Registration Dossier

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Human study without test guidelines that is not applicable to GLP study conduct. Sufficient data are available for interpretation of results.
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1957

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Tested according to the method of Shelanski and Shelanski (proceedings of the Scientific Section of the Toilet Goods Association, NO. 19, May, 1953)
GLP compliance:
no
Remarks:
not applicable to human studies

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Dowfax 2A1

Method

Type of population:
general
Ethical approval:
not specified
Subjects:
50 human subjects, 25 males and 25 females.
Clinical history:
No data
Controls:
No data
Route of administration:
dermal
Details on study design:
Dowfax 2A1 as a 15% aqueous solution was tested according to the method of Shelanski and Shelanski (proceedings of the Scientific Section of the T Toilet Goods Association, NO. 19, May, 1953). This test involves the application of the test material 5 times a week for 3 weeks to a group of 50 human subjects, 25 males and 25 females for 24 hours. 2 to 3 weeks after this routine a challenge application is made to each person at the same site.

A response after the initial application is interpreted as indicating the potential of the material to produce primary irritation. An increase in the intensity of the response occurring later in the routine of exposures indicates the ability of the material to cause fatiguing of the skin. A response after the challenge application greater iin intensity than that observed initially indicates the potential ability of the material to produce an allergenic response.

Results and discussion

Results of examinations:
Number of subjects negative throughout: 12
Number of subjects reacting: 38
Number of subjects showing 1+ maximum reactions: 37
Number of subjects showing 2+ maximum reactions:. 1

Any other information on results incl. tables

Morris V. Shelanski, M.D, C,M,, Director of Industrial Toxicology Laboratories.

"Dowfax 2A1- This material is neither a primary irritant nor a sensitizer. It may be considered a mild fatiguing agent. This material is safe to use when in contact with the human skin since it is a milder fatiguing agent than 5% weight by volume solution of ordinary commercial soap. "

Joseph V. Klauder, M.D., Consultant Dermatologist who personally examined the subjects during this test period.

"In the case of material 2 (Dowfax 2A1 ) with two exceptions positive reaction comprised 1+ grade and totalled 102 of the 750 applications. There was no reaction after the initial application, hence, no evidence of primary irritant action. The evidence of fatiguing action was somewhat greater than with material 1 (another material being studied at the same time) but still could be classified as weak. There was no evidence of allergenic action. "

Applicant's summary and conclusion

Conclusions:
Tests upon 50 human subjects have indicated that a 15% aqueous solution of this substance is not a primary skin irritant and skin sensitizer.
Executive summary:

Dowfax 2A1 as a 15% aqueous solution was tested according to the method of Shelanski and Shelanski (proceedings of the Scientific Section of the T Toilet Goods Association, NO. 19, May, 1953). This test involves the application of the test material 5 times a week for 3 weeks to a group of 50 human subjects, 25 males and 25 females for 24 hours. Two to 3 weeks after this routine a challenge application is made to each person at the same site.

Tests upon 50 human subjects have indicated that a 15% aqueous solution of this substance is not a primary irritant, but it caused very slight fatiguing of the skin.

Dowfax 2A1 did not produce evidence of skin sensitization.