2,3-epoxypropan-1-ol

Repeated dose toxicity: inhalation

Administrative data

Endpoint:

short-term repeated dose toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

Not documented

Reliability:

3 (not reliable)

Rationale for reliability incl. deficiencies:

other: Significant methodological deficiences. Exposure to one dose only.

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:

publication

Title:

The toxicology of glycidol and some glycidyl ethers

Author:

Hine, C.H. et al.

Year:

1956

Bibliographic source:

Arch. Ind. Health 14, 250-264 (1956)

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Rats were exposed to the test substance at one concentration for 50 days via inhalation route.

GLP compliance:

not specified

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

2,3-epoxypropan-1-ol

EC Number:

209-128-3

EC Name:

2,3-epoxypropan-1-ol

Cas Number:

556-52-5

Molecular formula:

C3H6O2

IUPAC Name:

(oxiran-2-yl)methanol

Details on test material:

- Name of test material (as cited in study report): Glycidol
- Molecular weight (if other than submission substance): 74.05
- Physical state: Liquid

Test animals

Species:

rat

Strain:

Long-Evans

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Gilroy Laboratories, California.
- Age at study initiation: Not documented
- Weight at study initiation: Not documented
- Fasting period before study: Not documented
- Housing: Housed 2 to a cage
- Diet (e.g. ad libitum): Special green powdered feed which afforded optimum nutritional conditions.
- Water (e.g. ad libitum): Not documented
- Acclimation period: Not documented

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not documented
- Humidity (%): Not documented
- Air changes (per hr): Not documented
- Photoperiod (hrs dark / hrs light): Not documented

IN-LIFE DATES: From: To: Not documented

Administration / exposure

Route of administration:

inhalation

Type of inhalation exposure:

whole body

Vehicle:

not specified

Remarks on MMAD:

MMAD / GSD: No information provided

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Exposure chambers of 200 litre capacity
- Method of holding animals in test chamber: Not documented
- Source and rate of air: The constant metering device delivered the substance in measured amounts to the evaporator, where they were vapourized in the air entering the chamber. The air in the chamber was allowed to equilibrate to a theoretical 95 to 99% of the desired concentration before the animals were introduced.
- Method of conditioning air: Not documented
- System of generating particulates/aerosols: Not documented
- Temperature, humidity, pressure in air chamber: Not documented
- Air flow rate: 11.7 to 22 L/min.
- Air change rate: 3.5 to 6.6 air changes per hour.
- Method of particle size determination: Not documented
- Treatment of exhaust air: Not documented

TEST ATMOSPHERE
- Brief description of analytical method used: Vapour concentrations were monitored by frequent analysis of air drawn from a sampling port and absorbed in a magnesium chloride and hydrochloric acid solution.
- Samples taken from breathing zone: no data

Analytical verification of doses or concentrations:

yes

Details on analytical verification of doses or concentrations:

Vapour concentrations were monitored by frequent analysis of air drawn from a sampling port and absorbed in a magnesium chloride and hydrochloric acid solution.

Duration of treatment / exposure:

10 weeks

Frequency of treatment:

5 days/week, 7 h/day

Doses / concentrations

Remarks:

Doses / Concentrations:
400 ppm
Basis:

No. of animals per sex per dose:

No information provided

Control animals:

yes

Details on study design:

Post-exposure period: no data
Control animals received untreated air.

Positive control:

No information provided

Examinations

Observations and examinations performed and frequency:

CAGE SIDE OBSERVATIONS: Yes

DETAILED CLINICAL OBSERVATIONS: Yes

BODY WEIGHT: Yes

FOOD CONSUMPTION:
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No data

FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No data

WATER CONSUMPTION: No data

OPHTHALMOSCOPIC EXAMINATION: No data

HAEMATOLOGY: Yes
- Time schedule for collection of blood: No data
- Anaesthetic used for blood collection: No data
- Animals fasted: No data
- How many animals: No data
- Parameters checked: Haemoglobin

CLINICAL CHEMISTRY: No data
- Time schedule for collection of blood: No data
- Animals fasted: No data
- How many animals: No data
- Parameters checked in table [No.?] were examined. No data

URINALYSIS: No data
- Time schedule for collection of urine: No data
- Metabolism cages used for collection of urine: No data
- Animals fasted: No data
- Parameters checked in table [No.?] were examined. No data

NEUROBEHAVIOURAL EXAMINATION: No data
- Time schedule for examinations: No data
- Dose groups that were examined: No data
- Battery of functions tested: sensory activity / grip strength / motor activity / other: No data

Sacrifice and pathology:

GROSS PATHOLOGY: Yes - lungs, Iivers, and kidneys of all animals were freed of connective tissue and excess moisture and weighed for determination of organ/body weight ratios.
HISTOPATHOLOGY: Yes - brain, thyroid, thymus, heart, stomach, intestine, pancreas, adrenal, testis, and bladder as well as sections from the tissues taken in gross pathological examinations.

Other examinations:

Organ/body weight ratios, percentage weight gain and haemoglobin concentrations were examined.

Statistics:

Organ/body weight ratios, percentage weight gain and haemoglobin concentrations were compared with those of the controls using the Student t-test.

Results and discussion

Results of examinations

Clinical signs:

no effects observed

Mortality:

no mortality observed

Body weight and weight changes:

effects observed, treatment-related

Food consumption and compound intake (if feeding study):

not specified

Food efficiency:

not specified

Water consumption and compound intake (if drinking water study):

not specified

Ophthalmological findings:

not specified

Haematological findings:

effects observed, treatment-related

Clinical biochemistry findings:

not specified

Urinalysis findings:

not specified

Behaviour (functional findings):

not specified

Organ weight findings including organ / body weight ratios:

effects observed, treatment-related

Gross pathological findings:

effects observed, treatment-related

Histopathological findings: non-neoplastic:

effects observed, treatment-related

Histopathological findings: neoplastic:

not specified

Details on results:

No lethality, slight retardation of weight gain, necropsy revealed no gross histopathological lesions, slight decrease of peritoneal fat, no effect on organ weights, slightly increased hemoglobin concentration.

Effect levels

Dose descriptor:

NOAEC

Effect level:

400 ppm

Based on:

not specified

Sex:

male/female

Basis for effect level:

other: Only dose level tested.

Target system / organ toxicity

Critical effects observed:

not specified

Any other information on results incl. tables

No lethality, slight retardation of weight gain, necropsy revealed no gross histopathological lesions, slight decrease
of peritoneal fat, no effect on organ weights, slightly increased hemoglobin concentration.

Applicant's summary and conclusion

Conclusions:

In this 50-day inhalation toxicity study with glycidol in rats no mortality, no effect on organ weights and no gross histopathological lesions occured. A slight decrease of peritoneal fat, slightly increased hemoglobin concentration and slight retardation of weight gain were observed.

Executive summary:

In a study conducted in 1956 by Hines et al, the test substance was examined for its ability to cause toxicity when administered to male Long-Evans for a testing period of 50 days. The test animals were exposed to the test substance 7 hours per day, 5 days per week for 50 days via the inhalation route. The test substance was admininstered at a concentration of 400ppm. The test animals were observed during exposure and gross and histopathological examinations were conducted following exposure. Following exposure, no mortality, no effect on organ weights and no gross histopathological lesions occured. A slight decrease of peritoneal fat, slightly increased hemoglobin concentration and slight retardation of weight gain were observed.