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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
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

Principles of method if other than guideline:
Repeated Insult Patch Test (modified Shelanski, 4 x 4 method)
GLP compliance:
no
Type of study:
patch test
Justification for non-LLNA method:
Study was conducted in the year 1982 on human volunteers.

Test material

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

In vivo test system

Test animals

Species:
human
Sex:
male/female

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
70% in petrolatum
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
70% in petrolatum
No. of animals per dose:
51 human volunteers
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.
Positive control substance(s):
no

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
70%
No. with + reactions:
5
Total no. in group:
51
Clinical observations:
In five (5/51) individuals Grade 3 response were discovered (clear distinguished from individuals with irritations); these responses were typical of an allergic contact dermatitis, indicating that the test material had successfully sensitized these five
Remarks on result:
other: see Remark
Remarks:
Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 70%. No with. + reactions: 5.0. Total no. in groups: 51.0. Clinical observations: In five (5/51) individuals Grade 3 response were discovered (clear distinguished from individuals with irritations); these responses were typical of an allergic contact dermatities, indicating that the test material had successfully sensitized these five .
Group:
negative control
Remarks on result:
other: Human patch test - no negative control group was included
Group:
positive control
Remarks on result:
other: Human patch test - no positive control group was included

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

Interpretation of results:
Category 1 (skin sensitising) based on GHS criteria
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 dermatitis, indicating that the test material had successfully sensitized these five (5/51) individuals. (Monsanto company 1982).