Registration Dossier

Administrative data

acute toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given. Lack of test material details and no individual data.

Data source

Reference Type:
The single dose toxicity of some glycols and derivatives
Smyth, H. et al.
Bibliographic source:
Journal of Industrial Hygiene and Toxicology, 23:259-268

Materials and methods

Principles of method if other than guideline:
Single oral administration by stomach tube in male rats.
GLP compliance:
Test type:
standard acute method

Test material

Constituent 1
Chemical structure
Reference substance name:
Ethylene di(acetate)
EC Number:
EC Name:
Ethylene di(acetate)
Cas Number:
Molecular formula:
ethane-1,2-diyl diacetate
Details on test material:
- Name of test material (as cited in study report): Ethylene glycol diacetate
- Analytical purity: no data

Test animals

other: albino Wistar
Details on test animals or test system and environmental conditions:
- Weight at study initiation: 90 - 120 g
- Diet: Purina chows, supplemented by fresh vegetables
- Water: ad libitum

Administration / exposure

Route of administration:
oral: gavage
Details on oral exposure:
- Concentration in vehicle: maximal concentration 500 mg/mL

DOSAGE PREPARATION (if unusual): The test material was insufficiently soluble to be fed in solution and was handled as temporary disperios in 1% aqueous sodium sulfate of heptadecanol (trademarked "Tergitol" penetrant 7).

MAXIMUM DOSE VOLUME APPLIED: Individual dose levels were not reported for any of the substances tested including the test substance considered herein. According to the authors, the highest dose level which could safely be hold at one time by the animal was just over 10% of the animal’s bodyweight, corresponding to approx. 50 g/kg bw, when a substance was administered as a 50% solution. This is equivalent to a dose volume of 100 mL/kg bw.
Furthermore, it was reported that in most cases 10 animals were dosed to determine the toxicity of a particular dosage and enough dosages were given to include those at which no mortality occurred and those at which all tested animals died.
The test substance was administered as a 50% dispersion in 1% aqueous sodium sulfate of heptadecanol (trademarked "Tergitol" penetrant 7) and based on the information above and the resulting LD50 value, it appears unlikely that the test substance could have been administered at a dose volume > 100 mL/kg bw.
It is therefore assumed that the maximum dose volume applied was 100 mL/kg bw corresponding to a maximum dose level of 50000 mg/kg bw.

Not specified (presumably up to 50000 mg/kg bw)
No. of animals per sex per dose:
ca. 10
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs
The data were calculated by the method of probits, described by Bliss C.I. (1935. The calculation of the dosage-mortality curve. Ann. Appl. Biol. 22:134-167).

Results and discussion

Effect levels
Dose descriptor:
Effect level:
6 860 mg/kg bw
Based on:
test mat.
95% CL:
6 640 - 7 080
Remarks on result:
other: slope: 30.33
Mortality data were summarised for all substances tested. Therefore, no substance specific data were reported.
According to the authors, most deaths occurred within the first 48 h post-dose, but all deaths within 14 days post-administration were taken into account for calculation of LD50 values.
Clinical signs:
The test substance was tested along with other glycol esters. For this group, (near) fatal doses caused no narcosis but various degrees of sluggish depressed function.
Gross pathology:
Gross pathology findings were summarised for all substances tested. According to the authors, all doses caused some degree of irritation of the digestive tract. The primary target organ was the kidney; blood in urine and free blood beneath the capsule were seen at the highest dosages. The liver was less affected, but orange or reddish bile was often observed. Glycol esters were reported to produce livers of bright eosin colour.

Applicant's summary and conclusion

Interpretation of results:
not classified
Migrated information Criteria used for interpretation of results: EU
CLP: not classified
DSD: not classified