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Diss Factsheets

Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1993
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-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
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 3B2 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 bandages were removed 24 hours after application, and the animals were collared until dry to prevent grooming of the application site. Observations and body weights were recorded over a 2-week period.
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction mass of Disodium decyl(sulphonatophenoxy)benzenesulphonate and Disodium oxybis[decylbenzenesulphonate]
EC Number:
915-640-4
Molecular formula:
C22 H30 O7 S2 . 2 Na
IUPAC Name:
Reaction mass of Disodium decyl(sulphonatophenoxy)benzenesulphonate and Disodium oxybis[decylbenzenesulphonate]
Details on test material:
Dowfax 3B2
Appearance: gold liquid
pH: 6.5
Reference: APE911216
Source: Specialty Chemicals, The Dow Chemical Company
Production Specification: 45-47% active ingredient

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male
Details on test animals or test system and environmental conditions:
In the acute dermal absorption test, animals were prepared 24 hours prior to dosing by clipping the trunk.

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
A single application of 2000 mg/kg of neat Dowfax 3B2 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 bandages were removed 24 hours after application, and the animals were collared until dry to prevent grooming of the application site.
Duration of exposure:
24 h
Doses:
2000 mg/kg
No. of animals per sex per dose:
2 male rabbits
Control animals:
no
Details on study design:
A single application of 2000 mg/kg of neat Dowfax 3B2 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 bandages were removed 24 hours after application, and the animals were collared until dry to prevent grooming of the application site. Observations and body weights were recorded over a 2-week period.
Statistics:
None

Results and discussion

Preliminary study:
No data
Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
None
Clinical signs:
other: Erythema, edema and bums were observed, at the application site, immediately after removing the wrap. These observations were observed through test day four. By test day eight, both animals were observed with scaling, which persisted through the end of th
Gross pathology:
None
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 sample of Dowfax 3B2 solution surfactant was submitted by Specialty Chemicals, The Dow Chemical Company, Midland. MI for evaluation of acute oral and dermal toxicity and skin and eye irritation. This compound is a potential ingredient in cleaning solutions.

A single application of 2000 mg/kg of neat Dowfax 3B2 was applied to the clipped tnmks 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. These observations were observed through test day four. By test day eight, both animals were observed with scaling, which persisted through the end of the study. Both animals survived the test period at the 2000 mg/kg dose level. The estimated acute dermal LD50 for male New Zealand White rabbits was greater than 2000 mg/kg.