Ethanol, 2-ethoxy-, manufacture of, by-products from

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Study period:

1960-62

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Acceptable, study containing basic data which suggests that basic scientific principles have been met. This is sufficient to judge the results reliable as a contribution to the understanding of the toxicity of this substance. Rationale for using a read across substance is included in summary record for this end point.

Data source

Reference

Reference 1

Reference Type:

other company data

Title:

Unnamed

Year:

1960

Report date:

1960

Reference 2

Reference Type:

publication

Title:

Range finding toxicity data: List VI

Author:

Smyth HF, Carpenter CP, Weil CS, Pozzani UC, Striegel BS

Year:

1962

Bibliographic source:

Am Ind Hyg Ass J, 23, 95

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Study pre-dates guidelines. Similar to one day cuff method of Draize (J Pharmac Exp Therap, 82, 377, 1944)

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-(2-(2-butoxyethoxy)ethoxy)ethanol

EC Number:

205-592-6

EC Name:

2-(2-(2-butoxyethoxy)ethoxy)ethanol

Cas Number:

143-22-6

Molecular formula:

C10H22O4

IUPAC Name:

2-[2-(2-butoxyethoxy)ethoxy]ethanol

Details on test material:

no data.

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2.5-3.5kg
- Age at study initiation: 3-5 months.
- Other: albino rabbits used.

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: Fur removed from entire trunk area by clipping
- % coverage:
- Type of wrap if used: impervious plastic film (VINYLITE)

OTHER
- Animals immobilised during 24 hour exposure period.

Duration of exposure:

24 hours

Doses:

2.5, 5.0 and 10ml/kg

No. of animals per sex per dose:

4

Control animals:

other: no but a large number of other substances also tested which acted as reference materials.

Details on study design:

- Duration of observation period following administration: 14 days after wrap removed following 24 hour exposure.

Statistics:

The moving average method was used to calculate the LD50

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

3 540 mg/kg bw

95% CL:

> 1 050 - < 11 800

Mortality:

Three out of four rabbits treated with 10 ml/kg died within 3 days. Two out of four rabbits treated with 5 ml/kg or 2.5 ml/kg, and one treated with 1.25 ml/kg died by day 9.

Body weight:

The surviving animal in the 10ml/kg group lost 110 g of weight over the 14-day recovery period.

Gross pathology:

Findings upon autopsy were cherry red and hemorrhaged lungs, dark livers mottled with prominent acini, and pale and mottled kidneys.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Executive summary:

In an acute dermal toxicity in rabbits in which only basic details were reported, an LD50 of 3540mg/kg was obtain. Exposure was under occluded conditions. Information available suggests the dose response curve is unusually shallow.

Synopsis

LD50=3540mg/kg