Registration Dossier

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: secondary literature

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
1980

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Principles of method if other than guideline:
53 volunteers, 15 applications of a formulation, said to contain less than 25 % tributyl phosphate, were made on alternate days. No volunteer gave local reactions 24 hours after the final patch, therefore no evidence of sensitization.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Tributyl phosphate
EC Number:
204-800-2
EC Name:
Tributyl phosphate
Cas Number:
126-73-8
Molecular formula:
C12H27O4P
IUPAC Name:
tributyl phosphate
Details on test material:
no data

Method

Type of population:
other: volunteers
Controls:
no data
Route of administration:
dermal

Results and discussion

Results of examinations:
No volunteer gave local reactions 24 hours after the final patch, therefore no evidence of sensitization.

Any other information on results incl. tables

no further data

Applicant's summary and conclusion

Executive summary:

53 volunteers, 15 applications of a formulation, said to contain less than 25% tributyl phoshate , were made on alternate days. No volunteer gave local reactions 24 hours after the final patch, therefore no evidence of sensitization.