Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Only short study summary

Data source

Reference
Reference Type:
other: Material Safety Data Sheet
Title:
Material Safety Data Sheet
Author:
Chemada Fine Chemicals Ltd., Israel
Year:
2009
Bibliographic source:
Chemada Fine Chemicals Ltd. 22/03/2009 Material Safety Data Sheet CAS number 821-06-7

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
no
Principles of method if other than guideline:
No data
GLP compliance:
yes
Type of study:
mouse local lymph node assay (LLNA)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Analytical purity: 98%

In vivo test system

Test animals

Species:
mouse
Strain:
other: CBA/Ca
Sex:
not specified
Details on test animals and environmental conditions:
No data

Study design: in vivo (LLNA)

Vehicle:
acetone/olive oil (4:1 v/v)
Concentration:
0
0.25
0.5
1.0
No. of animals per dose:
4 animals per dose
Details on study design:
No data
Statistics:
No data

Results and discussion

Positive control results:
No data

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Remarks on result:
other: see Remark
Remarks:
Concentration (%v/v) in aceton/olive oil 1:4 Stimulation index 0.25 5.08 0.5 5.27 1 6.30
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: No data

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information
Conclusions:
According to the described method the test substance trans-1,4 -Dibromo-2 -butene is classified as sensitiser following EU ( R43: May cause sensitisation by skin contact) and GHS (Skin Sens. 1) requirements.
Executive summary:

According to the described method the test substance trans-1,4 -Dibromo-2 -butene is classified as sensitiser following EU (R43: May cause sensitisation by skin contact) and GHS (Skin Sens. 1) requirements.