2,2'-[ethane-1,2-diylbis(oxy)]bisethyl diacetate

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:

other: Basic data given. Lack of test material details and individual data.

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1984

Report date:

1984

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

lack of test material details and individual data

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

2,2'-[ethane-1,2-diylbis(oxy)]bisethyl diacetate

EC Number:

203-846-0

EC Name:

2,2'-[ethane-1,2-diylbis(oxy)]bisethyl diacetate

Cas Number:

111-21-7

Molecular formula:

C10H18O6

IUPAC Name:

2-[2-(2-acetyloxyethoxy)ethoxy]ethyl acetate

Details on test material:

- Name of test material (as cited in study report): Triethylene glycol diacetate
- Analytical purity: no data

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Breeding Laboratories
- Fasting period before study: 18 h
- Diet: Purina Laboratory Chow, ad libitum
- Water: ad libitum

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 22 mL/kg bw

Doses:

six dose levels from 9.0 - 22.0 mL/kg bw

No. of animals per sex per dose:

6

Control animals:

no

Statistics:

The LD50 was calculated by the method of Lichtfield and Wilcoxon (1949).

Results and discussion

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

13.8 mL/kg bw

Based on:

test mat.

Effect levels 2

Sex:

male

Dose descriptor:

LD50

Effect level:

15 594 mg/kg bw

Based on:

test mat.

Remarks on result:

other: mean dose value as calculated from relative density 1.13 (Esterchem, 2011)

Mortality:

The animals that died usually died within 10-60 min following administration.

Clinical signs:

Prior to death animals showed vasodilation, gasping, cyanosis and prostration.

Gross pathology:

6 rats of the 14.1 mL/kg bw group were necropsied and examined microscopically. 4 of the rats had died 1 h after administration. Examination of the tissue showed that the animals died of shock. The remaining 2 rats survived 12 days and had no gross or microscopic lesions in any organs examined except that the liver showed a slight increase in hepatocytic mitosis.

Other findings:

None of the rats observed in the gross pathology showed any evidence of glycol toxicity. Nephrosis or calcium oxalate crystal deposition in the tubules of the kidney did not occur.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: not classified
DSD: not classified