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Toxicological information

Acute Toxicity: other routes

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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-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
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

Reference
Name:
Unnamed
Type:
Constituent
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 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.