Formaldehyde, oligomeric reaction products with aniline

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

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

Type of sensitisation studied:

skin

Study type:

study with volunteers

Principles of method if other than guideline:

Lintine discs having a diameter of 1.25 inches were saturated with methylene dianiline dissolved in Dowanol 50B. The patches were applied every other day for 15 applications to the skin of fifty subjects. Results were graded and recorded upon removal of the patches. Twenty-four hours after removal, the sites were examined for delayed reactions. The material was originally applied as a 5% solution in Dowanol 50B. After the second application, the concentration was reduced to 2.5%. 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

Test material

Test material information

Constituent 1

Reference substance name:

methylene dianiline

IUPAC Name:

methylene dianiline

Constituent 2

Reference substance name:

4,4'-methylenedianiline

EC Number:

202-974-4

EC Name:

4,4'-methylenedianiline

Cas Number:

101-77-9

Molecular formula:

C13H14N2

IUPAC Name:

4,4'-methylenedianiline

Method

Ethical approval:

not specified

Subjects:

25 subjects of each sex

Route of administration:

dermal

Details on study design:

Route of induction and challenge exposure - epicutaneous, occlusive.
Lintine discs having a diameter of 1.25 inches were saturated with methylene dianiline dissolved in Dowanol 50B. The patches were applied every other day for 15 applications to the skin of fifty subjects. Results were graded and recorded upon removal of the patches. Twenty-four hours after removal, the sites were examined for delayed reactions. The material was originally applied as a 5% solution in Dowanol 50B. After the second application, the concentration was reduced to 2.5%. 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.

Results and discussion

Results of examinations:

Positive result:
1st reading, 0 h after challenge, concentration of application 1%, 4/50 subjects had positive reactions.

Applicant's summary and conclusion

Conclusions:

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