4-amino-5-hydroxy-6-(5-{4-chloro-6-[4-(2-sulfonatooxyethanesulfonyl)phenylamino]-1,3,5-triazin-2-ylamino}-2-sulfonatophenylazo)-3-(2-sulfonato-4-(2-sulfonatooxyethanesulfonyl)phenylazo)naphthalene-2,7-disulfonate potassium/sodium;reaction mass of: 4-amino-3-(4-ethenesulfonyl-2-sulfonatophenylazo)-5-hydroxy-6-(5-{4-chloro-6-[4-(2-sulfonatooxyethanesulfonyl)phenylamino]-1,3,5-triazin-2-ylamino}-2-sulfonatophenylazo)naphthalene-2,7-disulfonate potassium/sodium

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

May 21 to June 04, 2003

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

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

Details on test material:

Identity : FAT40'815/A
Description : Dark shining solid
Batch number : WP 8/03
Purity : Approx. 75 %
Composition : Confidential information; available in Sponsor's file. Was excluded from the Statement of Compliance.
Stability of test item : Stable under storage conditions
Expiry date : 01-MAY-2010
Stability of test item formulation : Unknown and therefore excluded from the Statement of Compliance.
Storage conditions : In the original container at room temperature (20 °C ± 3 °C), away from direct sunlight.

In vivo test system

Test animals

Species:

mouse

Sex:

female

Details on test animals and environmental conditions:

- Test system:Mice, CBA/CaOlaHsd
- Rationale : Recognized as the recommended test system.
- Source : Harlan Netherlands
B.V. Postbus 6174
NL - 5960 AD Horst / The Netherlands
- Number of animals for the pre-test (non-GLP) : 2 females
- Number of animals for the main study : 16 females
- Number of animals per group : 4 females (nulliparous and non-pregnant)
- Number of test groups : 3
- Number of control (vehicle) group : 1
- Age : 8-12 weeks (beginning of acclimatization)
- Body weight : 19.5 g - 22.9 g (beginning of acclimatization)
- Acclimatization : Under test conditions after health examination. Only animals without any visible signs of illness were used for the study.
- Husbandry conditions : Standard Laboratory Conditions. Air-conditioned with target ranges for room temperature 22 + 3 °C, relative humidity 30 - 70 % and 10 - 15 air changes per hour. Room temperature and humidity were monitored continuously and values outside of these ranges occasionally occurred, usually following room cleaning. These transient variations are considered not to have any influence on the study and, therefore, these data are not reported but are retained at RCC. There was a 12 hour fluorescent light / 12 hour dark cycle with at least 8 hours music during the light period.
- Diet : Pelleted standard Kliba 3433, batch no. 84/02 mouse maintenance diet (Provimi Kliba AG, CH-4303 Kaiseraugst) available ad libitum.
- Water : Community tap water from Itingen, available ad libitum.

Study design: in vivo (LLNA)

Vehicle:

other: ethanol/water

Concentration:

2.5 %, 5 % and 10 % (w/v) in ethanol:water, 7:3 (v/v) by topical application

No. of animals per dose:

four female
Control group of four mice

Results and discussion

Any other information on results incl. tables

	Test item concentration % (w/v)	STIMULATION INDEX (S.I.)
Group 2	2.5	1.1
Group 3	5	2.2
Group 4	10	2.0

No dose-response relation was observed. No test concentrations produced a STIMULATION INDEX (S.I.) of 3 or higher. Therefore, the test item is not sensitizer in the LLNA. No deaths occurred during the study period.

No symptoms of local toxicity at the ears of the animals and no systemic findings were observed during the study period.

The body weight of the animals, recorded at the start of acclimatization period and prior to necropsy, was within the range commonly recorded for animals of this strain and age.

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test item FAT 40'815/A was found to be a non-sensitizer when tested at up to the highest achievable concentration of 10 % (w/v) in the chosen vehicle.

Executive summary:

The skin sensitisation effect of FAT40815 was determined by an LLNA test in mice under GLP conditions and according to OECD Guideline 429. The concentrations 2.5 %, 5 % and 10 % (w/v) were tested but no test concentrations produced a Stimulation Index (S.I.) of 3 or higher. Therefore, the test item FAT 40'815/A was found to be a non-sensitizer when tested at up to the highest achievable concentration of 10 % (w/v) in the chosen vehicle.