Benzene, 1,1'-oxybis-, tetrapropylene derivs., sulfonated, sodium salts

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

No data

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study was not conducted according to guideline/s and GLP, but the report contains sufficient data for interpretation of study results.

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

A single application of 2000 mg/kg of neat DOWFAX 2A1 was applied to the clipped trunks of two male New Zealand White rabbits under an impervious, occlusive bandage. Following exposure, observations and body weights were recorded over a 2-week period.

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Benzene, 1,1'-oxybis-, tetrapropylene derivs., sulfonated, sodium salts

EC Number:

601-601-6

Cas Number:

119345-04-9

Molecular formula:

C24H32O7S2Na2

IUPAC Name:

Benzene, 1,1'-oxybis-, tetrapropylene derivs., sulfonated, sodium salts

Details on test material:

Test material: Dowfax 2A1
Source: Specialty Chemicals, The Dow Chemical Company
Properties: Amber liquid
pH= 7.0

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male

Details on test animals or test system and environmental conditions:

No additional data

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

In the acute dermal absorption test, animals were prepared 24 hours prior to dosing by clipping the trunk. A single application of 2000 mg/kg of neat DOWFAX 2A1 was applied to the clipped trunks of two male New Zealand White rabbits under an impervious, occlusive bandage. Residual test material was washed off when the bandage was removed 24 hours after application, and the animals were collared until dry to prevent grooming of the application site.

Duration of exposure:

24 hours

Doses:

2000 mg/kg

No. of animals per sex per dose:

2 male rabbits/dose

Control animals:

no

Details on study design:

In the acute dermal absorption test, animals were prepared 24 hours prior to dosing by clipping the trunk. A single application of 2000 mg/kg of neat Dowfax 2A1 was applied to the clipped trunks of two male New Zealand White rabbits under an impervious, occlusive bandage. Residual test material was washed off when the bandage was removed 24 hours after application, and the animals were collared until dry to prevent grooming of the application site. Following exposure, observations and body weights were recorded over a 2-week period.

Statistics:

None

Results and discussion

Preliminary study:

Not applicable

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No mortality

Clinical signs:

other: Erythema, edema and burns were observed, at the application site, immediately after removing the wrap. Due to the fact that, in the previous skin irritation test, five consecutive daily applications of this test material to an intact site, and three to a

Gross pathology:

No data

Other findings:

None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

Criteria used for interpretation of results: other: EU GHS

Conclusions:

The estimated acute dermal LD50 for male New Zealand White rabbits was greater than 2000 mg/kg.

Executive summary:

A single application of 2000 mg/kg of neat DOWFAX 2A1 was applied to the clipped trunks of two male New Zealand White rabbits under an impervious, occlusive bandage. Erythema, edema and burns were observed, at the application site, immediately after removing the wrap. Due to the fact that, in the previous skin irritation test, five consecutive daily applications of this test material to an intact site, and three to a slightly abraded site (minor incision through the stratum corneum of insuffiaent depth to produce bleeding), caused only very slight irritation to the skin, it is felt that these burns may be a result of the procedure used in preparing the animals for testing. These observations were noted through test day four in one animal, and test day eight in the other. By test day eight, both animals were observed with scaling which persisted through the end of the study. Administration of DOWFAX 2A1 at 2000 mg/kg had no apparent effect on body weight during the two-week observation period. The estimated acute dermal LD50 for male New Zealand White rabbits was greater than 2000 mg/kg.