Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2007
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Recent study according to current regulations; no GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report date:
2007

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
no
GLP compliance:
no
Type of study:
mouse local lymph node assay (LLNA)

Test material

Constituent 1
Chemical structure
Reference substance name:
Xanthylium, 9-(2-carboxyphenyl)-3,6-bis(diethylamino)-, 4-[(5-chloro-2-hydroxyphenyl)azo]-4,5-dihydro-3-methyl-1-phenyl-3H-pyrazol-3-one 4,5-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-3-methyl-1-phenyl-3H-pyrazol-3-one 3-[[1-[[(2-ethylhexyl)amino]carbonyl]-2-oxopropyl]azo]-2-hydroxy-5-nitrobenzoate cobaltate complexes
EC Number:
276-160-2
EC Name:
Xanthylium, 9-(2-carboxyphenyl)-3,6-bis(diethylamino)-, 4-[(5-chloro-2-hydroxyphenyl)azo]-4,5-dihydro-3-methyl-1-phenyl-3H-pyrazol-3-one 4,5-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-3-methyl-1-phenyl-3H-pyrazol-3-one 3-[[1-[[(2-ethylhexyl)amino]carbonyl]-2-oxopropyl]azo]-2-hydroxy-5-nitrobenzoate cobaltate complexes
Cas Number:
71888-93-2
Molecular formula:
C63H66ClN10O12xCo
IUPAC Name:
Xanthylium, 9-(2-carboxyphenyl)-3,6-bis(diethylamino)-, 4-[(5-chloro-2-hydroxyphenyl)azo]-4,5-dihydro-3-methyl-1-phenyl-3H-pyrazol-3-one 4,5-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-3-methyl-1-phenyl-3H-pyrazol-3-one 3-[[1-[[(2-ethylhexyl)amino]carbonyl]-2-oxopropyl]azo]-2-hydroxy-5-nitrobenzoate cobaltate complexes

In vivo test system

Test animals

Species:
mouse
Strain:
CBA
Sex:
female
Details on test animals and environmental conditions:
Mice, CBA/CaOlaHsd, (nulliparous and non-pregnant), 7 - 12 weeks

Study design: in vivo (LLNA)

Vehicle:
acetone/olive oil (4:1 v/v)
Concentration:
6.25, 12.5, and 25 % (w/v)
No. of animals per dose:
4
Details on study design:
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: OECD 429
- Criteria used to consider a positive response: A test item is regarded as a sensitiser in the LLNA if the following criteria are fulfilled:
- First, that exposure to at least one concentration of the test item resulted in an incorporation of 3HTdR at least 3-fold or greater than that recorded in control mice, as indicated by the stimulation index.
- Second, that the data are compatible with a conventional dose response, although allowance must be made (especially at high topical concentrations) for either local toxicity or immunological suppression.

Positive control substance(s):
hexyl cinnamic aldehyde (CAS No 101-86-0)

Results and discussion

Positive control results:
The stimulation index for the control substance was determined as 2,43 - 4,07 - 4,88 depending on the concentration used (5 - 10 - 25% resp.)

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Remarks on result:
other: 1,62
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: see below

Any other information on results incl. tables

Test item Concentration

Group

DPM

 

Calculation

 

Result

 

 

 

DPM-BG

Lymph nodes (LN)

DPM/LN

SI

 

BG I

30,89

 

 

 

 

 

BG II

21,80

 

 

 

 

 

1

4547,15

4520,8

8

565,1

 

6,25

2

6943,98

6917,6

8

864,7

1,53

12,5

3

6392,05

6365,7

8

765,7

1,41

25

4

7372,63

7346,3

8

918,3

1,62

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test item did not show a sensitisation potential in the LLNA in female mice.
Executive summary:

In the study the test item dissolved in acetone:olive oil (4+1) was assessed for its possible contact allergenic potential. For this purpose a local lymph node assay was performed in female mice using test item concentrations of 6.25, 12.5, and 25 %. The animals did not show any clinical signs during the course of the study and no cases of mortality were observed.

In this study Stimulation Indices (S.I.) of 1.53, 1.41, and 1.62 were determined with the test item at concentrations of 6.25, 12.5, and 25 % in acetone:olive oil (4+1), respectively. The test item was not a skin sensitiser in this assay. The EC3 value could not be calculated, since all S.I. were below 3.