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Toxicological information

Sensitisation data (human)

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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:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Principles of method if other than guideline:
Repeated Insult Patch Test (modified Shelanski, 4 x 4 method).
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
SH-82-007, N-cyclohexyl-2-benzothiazole sulphenamine, white powder

Method

Type of population:
general
Subjects:
51 male and female volunteers.
Route of administration:
dermal
Details on study design:
Induction: Weeks #1, #2, and #3. A series of 12 applications, each of 24 hours' duration was scheduled to be carried out during weeks #1, #2, and #3.
Rest period: Weeks #4 and #5
Challenge: Week #6: A series of 4 applications on virgin sites was scheduled to be carried out during the challenge week.

Results and discussion

Results of examinations:
5/51 volunteers were sensitized.

Any other information on results incl. tables

Induction phase:

The test material produced irritation in eight (8/51) individuals during the induction phase

In 5 of these individuals, minimal erythema was observed sporadically and was not considered of any significance.

In 3 indivuduals intense erythema was present when the thenth application was removed. In panelist no. 37 and 39, the intense irritation was not discovered until several days after the twelfth application had been removed.

Challenge phase:

The test material produced in seven (7/51) individuals during the course of these applications. A minimal solitary irritation was observed in two (2) individuals. These response were not considered of any significance. In five (5/51) individuals, including the three (3/51) discussed during the induction phase, Grade 3 response were discovered. These responses were typical of an allergic contact dermatities, indicating that the test material had successfully sensitized these five (5/51) individuals.

during the course of this evalaution, not only were the sites occupied by this material involved but the effect was manifested as a"spill-over" phenomenon on adjacent sites occupied by innocuous materials.

Applicant's summary and conclusion

Conclusions:
5/51 volunteers were sensitized.
Executive summary:

In a repeated insult patch test with 51 volunteers using a 70 % test substance preparation in petrolatum, CBS acted as a sensitizer in 5/51 individuals. These five individuals, showed Grade 3 responses (erythema). The authors concluded, that these responses were typical of an allergic contact dermatities, indicating that the test material had successfully sensitized these five (5/51) individuals. (Monsanto company 1982).