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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:
weight of evidence
Study period:
1959
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Only short abstract available
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1959
Report Date:
1959

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Principles of method if other than guideline:
Human patch test
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Only trade name given
- Analytical purity: no data
- Lot/batch No.: 157

Method

Type of population:
not specified
Subjects:
- Number of subjects exposed: 50
- Sex: no data
- Age: no data
- Race: no data
- Demographic information: no data
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: absorbent cotton twill (2.5x5 cm) saturated with test material, sealed with elastoplast coverlet (5x7.5 cm)
- Concentrations: undiluted
- Volume applied: no data
- Testing/scoring schedule: Initial application for 3 days, challenging application for 3 days 7 days after removal of initial patch

EXAMINATIONS
- Grading/Scoring system: no data

Results and discussion

Results of examinations:
NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 0/50
- Number of subjects with negative reactions: 50/50
- Number of subjects with equivocal reactions: 0/50
- Number of subjects with irritating reactions: 0/50

Applicant's summary and conclusion

Conclusions:
At the end of the 72 h exposure period in the initial application there were no reactions on the skin of any of the subjects. This shows that the chemical is not a primary skin irritant.
At the end of the 72 h exposure period in the challenging application there were no reactions on the skin of any of the subjects. There were no delayed reactions after the first and second series of patches. This indicates that the chemical is not a sensitizer.