Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.

Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Research study using recognised guideline techniques but lacking full data reporting.

Data source

Reference
Reference Type:
publication
Title:
Is toluene diamine a sensitizer and is there cross-reactivity between toluene diamine and toluene diisocyanate?
Author:
Vanoirbeek JAJ, De Vooght V, Synhaeve N, Nemery B & Hoet PHM
Year:
2009
Bibliographic source:
Toxicol.Sci. 109 (2): 256-64)

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
GLP compliance:
not specified
Remarks:
Publication does not specify GLP compliance
Type of study:
mouse local lymph node assay (LLNA)

Test material

Constituent 1
Chemical structure
Reference substance name:
4-methyl-m-phenylenediamine
EC Number:
202-453-1
EC Name:
4-methyl-m-phenylenediamine
Cas Number:
95-80-7
Molecular formula:
C7H10N2
IUPAC Name:
4-methylbenzene-1,3-diamine
Details on test material:
Toluene-2,4-diamine (98%)

In vivo test system

Test animals

Species:
mouse
Strain:
Balb/c
Sex:
male

Study design: in vivo (non-LLNA)

No. of animals per dose:
5

Study design: in vivo (LLNA)

Vehicle:
acetone/olive oil (4:1 v/v)
Concentration:
5, 10, 15,, 20, 25 percent
No. of animals per dose:
5

Results and discussion

Any other information on results incl. tables

Please see attached figure.

Applicant's summary and conclusion

Interpretation of results:
other: Weakly sensitising
Conclusions:
The study found TDA to be weakly sensitising to skin in this model with an EC3 of 19%.