2,3-epoxypropan-1-ol

Acute Toxicity: other routes

Administrative data

Endpoint:

acute toxicity: other routes

Type of information:

experimental study

Adequacy of study:

key study

Study period:

January 1979

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study well documented, meets generally accepted standard methods with acceptable restrictions.

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:

1979

Report date:

1979

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Chinese hamsters were administered the test substance over a range of concentrations to assess the toxicity following single administration of the test substance and 14 day observation period.

GLP compliance:

no

Remarks:

study prior to GLP settings

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Glycidol

IUPAC Name:

Glycidol

Details on test material:

Test substance: other TS: Glycidol (no further data)

Test animals

Species:

hamster, Chinese

Strain:

not specified

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Shell Research Limited, Sittingbourne Research Centre, Sittingbourne, Kent ME98AG, Grossbritannien.
- Age at study initiation: Approximately 3 months
- Weight at study initiation: between 30 and 35g.
- Fasting period before study: 16 hours prior to the start of the study
- Housing: Individually housed in Makrolon Cages (Type II).
- Diet (e.g. ad libitum): Rat food ad libitum, except 16 hours prior to the start of dosing.
- Water (e.g. ad libitum): Drinking water ad libitum
- Acclimation period: Not documented

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 0.5°C
- Humidity (%): 55 ± 5%
- 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:

intraperitoneal

Vehicle:

physiological saline

Details on exposure:

No information provided

Doses:

0.147, 0.215, 0.261 and 0.316 mL/kg bw

No. of animals per sex per dose:

2

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days, with 4 weeks follow-up post-exposure
- Frequency of observations and weighing: Not documented
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: Not documented

Statistics:

Litchfield and Wilcoxon

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

312 mg/kg bw

Mortality:

Deaths were observed within 48 hours of dosing.

Clinical signs:

Sedation, ataxia, tremor, dyspnoe, muscular hypotonia

Body weight:

No information provided

Gross pathology:

In the animals that died during the dosing period, the pale liver and haemorrhaging on the intestinal wall was observed. Surviving animals did not show any specific pathological findings.

Other findings:

No additional findings

Any other information on results incl. tables

No additional information

Applicant's summary and conclusion

Conclusions:

In this acute i.p. toxicity study with glycidol in hamsters the LD50 was 312 mg/kg bw.

Executive summary:

In a study conducted in 1979, the test substance, Glycidol was tested for its ability to cause toxicity in Chinese Hamsters when administered via intraperitoneal route. Glycidol was administered at concentrations of 0.147, 0.215, 0.261 and 0.316 mL/kg bw.

Mortalities were observed during the dosing period and symptoms including sedation, ataxia, tremor and muscular hypotonia were also observed. Under the conditions of this study, the LD₅₀ was determined to be 312 mg/kg bw.