Reaction mass of 2,2'-(ethylenedioxy)diethanol and 3,6,9,12,15-pentaoxaheptadecane-1,17-diol and 3,6,9,12-tetraoxatetradecane-1,14-d

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: basic information given

Justification for type of information:

Read across is based on the category approach. Please refer to attached category document.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Principles of method if other than guideline:

LD50 calculation

GLP compliance:

not specified

Test type:

standard acute method

Test material

Test material information

Constituent 1

Reference substance name:

2,2'-(ethylenedioxy)diethanol

EC Number:

203-953-2

EC Name:

2,2'-(ethylenedioxy)diethanol

Cas Number:

112-27-6

Molecular formula:

C6H14O4

IUPAC Name:

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

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Administration / exposure

Type of coverage:

other: intact skin of the trunk

Vehicle:

not specified

Details on dermal exposure:

Animals weighing between 2.0 and 3.0 kg are subjected to 24 hours of contact with TEG which is retained under impervious sheeting on the clilpped, intact skin of the trunk. As necessary for larger doses, gauze is wrapped around the trunk over the sample to prevent leakage. Vetrap Bandaging Tape is wrapped over the impervious sheeting and the animal is returned to its cage for the contact period. Doses are varied by adjusting the volume or weight of the test material. Solids are dosed as powders and are moistened with a sufficient amount of water or other suitable vehicle to form a paste. After the contact period, excess fluid is removed to diminish ingestion. Observations for skin reaction are made at one hour, 7 days and 14 days after the contact period. 5 males and 5 females are included on each level used for the LD50 calculation.

Duration of exposure:

24 hours

Doses:

16.0 ml/kg

No. of animals per sex per dose:

5

Control animals:

not specified

Statistics:

no data

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 16 mL/kg bw

Based on:

test mat.

Remarks on result:

other: 1 female animal died.

Mortality:

males: 0/5
females: 1/5

Clinical signs:

other: There were no cutaneous effects observed on any animal during the observation period. The only abnormal signs noted were emaciation (in one female) and abdominal distention (in 2 females)

Gross pathology:

Necropsy of the animal that died revealed gas-filled intestines.

Any other information on results incl. tables

None of 5 male rabbits died from 16.0 ml/kg. One of 5 females died from this dose. There were no cutaneous effects observed on any animal during the observation period. The only abnormal signs noted were emaciation (in one female) and abdominal distention (in 2 females). One female rabbit died at 6 days. Necropsy of the animal that died revealed gas-filled intestines. The afore-mentioned signs, the one death and the necropsy findings could be attributable to a spontaneous intestinal disorder often observed in this species rather than to chemical toxicity. Gross pathologic evaluation of survivors revealed tan lungs (of one female), liquid-filled stomach and intestines (one female) and slight vascularization of the treated skin (one male).

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

LD50 (18000 mg/kg) does not meet criteria for classification

Conclusions:

The LD50 for rabbits exposed to TEG dermally for 24 hours under occlusive conditions is >16 ml/kg (~ >18000 mg/kg).