Registration Dossier

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report Date:
2001

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:
human repeat insult patch test (HRIPT)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Eastman SAIB-100, Industrial Grade
GMNP0119702
PM 01197-00
Lot#0023134

Glass bottle containing a transparent yellow gel

20% w/w in Acetone

Method

Type of population:
general
Ethical approval:
confirmed, but no further information available
Subjects:
Two hundred fifty-five ( 49 males, 206 females) subjects were screened for the study. Two
hundred forty-one ( 44 males, 197 females) subjects, ages 18 and older, signed the
informed consent and were enrolled onto the study.
Thirty-eight subjects, who were enrolled, failed to complete the study. The subject number
and reason for non-completion are listed in Appendix IV.
Two hundred three subjects (40 males, 163 females) completed all phases of the study.

Study Initiated: April 9, 2001
Date Completed: June 29, 2001
Details on study design:
The objective of this study was to evaluate six individual test articles for the induction of contact sensitization by repetitive applications to the skin of human volunteers and to report any irritation observed with the test articles. Two hundred three subjects completed all phases of the study.

The test articles listed below were tested simultaneously in this study employing the referenced concentrations. The test articles were received by Hill Top Research on February 16, 2001.

A EAN 063039, PM 03758 "TOTM" Plasticizer of plastics
B EAN 002800, PM 01315 "TXIB" Plasticizer of plastics
C EAN 908266, PM 01197, SAIB-100, Industrial Grade
D EAN 975778, PM 23094 Fiber lubricant
E EAN 907040, PM 04595 "DOTP" plasticizer manufacturing of plastics
F EAN 900124, PM 00080 "DEP" plasticizer


Under the conditions of the study, HTR Code A (EAN 063039, PM 03758 "TOTM" Plasticizer), HTR Code B (EAN 002800, PM 01315 "TXIB" Plasticizer), HTR Code C (EAN 908266, PM 01197, SAIB-100, Industrial Grade), HTR CodeD (EAN 975778, PM 23094), HTR Code E (EAN 907040, PM 04595 "DOTP" plasticizer) and HTR Code F · (EAN 900124, PM 00080 "DEP" plasticizer) \Vere found to be non-irritating and did not elicit evidence of sensitization.

Results and discussion

Results of examinations:
There were nine adverse events which occurred during the course of this study. One of which was definitely related, one possibly related and the remainder unrelated to the test articles. These are listed in Appendix V. One of the reported adverse events was a severe adverse event (SAE). Subject No. 183 reported enlarged lymph nodes in the cervical area on April 13, 2001. The subject was discontinued from the study, went under a physician's
care and was initially diagnosed with breast cancer. Subsequent tests were inconclusive for cancer or any other diagnosis. The event was ongoing at the end of the study.

Under the conditions of the study, HTR Code A (EAN 063039, PM 03758 "TOTM" Plasticizer), HTR Code B (EAN 002800, PM 01315 "TXIB" Plasticizer), HTR Code C (EAN 908266, PM 01197, SAIB-100, Industrial Grade), HTR CodeD (EAN 975778, PM 23094), HTR Code E (EAN 907040, PM 04595 "DOTP" plasticizer) and HTR Code F · (EAN 900124, PM 00080 "DEP" plasticizer) \Vere found to be non-irritating and did not elicit evidence of sensitization.

Any other information on results incl. tables

HTR Code C (EAN 908266, PM 01197, SAIB-1 00, Industrial Grade): Responses during induction consisted of isolated instances of slight erythema and 2 occurrences of mild erythema. Responses during challenge consisted of 3 instances of slight erythema at 48 hours, all of which resolved by 96 hours, and a single instance of slight erythema first appearing at the 96-hour evaluation (Subject No. 1 02). Under the conditions of the study, EAN 908266, PM 01197, SAIB-100, Industrial Grade was found to be non-irritating and did not elicit evidence of sensitization.

Applicant's summary and conclusion

Conclusions:
Under the conditions of the study, SAIB was found to be non-irritating and did not elicit evidence of sensitization.
Executive summary:

The objective of this study was to evaluate six individual test articles for the induction of contact sensitization by repetitive applications to the skin of human volunteers and to report any irritation observed with the test articles. One of the test articles was SAIB, which was applied to the skin of volunteers as a 20% solution in acetone. Data indicate that SAIB was found to be non-irritating and did not elicit evidence of sensitization.