Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 500-036-1 | CAS number: 25214-70-4
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation
- Remarks:
- in vivo
- 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:
- 1 954
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 substance name:
- methylene dianiline
- IUPAC Name:
- methylene dianiline
- 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
Constituent 1
Constituent 2
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 chemical
- 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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
