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Toxicological information

Acute Toxicity: other routes

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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: Acceptable, well-documented publication which meets basic scientific principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

Principles of method if other than guideline:
Acute toxicity after intraperitoneal injection in mouse
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Vitamin A acetate (CAS No. 127-47-9) in arachis oil; according to the authors, purity was 1.53 mio IU/g (ca. 530 mg Vitamin A acetate/g or 53%); no further data

Test animals

Species:
mouse
Strain:
NMRI
Sex:
male/female

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
olive oil
Doses:
1780, 2150, 2610, 3160, 3830, 5620, 8250 mg/kg bw
No. of animals per sex per dose:
5-10
Control animals:
no
Details on study design:
Groups of male and female NMRI mice were given a single intraperitoneal  
dose of the test substance (as a 70% (w/v) suspension in olive oil) and  were 
observed for 14 days. Examinations included mortality (after 1, 24,  and 
48 hour(s), and after 7 and 14 days, signs of toxicity, and necropsy  of 
decedents and survivors sacrificed at the end of the observation  period.
Statistics:
Probit Analysis.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
2 390 mg/kg bw
Mortality:
see table
Clinical signs:
Signs of toxicity were observed at all dose levels and comprised dyspnea,  intermittent respiration, apathy, anomal position, staggering, tremors,  twitching, spastic gait, stretching, piloerection, exsiccosis,  encrustations at the snout and eyes, paresis, and poor general state.
Body weight:
There was no statistically significant effect on body weight.
Gross pathology:
Pathological examination revealed no findings.

Any other information on results incl. tables

Mortality after 14 days:

1780 mg/kg bw: 2/10 males; 1/10 females
2150 mg/kg bw: 4/10 males; 1/10 females
2610 mg/kg bw: 6/10 males; 8/10 females
3160 mg/kg bw: 9/10 males; 8/10 females
3830 mg/kg bw: 5/5 males; 5/5 females
5620 mg/kg bw: 5/5 males; 5/5 females
8250 mg/kg bw: 5/5 males; 5/5 females

Applicant's summary and conclusion