemaker WJ
Year:
1981
Bibliographic source:
Neurobehav Toxicol Teratol 3: 431-436

Materials and methods

Principles of method if other than guideline:
Neurotoxic effects in rats after i.p. injection
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
no details

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male
Details on test animals and environmental conditions:
bw 250-350 g
no further details

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
not specified
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
once
Frequency of treatment:
single injection
Doses / concentrations
Remarks:
Doses / Concentrations:

Basis:
no data
No. of animals per sex per dose:
no data
Details on study design:
no details

Examinations

Observations and clinical examinations performed and frequency:
no details
Specific biochemical examinations:
no data
Neurobehavioural examinations performed and frequency:
The intoxicating score is obtained by injecting different doses of the test substance i.p. into male Sprague-Dawley rats. The rating scale runs from 0-normal, 1-sedation, 2,3,4-increasing levels of ataxia, 5-loss of righting reflex, 6-coma, to 7-death.
The ED3 is defined as the dose to obtain a score of 3 on the intoxication scale.
Sacrifice and (histo)pathology:
no data

Results and discussion

Results of examinations

Details on results:
No further details available. For comparison: ED3 for ethanol was 1500 mg/kg bw

Effect levels

Dose descriptor:
other: ED3
Effect level:
2 000 other: mg/kg bw
Sex:
male
Basis for effect level:
other: The maximal response was obtained in 5 to 15 minutes; original value: 19.3 mmol/kg bw
Remarks on result:
other:

Applicant's summary and conclusion

Conclusions:
2000 mg/kg bw i.p. resulted in a mid level of ataxia but no loss of righting reflex
Executive summary:

Secondary literature, no details available.

In male Sprague-Dawley rats single i.p. injection of 2000 mg/kg bw resulted in a mid level of ataxia but no loss of righting reflex.