2-hexyloxyethanol

Acute Toxicity: other routes

Administrative data

Endpoint:

acute toxicity: other routes

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1989

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted as per compliance to Good Laboratory Practices TSCA Standards; Federal Register 48(230): 5397-53944, November 29, 1983.

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

other:

Principles of method if other than guideline:

not applicable

GLP compliance:

yes

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-hexyloxyethanol

EC Number:

203-951-1

EC Name:

2-hexyloxyethanol

Cas Number:

112-25-4

Molecular formula:

C6H13OCH2CH2OH

IUPAC Name:

2-hexyloxyethanol

Details on test material:

- Name of test material (as cited in study report): Ethylene Glycol Monohexyl Ether (EGHE)
- Physical state: clear liquid
- Analytical purity: 98.5% by gas chromatography
- Impurities (identity and concentrations): not specified
- Composition of test material, percentage of components: not specified
- Isomers composition: not specified
- Purity test date: not specified
- Lot/batch No.: S-020773/BRRC No. 50-383
- Expiration date of the lot/batch: not specified
- Radiochemical purity (if radiolabelling): 97.2% by thin layer chromatography and 99% by gas chromatography
- Specific activity (if radiolabelling): 2.1 mCi/mmole, which is equivalent to 31.88 x 10(6) DPM/mg.
- Locations of the label (if radiolabelling): 14C-labelled EGHE was synthesized by DuPont/New England Nuclear Products, Boston, MA
- Expiration date of radiochemical substance (if radiolabelling): not specified
- Stability under test conditions: stated to be stable in the Material Safety Data Sheet; stability studies at BRRC showed EGHE to be stable in physiological saline solution
- Storage condition of test material: The chemical was stored at ambient temperatures throughout the course of the study

Test animals

Species:

rat

Strain:

Fischer 344

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Sprague Dawley, Inc.
- Age at study initiation: 11-12 weeks old
- Weight at study initiation: not specified
- Fasting period before study: not specified
- Housing: not specified
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): standard conditions
- Humidity (%): standard conditions
- Air changes (per hr): standard conditions
- Photoperiod (hrs dark / hrs light): 12-hour light/darkcycle

Administration / exposure

Route of administration:

intravenous

Vehicle:

unchanged (no vehicle)

Details on exposure:

single dose

Doses:

Males: 25, 50 and 100 mg/kg
Females: 37.5, 75 and 150 mg/kg

No. of animals per sex per dose:

5 males + 5 females/dose

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: weekly on days 7 and 14
- Necropsy of survivors performed: not specified

Statistics:

standard descriptive statistics was used

Results and discussion

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

53.589 mg/kg bw

95% CL:

36.23 - 79.27

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

69.977

95% CL:

47.31 - 103.51

Mortality:

Males:
25 mg/kg - 0/5
50 mg/kg - 2/5
100 mg/kg - 6/6
Females:
37.5 mg/kg - 0/5
75 mg/kg - 3/5
150 mg/kg - 5/5

Clinical signs:

A necrotic condition of the tail distal to the injection site was observed in several male and female rats. Death was rapid, usually on the order of minutes, and was often preceded by staggering, then ataxia with labored breathing. Survivors frequently displayed slight disorientation, but recovered rapidly.

Body weight:

Moderate weight gains were observed in males and females during the 14-day observation period, although weight gains appeared to be smaller in males given 50 mg/kg EGHE relative to the 25 mg/kg group.

Gross pathology:

no data

Other findings:

not applicable

Any other information on results incl. tables

none

Applicant's summary and conclusion

Conclusions:

Based on the results of the study, the LD50 of EGHE via intravenous route to male rats was 53.589 mg/kg (36.23-79.27 mg/kg) and for female rats was 69.977 mg/kg (47.31-103.51 mg/kg)

Executive summary:

In this acute study via intravenous route, groups of male and female Fischer 344 rats were injected with undiluted Ethylene Glycol hexyl Ether (EGHE) at doses ranging from 25 -150 mg/kg and observed for a period of 14 days. A necrotic condition of the tail distal to the injection site was observed in several male and female rats. Death was rapid, usually on the order of minutes, and was often preceded by staggering, then ataxia with labored breathing. Survivors frequently displayed slight disorientation, but recovered rapidly. Moderate weight gains were observed in males and females during the 14-day observation period, although weight gains appeared to be smaller in males given 50 mg/kg EGHE relative to the 25 mg/kg group.Based on the results of the study, the LD50 of EGHE via intravenous route to male rats was 53.589 mg/kg (36.23-79.27 mg/kg) and for female rats was 69.977 mg/kg (47.31-103.51 mg/kg)