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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1963
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Remarks:
The study was not compliant with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1963
Report Date:
1963

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Method: 6 male rats were dosed at 6 and 18 ml/kg by peroral intubation of the undiluted test substance. The observation period was 14 days.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
other: Carworth Farms-Eliss
Sex:
not specified
Details on test animals and environmental conditions:
TEST ANIMALS

- Source: The rats were reared at the Mellon Institute

- Age at study initiation: 5-6 weeks

- Weight at study initiation: 90-120g

- Fasting period before study: no

- Diet: Rockland complete rat diet

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 1.9ml

Doses:
16 and 8 ml/kg
No. of animals per sex per dose:
5M
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days

- Necropsy of survivors performed: yes
Statistics:
The method of moving average was used for calculating the median effective dose (LD50)

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
12.3 mL/kg bw
Remarks on result:
other: (9.98 to 15.3) ml/kg, undiluted.
Sex:
male
Dose descriptor:
LD50
Effect level:
11 685 mg/kg bw
Remarks on result:
other: calculated using density = 0.95
Mortality:
Most deaths occurred within the first several hours after dosing.
Clinical signs:
The animals were sluggish and unsteady in gait soon after dosing.
Body weight:
All surviving animals showed body weight gains between 57-81 grams.
Gross pathology:
At autopsy, gross examination revealed congested lungs, mottled livers with prominent acini and some haemorrhage and congestion of the gastrointestinal tract.

Any other information on results incl. tables

Table 1: Number of animals dead and time range within which mortality occurred

 

Dose
(ml/kg
bw)

Mortality (# dead/total)

Time range of deaths (days)

Male

Female

Combined

16.0

 4/5

 -

 4/5

 0,1

8.0

 0/5

 0/5

 -

 

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The acute oral LD50 of 12.3 ml/kg (11685 mg/kg) was determined for male rats in a reliable study conducted according to generally accepted scientific principles.