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:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

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

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Three groups of 5 female SD rats were exposed to 100, 215, and 464 mg/kg bw via i.p. and mortality was determined for 7 days.
GLP compliance:
no
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Specific details on test material used for the study:
- Description: Clear liquid (super saturated)

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: 121 - 172 g
- Fasting period before study: overnight

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
ethanol
Details on exposure:
100 and 215 mg/kg bw: 25% in ethanol
464 mg/kg bw: undiluted
Doses:
100, 215, 464 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days
- Frequency of observations: Observations for mortality and signs of effects were made immediately after dosing at one, four, and 24 hours, and once daily thereafter
- Necropsy of survivors performed: yes
Statistics:
Mortality data was analyzed statistically, utilizing the tables of Horn H.J., Biometrics 12, 311, 1956

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
271 mg/kg bw
Based on:
test mat.
95% CL:
>= 167 - <= 441
Mortality:
100 mg/kg bw: No mortality was observed
215 mg/kg bw: Two animals died within 1 day
464 mg/kg bw: Two animals died within 1 day. Two other animals died one day later.
Clinical signs:
100 mg/kg bw: None
215 mg/kg bw: One of the animals who died exhibited slightly depressed behavior. This animal was also stained on the body fur with urine, which indicates a lack of normal preening.
464 mg/kg bw: One animal who died was prostrate.
Gross pathology:
100 mg/kg bw: None
215 mg/kg bw: The two animals who were found dead exhibited expected effects of their stages of autolysis
464 mg/kg bw: Two animals exhibited yellow coloration in the large intestines and another exhibited a lighter coloration of the brain than would normally be expected. All other animals in the study exhibited no remarkable effects.

Applicant's summary and conclusion