Registration Dossier

Toxicological information

Skin sensitisation

Currently viewing:

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:
1983
Report Date:
1983

Materials and methods

Principles of method if other than guideline:
Repeated Insult Patch test (modified Shelanski (4 x 4 method))
GLP compliance:
not specified
Type of study:
patch test
Justification for non-LLNA method:
The study was reported 1983. At this time an OECD guideline for a LLNA was not available.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
purity: 97.4 %

In vivo test system

Test animals

Species:
human
Sex:
male/female

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, semiocclusive
Vehicle:
petrolatum
Concentration / amount:
200 mg of the test material tested as a 60 % preparation in petrolatum
Challenge
Route:
epicutaneous, semiocclusive
Vehicle:
petrolatum
Concentration / amount:
200 mg of the test material tested as a 60 % preparation in petrolatum
No. of animals per dose:
54 volunteers
Details on study design:
The potential for TBBS to cause primary skin irritation and/or sensitization was assessed in 54 volunteer human subjects. This chemical was tested as a 60 % preparation in petrolatum.
Positive control substance(s):
no

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
200 mg
No. with + reactions:
15
Total no. in group:
54
Clinical observations:
mild to intense inflammatory changes
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 200 mg. No with. + reactions: 15.0. Total no. in groups: 54.0. Clinical observations: mild to intense inflammatory changes.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
200 mg
No. with + reactions:
13
Total no. in group:
54
Clinical observations:
mild to intense inflammatory changes
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 200 mg. No with. + reactions: 13.0. Total no. in groups: 54.0. Clinical observations: mild to intense inflammatory changes.
Key result
Group:
negative control
Remarks on result:
other: Human patch test - no negative control group was included
Key result
Group:
positive control
Remarks on result:
other: Human patch test - no positive control group was included

Any other information on results incl. tables

Forty-five subjects completed the study. During the induction period, eleven subjects demonstrated intense irritation consisting of erythema and induration. These responses were considered indicative of an allergic reaction. Due to the severity of reaction during the induction period, these eleven subjects were not tested during the portion of the induction phase which followed their response. Following the single 24 hour challenge application, six subjects demonstrated slight to moderate erythema. Twenty-four hours after removal of the test material, mild to intense inflammatory changes were observed in 15 individuals. At 48 hours after removal, responses were still noted in 13 subjects. These responses were considered characteristic for allergic contact dermatitis.

In conclusion, the test substance, tested as a 60 % preparation in petrolatum, produced sensitization in 13/54 subjects who completed the study. No evidence of primary irritation was observed.This chemical was considered to be a strong skin sensitizer.

Applicant's summary and conclusion

Interpretation of results:
Category 1A (indication of significant skin sensitising potential) based on GHS criteria
Conclusions:
The test substance, tested as a 60 % preparation in petrolatum, produced sensitization in 13/54 subjects who completed the study. No evidence of primary irritation was observed.This chemical was considered to be a strong skin sensitizer.
Executive summary:

Forty-five subjects completed the study. During the induction period, eleven subjects demonstrated intense irritation consisting of erythema and induration. These responses were considered indicative of an allergic reaction. Due to the severity of reaction during the induction period, these eleven subjects were not tested during the portion of the induction phase which followed their response. Following the single 24 hour challenge application, six subjects demonstrated slight to moderate erythema. Twenty-four hours after removal of the test material, mild to intense inflammatory changes were observed in 15 individuals. At 48 hours after removal, responses were still noted in 13 subjects. These responses were considered characteristic for allergic contact dermatitis.

In conclusion, the test substance, tested as a 60 % preparation in petrolatum, produced sensitization in 13/54 subjects who completed the study. No evidence of primary irritation was observed.This chemical was considered to be a strong skin sensitizer.