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Toxicological information

Skin sensitisation

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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:
comparable to guideline study with acceptable restrictions

Data source

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

Materials and methods

Test guideline
Qualifier:
no guideline available
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 application, the concentration was further reduced to 1% in 50B for the remaining 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
Justification for non-LLNA method:
This study was conducted due to non-REACH regulatory requirements. With the existing data from this study not only being acceptable but of good quality (Klimisch Score 2), this study precludes the need for an additional LLNA study. In addition, a supplementary LLNA study would violate the ECHA objectives with regards to animal welfare.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: R. L. Titus, K1937-5 (Ref.: Bi/38; Bi/809)

In vivo test system

Test animals

Species:
human
Sex:
male/female

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, occlusive
Vehicle:
other: Dowanol 50B
Concentration / amount:
1, 2.5, 5%
Challenge
Route:
epicutaneous, occlusive
Vehicle:
other: Dowanol 50B
Concentration / amount:
1 %
Day(s)/duration:
14 / 24 hours
No. of animals per dose:
25 of each sex
Challenge controls:
vehicle (Dowanol 50B)
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:
1%
No. with + reactions:
5
Total no. in group:
50
Clinical observations:
1 male showed a 2+ reaction, 3 male subjects showed a 3+ reaction, and 1 female subject showed a 3+ reaction
Group:
positive control
Remarks on result:
not measured/tested
Group:
negative control
Remarks on result:
not measured/tested

Any other information on results incl. tables

The material was found to cause a sensitization reaction in 5 of 50 human subjects patch tested by a repeated insult technique.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (skin sensitising) based on GHS criteria