Registration Dossier

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
Not specified
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study not conducted in compliance with GLP, however, data included in SIDS OECD works as supporting information.
Cross-reference
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
other: SIDS DOSSIER DATA
Title:
Unnamed
Year:
1953
Report Date:
1953

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:
25 males and 25 females volunteers were used in this study. 13 of each sex were African Americans and 12 of each sex were Caucasians selected for considerable suntan to facilitate the assessment of depigmentation potential. The test material was applied to identical spots on the backs of the volunteers for 24-hours every other day for 15 applications. Two weeks after the induction period the sites were challenged with the test material for 24-hours. Reactions were evaluated when the patches were removed.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid: viscous
Details on test material:
Referenced only as BFGoodrich Material No. 2 (Stalite) , purity: Unknown, although detailed as CAS 68921-45-9 in the relevant section of the OECD SIDS report.

Method

Type of population:
general
Ethical approval:
not specified
Subjects:
25 males and 25 females volunteers were used in this study. 13 of each sex were African Americans and 12 of each sex were Caucasians selected for considerable suntan to facilitate the assessment of depigmentation potential.
Clinical history:
Not specified
Controls:
Not specified
Route of administration:
dermal
Details on study design:
The test material was applied to identical spots on the backs of the volunteers for 24-hours every other day for 15 applications. Two weeks after the induction period the sites were challenged with the test material for 24-hours. Reactions were evaluated when the patches were removed.

Results and discussion

Results of examinations:
A minimal transitory reaction was noted in 3 males and 4 females; these were considered insignificant and minimal. No depigmentation was noted.
The material was considered not to be a primary irritant, fatiguing agent or sensitizer

Applicant's summary and conclusion

Conclusions:
A minimal transitory reaction was noted in 3 males and 4 females; these were considered insignificant and minimal. No depigmentation was noted.
The material was considered not to be a primary irritant, fatiguing agent or sensitizer
Executive summary:

A minimal transitory reaction was noted in 3 males and 4 females; these were considered insignificant and minimal. No depigmentation was noted. The material was considered not to be a primary irritant, fatiguing agent or sensitizer.