Sodium bis[3-[[1-(3-chlorophenyl)-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-4-yl]azo]-4-hydroxy-N-methylbenzene-1-sulphonamidato(2-)]chromate(1-)

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2005

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Stabdard Guideline study under GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)

GLP compliance:

yes (incl. QA statement)

Type of study:

mouse local lymph node assay (LLNA)

Test material

Test material information

Constituent 1

Reference substance name:

Savinyl Orange RLS

IUPAC Name:

Savinyl Orange RLS

In vivo test system

Test animals

Species:

mouse

Strain:

CBA

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: Harlan Netherlands; BV Postbus 6174; NL- 5960 AD Horst/ The Netherlands
- Age at study initiation: 8- 12 weeks
- Weight at study initiation: 17,7 g
- Housing: single
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 30-70%

- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (LLNA)

Vehicle:

methyl ethyl ketone

Concentration:

5.0, 10.0, and 25.0 % (w/v)

No. of animals per dose:

4

Details on study design:

RANGE FINDING TESTS:

- Irritation: inhibited by intense color of test item


MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT

- 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 positiv control substance produced a SI value of 3,0 at 10 %.

In vivo (LLNA)

Results

Key result

Parameter:

SI

Value:

> 1.5 - < 2.1

Variability:

Values of 1.5 to 2.1 were determined at concentrations of 5 to 25 %

Remarks on result:

other: See table below

Any other information on results incl. tables

Test item concentration % (w/v)	Group	Measurement		Calculation		Result
		DPM	DPM-BG a)	DPM per Lymph node	Lymph nodes	S.I.
---	BG I	20,3	---	---	---	---
---	BG II	0.0
---	CG 1	2653.1	2643.0	330.4	8
5.0	TG2	3982.2	3972.1	496,5	8	1.5
10.0	TG 3	5534.8	5524.7	690.6	8	2.1
25.0	TG4	5385.4	5375.3	671.9	8	2.0

BG = Background (1 ml 5% trichloroacetic acid) in duplicate

CG = Control Group

TG = Test Group

S.I = Stimulation Index

a) = The mean value was taken from the figures BG I and BG II

b) = Since the lymph nodes of the animals of a dose group were pooled, DPM/node was determined by dividing the measured value by the number of lymph nodes pooled

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 conditions of this LLNA in female mice.

Executive summary:

In the study the test item dissolved in methyl ethyl ketone was assessed for its possible contact allergenic potential.

For this purpose a local lymph node assay was performed in female CBA mice using test item concentrations of 5.0, 10.0, and 25.0%.

The animals did not show any clinical signs during the course of the study and no cases of mortality observed.

In this study Stimulation Indices (S.L) of 1.5, 2.1 and 2.0 were determined with the test item at concentrations of 5 0, 1 0.0, and 25 .. 0% (w/v) in methyl ethyl ketone, respectively.

Thus, the test item Savinyl Orange RLS was not a skin sensitiser.