Ethylidynetrimethanol

Acute Toxicity: oral

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

Test material information

Constituent 1

Reference substance name:

Propylidynetrimethanol

EC Number:

201-074-9

EC Name:

Propylidynetrimethanol

Cas Number:

77-99-6

Molecular formula:

C6H14O3

IUPAC Name:

2-ethyl-2-(hydroxymethyl)propane-1,3-diol

Details on test material:

Purity was considered to be 100 %.

Test animals

Species:

rat

Strain:

not specified

Sex:

male

Details on test animals or test system 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:

other: 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 21

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

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).