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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation
Remarks:
in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: similar to Guideline study with adequate documentation

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1954

Materials and methods

Principles of method if other than guideline:
Lintine discs having a diameter of 1 1/4 inches were saturated with methylene dianiline dissolved in Dowanol 50B. The
patches were applied every other day for 15 applications to the skin of the fifty subjects. Results were graded and recorded
upon removal of the patches. Twenty-four hours after removal of the patches, the sites were examined for delayed reactions. The material was originally patched as a 5% solution in Dowanol 50B. After the second application, the concentration was reduced to 2 1/2%. Following the fourth appllcation, the concentration was further reduced to 1% in 50B for the remalning number of applications.
Following a two week recuperation period after the removal of the fifteenth application, the methylene dianiline as a 1% solution in Dowanol 50B was re-applied for twenty-four hours. Results were graded and recorded upon removal of the patches.
Twenty-four hours after removal, the sites were examined for delayed reactions.
GLP compliance:
no
Remarks:
prior to GLP
Type of study:
other: Human Repeated Insult Patch test

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

Species:
human
Sex:
male/female

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: Dowanol 50B
Concentration / amount:
1, 2.5 and 5%
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: Dowanol 50B
Concentration / amount:
1, 2.5 and 5%
No. of animals per dose:
25 of each sex
Challenge controls:
vehicle (Dowanol 50B)

Results and discussion

In vivo (non-LLNA)

Results
Reading:
1st reading
Hours after challenge:
0
Group:
test group
Dose level:
1%
No. with + reactions:
4
Total no. in group:
50
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 0.0. Group: test group. Dose level: 1%. No with. + reactions: 4.0. Total no. in groups: 50.0.

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information
Conclusions:
The material was found to cause a sensitization reaction in 5 of 50 human subjects patch tested by a repeated insult technique.