Reaction mass of 3,6,9-trioxaundecane-1,11-diol and 2,2'-oxydiethanol and 2,2'-(ethylenedioxy)diethanol and 3,6,9,12-tetraoxatetrade

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

Study period:

1974-1975

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: non-GLP, non-guideline

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:

1979

Report date:

1979

Materials and methods

Principles of method if other than guideline:

LD50 calculation

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

2,2'-oxydiethanol

EC Number:

203-872-2

EC Name:

2,2'-oxydiethanol

Cas Number:

111-46-6

Molecular formula:

C4H10O3

IUPAC Name:

2,2'-oxydiethanol

Test material form:

other: liquid

Details on test material:

- Name of test material: diethylene glycol
- Physical state: liquid
- Lot/batch No.: 37-519

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 3-5 months
- Diet (e.g. ad libitum): ad libitum, except during period of manipulation or confinement
- Water (e.g. ad libitum): ad libitum, except during period of manipulation or confinement

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

Rabbits are immobilized furing the 24 hour contact period with the compound retained under impervious sheeting on the clipped intact skin of the trunk. Thereafter, excess fluid is removed to prevent ingestion. Maximum dose that can be retained is 16 ml/kg.

Duration of exposure:

24 hours

Doses:

5, 10, 20 ml/kg

No. of animals per sex per dose:

4 males/dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

LD50s are calculated by the moving average method based on a 14 day observation period

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

11.2 mL/kg bw

Based on:

test mat.

95% CL:

ca. 5.28 - ca. 23.9

Mortality:

At 20 ml/kg, 3 of 4 rabbits died, all on day 5. At 10 ml/kg, 2 of 4 rabbits died on days 5 and 7. No deaths occurred at 5 ml/kg.

Clinical signs:

other: No clinical signs were observed. No skin irritation was observed.

Gross pathology:

In victims, lungs and livers were kard and kidneys were pale. In survivors, kidneys were pale and mottled.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

LD50 (11.2 ml/kg) does not meet criteria for classification

Conclusions:

Slightly toxic following acute covered dermal application.

Executive summary:

The LD50 was 11.2 ml/kg (about 12500 mg/kg based on a density of 1.118 at 20 degrees C) for rabbits exposed to diethylene glycol for 24 hours under occlusive conditions.