Hydrogen [1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphtholato(2-)][1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphtholato(2-)]chromate(1-) , compound with 3-[(2-ethylhexyl)oxy]propylamine (1:1)

Skin sensitisation

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: Guideline study without GLP; well documented, full report; only 1 concentration tested, however far above the solubility in water

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:

yes

Remarks:

only 1 concentration tested, however far above the solubility in water

GLP compliance:

no

Type of study:

mouse local lymph node assay (LLNA)

Test material

Test material information

Constituent 1

Reference substance name:

Hydrogen [1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphtholato(2-)][1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphtholato(2-)]chromate(1-) , compound with 3-[(2-ethylhexyl)oxy]propylamine (1:1)

EC Number:

276-857-1

EC Name:

Hydrogen [1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphtholato(2-)][1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphtholato(2-)]chromate(1-) , compound with 3-[(2-ethylhexyl)oxy]propylamine (1:1)

Cas Number:

72812-34-1

Molecular formula:

C32H18CrN6O8.C11H25NO.H

IUPAC Name:

Chromate(1-), [1-[2-[2-(hydroxy-kO)-4-nitrophenyl]diazenyl-kN1]-2-naphthalenolato(2-)-kO][1-[2-[2-(hydroxy-kO)-5-nitrophenyl]diazenyl-kN1]-2-naphthalenolato(2-)-kO]-, hydrogen, compd. with 3-[(2-ethylhexyl)oxy]-1-propanamine (1:1:1)

In vivo test system

Test animals

Species:

mouse

Strain:

CBA

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: Harlan Netherlands; B.V. Postbus 6174L; NL - 5960 AD Horst / The Netherlands
- Age at study initiation: 7 - 8 weeks
- Weight at study initiation: 17,7 -19,6 g
- Housing: single
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: yes

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 + 3
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (LLNA)

Vehicle:

dimethyl sulphoxide

Concentration:

25 %

No. of animals per dose:

4

Positive control substance(s):

hexyl cinnamic aldehyde (CAS No 101-86-0)

Results and discussion

Positive control results:

At a concentration of 10 % a stimulation index of 4.07 was produced.

In vivo (LLNA)

Results

Results 1

Parameter:

SI

Remarks on result:

other: 2,2

Results 2

Parameter:

other: disintegrations per minute (DPM)

Remarks on result:

other: Group DPM BG I 23,72 BG II 19,95 1 6360,36 2 14125,80 Further details see table 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	23,72
	BG II	19,95
	1	6360,36	6338,5	8	792,3	1
25	2	14125,80	14104,0	8	1763,0	2,2

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 found to be not a skin sensitiser under the described conditions.

Executive summary:

In the study the test item dissolved in dimethyl sulfoxide was assessed for its possible contact allergenic potential

For this purpose a local lymph node assay was performed using a test item concentration of 25%.

The animals did not show any clinical signs during the course of the study and no cases of mortality were observed. Due to the intense colour of the test item reddening of the ear skin could not be evaluated.

In this study a Stimulation Index (S.I.) of 2.2 was determined with the test item at a concentration of 25% in dimethyl sulfoxide, respectively.

The test item was not a skin sensitiser in this assay.