Registration Dossier

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Study period:
1966
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well described and well performed study with minor deviations: No data on signs and symptoms of toxicity
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1966

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Principles of method if other than guideline:
Maximization test for identification of contact allergens by human assay (Kligman, 1966)

GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Turpentine


Method

Type of population:
other: prisoners
Subjects:
- Number of subjects exposed: 25
- Sex: Male
- Age: 18-50 years
- Race: Negroes (90% of experimental subjects)
Controls:
No data
Route of administration:
dermal
Details on study design:
TYPE OF TEST(S) USED: Patch test (epicutaneous test)

ADMINISTRATION
- Type of application: occlusive
- Description of patch: Patch material is a nonwoven, highly absorbent, cloth, prepared by Curity under the trade name of Webril
- Vehicle / solvent: Petrolatum
- Concentrations: 50% (induction concentration) and 20% (Challenge concentration)

EXAMINATIONS
- Grading/Scoring system: Maximization grading:

Sensitization rate 0-2/25- Grade1- Weak sensitizer
Sensitization rate 3-7/25- Grade 2- Mild sensitizer
Sensitization rate 8-13/25- Grade 3- Moderate sensitizer
Sensitization rate 14-20/25- Grade 4- Strong sensitizer
Sensitization rate 21-25/25- Grade 5- Extreme sensitizer

Results and discussion

Results of examinations:
NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 18
- Number of subjects with negative reactions: 7

Any other information on results incl. tables

None

Applicant's summary and conclusion

Conclusions:
Under the test conditions, turpentine oil was considered to be a strong sensitizer (Grade 4) in humans.
Executive summary:

In a study performed to assess the contact sensitization potential of turpentine oil by maximization test in humans, panels of 25 healthy adult male Negroes were induced with five exposures of dermal dose of 50% of turpentine oil in petrolatum for 48 hours using an occlusive patch followed by challenge dose of 20%. The challenge reaction was read immediately after removal of the 48 hour patch and again in another two days. An evident erythema was considered a minimum positive response. Sensitization potential was rated according to grading system as described in report,

 

A total of 18 out of 25 subjects showed positive reaction to sensitization during the study.

 

Under the test conditions, turpentine oil was considered to be a strong sensitizer (Grade 4) in humans.