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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:
supporting study
Study period:
not specified
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was not conducted according to guideline/s and GLP but the report contains sufficient data for interpretation of study results
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1949
Report Date:
1949

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
dermal sensitization study in humans
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
Identified only as L645-139 and s-127035

Method

Type of population:
general
Subjects:
100 men and 100 women
Controls:
no control group
Route of administration:
dermal
Details on study design:
The test material, as a 10% solution in butylcarbitol acetate as placed on the skin of the backs of 100 men and 100 women and allowed to remain for 5 days. Three weeks after removal of the patches, the same material was again applied to the same subjects for 48 hours. The occurrence of a more intense reaction or of a greater incidence of reactions after the second application is indicative that sensitization has occurred and that the test material is a sensitizer.

Results and discussion

Results of examinations:
None of the males or females reacted to either the first or second application of the test material.

Any other information on results incl. tables

These results suggest that the test material is neither a skin sensitizer nor a skin irritant of significance.

Applicant's summary and conclusion

Conclusions:
None of the males or females reacted to either the first or second application of the test material.
Executive summary:

The dermal sensitization potential of the test material was examined in 100 males and 100 females. None of the males or females reacted to either the first or second application of the test material. These results suggest that the test material is neither a skin sensitizer nor a skin irritant of significance.