Registration Dossier

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: acceptable, well-documented publication which meets basic scientific principles

Data source

Reference
Reference Type:
publication
Title:
Ranking of allergic potency of rubber chemicals in a modified local lymph node assay
Author:
De Jong, W., H.; et al.
Year:
2002
Bibliographic source:
Toxicological Sciences 66, 226-232

Materials and methods

Principles of method if other than guideline:
Local lymph node assay (using ex vivo labeling of proliferating lymph node cells, according to Kimber and Weisberger 1989 Arch. Toxicol. 63, 274-282, Vanebriel et al 2000 Toxicol. Appl. Pharmacol 162, 77-85, Van Och et al. 2000 Toxicology 146, 49-59
GLP compliance:
no
Type of study:
mouse local lymph node assay (LLNA)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
MBTS, purity: 99%

In vivo test system

Test animals

Species:
mouse
Strain:
Balb/c
Sex:
female

Study design: in vivo (LLNA)

Vehicle:
acetone/olive oil (4:1 v/v)
Concentration:
no data
No. of animals per dose:
3 per dose group, control 6

Results and discussion

In vivo (LLNA)

Results
Parameter:
SI
Remarks on result:
other: EC3: 2.9%

Any other information on results incl. tables

MBTS: EC3*: 2.9 % (L05 -L95: 1.4 - 6.7, estimated 90% confidence interval based on 200 bootstrap runs)

*effective concentration inducing a stimulation index of 3 in LLNA

Moderate skin sensitzing

Applicant's summary and conclusion

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

The test substance MBTS is classified as skin sensitiser according regulation no. 1272/2008 (GHS).