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EC number: 226-159-8 | CAS number: 5306-85-4
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:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Only limited information regarding the animal environmental conditions is available. Test animals were observed for 7 days post-application, which is a deviation from the OECD guideline.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 957
- Report date:
- 1957
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- Animals were observed for clinical signs and mortality for only 7 days post-application.
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- 1,4:3,6-dianhydro-2,5-di-O-methyl-D-glucitol
- EC Number:
- 226-159-8
- EC Name:
- 1,4:3,6-dianhydro-2,5-di-O-methyl-D-glucitol
- Cas Number:
- 5306-85-4
- Molecular formula:
- C8H14O4
- IUPAC Name:
- 1,4:3,6-dianhydro-2,5-di-O-methyl-D-glucitol
- Test material form:
- other: liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Albino (Holtzman strain)
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 104 – 120 g
- Fasting period before study: 3 - 4 h prior to dosing
- Housing: Animals were housed by groups in metal cages suspended above the droppings.
- Diet: ad libitum
- Water: ad libitum
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 10 and 100% (v/v)
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw - Doses:
- 1.47, 2.15, 3.16, 4.61, 6.81 and 10 mL/kg b.w.
- No. of animals per sex per dose:
- 5 (males)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 7 days
- Frequency of observations and weighing: Animals were observed closely for gross signs of systemic toxicity at frequent intervals during the day of administration of the test material and daily thereafter for a period of seven days.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- Statistical analysis of the mortality data done by the moving average method (Horn, 1956).
Results and discussion
Effect levels
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 5.63 mL/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: All animals dosed with 6.81 and 10.0 mL/kg bw of the test material died within 2 days and 4 h post-application.
- Mortality:
- Animals died 1 hour (1/5), 4 hours (3/5) and 48 hours (1/5) post-administration with 6.81 mL/kg bw of the test material. Mortality of animals treated with the highest dose level of 10 mL/kg bw occurred 1 hour (3/5) and 4 hours (2/5) post-administration of the test material.
- Clinical signs:
- other: Within 5 – 10 min following oral administration of the test material the animals at each dose level tested appeared depressed and showed lacrimation, labored respiration, tachycardia and ataxia. During the reminder of the day the animals at the lowest dos
- Gross pathology:
- Gross pathology performed upon the animals that died showed hyperemic and inflated lungs, slight irritation of the small intestine, and congested kidneys and adrenals. In addition, the blood appeared to have a thin consistency and did not clot readily. A gross autopsy of the surviving animals revealed no gross pathological findings.
Any other information on results incl. tables
Table 1: Mortality
Dose [mL/kg bw] |
Concentration of solution [%] |
Time of Death |
||||||||||
Hours |
Days |
|||||||||||
Immediate |
1 |
2 |
4 |
24 |
2 |
3 |
4 |
5 |
6 |
7 |
||
1.47 |
10 |
0/5 |
0/5 |
0/5 |
0/5 |
0/5 |
0/5 |
0/5 |
0/5 |
0/5 |
0/5 |
0/5 |
2.15 |
10 |
0/5 |
0/5 |
0/5 |
0/5 |
0/5 |
0/5 |
0/5 |
0/5 |
0/5 |
0/5 |
0/5 |
3.16 |
100 |
0/5 |
0/5 |
0/5 |
0/5 |
0/5 |
0/5 |
0/5 |
0/5 |
0/5 |
0/5 |
0/5 |
4.04 |
100 |
0/5 |
0/5 |
0/5 |
0/5 |
0/5 |
0/5 |
0/5 |
0/5 |
0/5 |
0/5 |
0/5 |
6.81 |
100 |
0/5 |
1/5 |
1/5 |
4/5 |
4/5 |
5/5 |
- |
- |
- |
- |
- |
10.0 |
100 |
0/5 |
3/5 |
3/5 |
5/5 |
- |
- |
- |
- |
- |
- |
- |
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
- Conclusions:
- In this acute oral toxicity study a LD50 value of 5.63 mL/kg (corresponding to 6565 mg/kg bw based on a density of 1.166 g/cm³) bw was calculated in male rats.
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