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Toxicological information

Skin sensitisation

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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:
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

Reference
Name:
Unnamed
Type:
Constituent
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:
sensitising
Remarks:
Migrated information weakly sensitizing (1B) Criteria used for interpretation of results: EU
Conclusions:
The study found TDA to be weakly sensitising to skin in this model with an EC3 of 19%.