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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:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: meets generally accepted criteria

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1956
Report Date:
1956

Materials and methods

Principles of method if other than guideline:
Method: groups of 5 male rats were given single oral doses of 1.0, 2.15, 4.64, 10.0 or 21.5 g/kg bw and observed for 7 days, gross autopsy.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Purity was considered to be 100 %.

Test animals

Species:
rat
Strain:
not specified
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 175 g
- Fasting period before study: 4 hours
- Housing: in groups
- Diet ad libitum
- Water ad libitum

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
testsubstance was given as 10 % or 20 "% or 70 % solution
Doses:
1000 mg/kg bw, 2150 mg/kg bw, 4640 mg/kg bw, 10000 mg/kg bw, 21500 mg/kg bw given as 10 % or 20 "% or 70 % solution.
No. of animals per sex per dose:
5 males
Control animals:
no
Details on study design:
Food was withheld from rats for a period of 4 hours; rats were observed for 7 days post treatment and gross signs of toxicity were noted, gross autopsy was performed upon rats that died and of the surviving rats at the end of the observation period
Statistics:
moving average method of Weil (1952)

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
ca. 14 700 mg/kg bw
Based on:
other: clinical signs of intoxication from 2150 mg/kg bw onwards and mortality rate at the highest test dose (21500 mg/kg bw) of 5/5 male rats within 24 hours
Mortality:
only at the highest test dose of 21500 mg/kg bw: 5/5 rats died within 24 hours post treatment
no other rat died
Clinical signs:
1000 mg/kg bw : rats appeared normal throughout the observation period
2150 mg/kg bw, 4640 mg/kg bw, 10000 mg/kg bw, 21500 mg/kg bw:
rats appeared depressed, exhibited lacrimation, slow and laboured respiration,
ataxia, and other effects of the limbs
21500 mg/kg bw: additionally depressed and absent placing, righting and pain reflexes
at 43 hours post dosing the surviving rats recovered
Body weight:
no data
Gross pathology:
gross autopsy of the dead rats:
hyperemic and hemorrhagic lungs
irritation of the pyloric portion of the stomach, small intestine (distended and filled with a clear yellowish colored fluid)
and peritoneum, congested kidneys and adrenal
gross autopsy of the survivors #
1000 and 2150 mg/kg bw : rats showed no gross pathothololgical changes
4600 and 10000 mg/kg bw: rats showed hyperemic zones at the periphery of the medulla in the kidneys
Other findings:
Confidence limits could not be calculated due to the "all or none" response (no further data)

Any other information on results incl. tables

Within a couple of hours after the dose, the animals that received 2.15 g/kg or more showed signs of fatigue, slow respiration and ataxia. All the animals in the highest dose group died. Autopsies revealed kidney changes in the three
highest dose groups.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Executive summary:

5 male rats were given single oral doses of 1000, 2150, 4640 10000 or 21500 mg/kg bw and observed for 7 days. 1000 mg/kg bw was tolerated wihout any harm. Rats of the other groups appeared depressed, exhibited lacrimation, slow and laboured respiration, ataxia, and other effects of the limbs. 21500 mg/kg bw caused the death of all animals within 24 hours. Thus the LD50 value was determined 14700 mg/kg bw (Celanese Corporation 1956).