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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
24 april 2013 to 07 may 2013
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report date:
2013

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of study:
mouse local lymph node assay (LLNA)

Test material

Constituent 1
Reference substance name:
Reaction mass of disodium 2-{[2-(carbamoylamino)-4-({4-chloro-6-[(3-sulfonatophenyl)amino]-1,3,5-triazin-2-yl}amino)phenyl]diazenyl}-5-(vinylsulfonyl)benzenesulfonate and trisodium 2-{[2-(carbamoylamino)-4-({4-chloro-6-[(3-sulfonatophenyl)amino]-1,3,5-triazin-2-yl}amino)phenyl]diazenyl}-5-{[2-(sulfonatooxy)ethyl]sulfonyl}benzenesulfonate
IUPAC Name:
Reaction mass of disodium 2-{[2-(carbamoylamino)-4-({4-chloro-6-[(3-sulfonatophenyl)amino]-1,3,5-triazin-2-yl}amino)phenyl]diazenyl}-5-(vinylsulfonyl)benzenesulfonate and trisodium 2-{[2-(carbamoylamino)-4-({4-chloro-6-[(3-sulfonatophenyl)amino]-1,3,5-triazin-2-yl}amino)phenyl]diazenyl}-5-{[2-(sulfonatooxy)ethyl]sulfonyl}benzenesulfonate
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
radio-labelled thymidine: 3H-methyl thymidine)

In vivo test system

Test animals

Species:
mouse
Strain:
CBA
Sex:
female

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
other: epidermal topical application
Vehicle:
other: ethanol/water (3+7 v/v)
Concentration / amount:
5; 10 and 20 %
Challenge
Concentration / amount:
5; 10 and 20 %
No. of animals per dose:
4

Study design: in vivo (LLNA)

Vehicle:
other: ethanol/water (3+7, v/v)
Concentration:
5, 10 and 25 % (w/w)
No. of animals per dose:
4
Positive control substance(s):
hexyl cinnamic aldehyde (CAS No 101-86-0)

Results and discussion

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Remarks on result:
other: 1.0 1.2 1.0 2.9
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: 112.2 129.1 116.2 323.7

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test item was not a skin sensitiser under the test conditions of this study.