Registration Dossier

Toxicological information

Acute Toxicity: oral

Currently viewing:

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:
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

Reference
Name:
Unnamed
Type:
Constituent
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 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 levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
13.8 mL/kg bw
Based on:
test mat.
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