3,6,9,12-tetraoxotridecanol

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1960-62

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

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.

Data source

Reference

Reference 1

Reference Type:

other company data

Title:

Unnamed

Year:

1958

Report date:

1958

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:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-(2-(2-methoxyethoxy)ethoxy)ethanol

EC Number:

203-962-1

EC Name:

2-(2-(2-methoxyethoxy)ethoxy)ethanol

Cas Number:

112-35-6

Molecular formula:

C7H16O4

IUPAC Name:

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

Details on test material:

Sample ref S182735. No further 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: ~2.5kg
- Age at study initiation: 3-5 months.
- Other: albino rabbits used.
- Diet: Rockland rabbit diet

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, 10, 20ml/kg

No. of animals per sex per dose:

2, 4, 2, 1 respectively.

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:

7.1 mg/kg bw

Mortality:

All animals in top two dose groups died but none in lower two dose groups.

Clinical signs:

other: Marked erythema seen. Otherwise no signs in lower two dose groups.

Gross pathology:

Hihg dose animal and one of the 10ml/kg animals showed internal and lung hemorrhage. Livers were congested and kidneys pale and possibly swollen.

Any other information on results incl. tables

Results:

Dose (ml/kg)	Mortality	Day of death	Average weight gain (g)
10	2/2	Both day 4
5	0/4	-	135 (SD=163)
2.5	0/2	-	100 (SD=130)

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 key basic details were reported, an LD50 of 7100mg/kg was obtain. Exposure was under occluded conditions.

Synopsis

LD50=7100mg/kg