3,4-Dichloro-N-(5-chloro-4-{[2-({4-[(2-hexyldecyl)oxy]phenyl}sulfonyl)butanoyl]amino}-2-hydroxyphenyl)benzamide

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

from 2005 january 24th to 2005 february 15th

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study performed according to the OECD Guideline 429.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)

GLP compliance:

yes

Type of study:

mouse local lymph node assay (LLNA)

Test material

Reference

Name:

Unnamed

Type:

Constituent

Details on test material:

Sponsor's identification EKC 2003-0115
Description : off white solid
Batch number : DEV75332
Date received : 26 November 2004
Storage conditions : room temperature in the dark

In vivo test system

Test animals

Species:

mouse

Strain:

CBA

Sex:

female

Details on test animals and environmental conditions:

Female CBNCa (CBNCaBkl) strain mice were supplied by B & K Universal Ltd, Hull, UK and
(CBNCa CruBR) strain mice were supplied by Charles River UK Limited, Margate, Kent, UK.
On receipt the animals were randomly allocated to cages. The animals were nulliparous and
non-pregnant. After an acclimatisation period of at least five days the animals were selected at
random and given a number unique within the study by indelible ink-marking on the tail and a
number written on a cage card. At the start of the study the animals were in the weight range of
15 to 23 g, and were eight to twelve weeks old.
The animals were individually housed in suspended solid-floor polypropylene cages furnished
with softwood woodflakes. Free access to mains tap water and food (Certified Rat and Mouse
Diet (Code 5LF2) supplied by BCM IPS Limited, London, UK) was allowed throughout the
study.
The temperature and relative humidity were controlled to remain within target ranges of 19 to
25°C and 30 to 70% respectively. Any occasional deviations from these targets were considered
not to have affected the purpose or integrity of the study. The rate of air exchange was
approximately fifteen changes per hour and the lighting was controlled by a time switch to give
twelve hours continuous light (06.00 to 18.00) and twelve hours darkness.
The animals were provided with environmental enrichment items which were considered not to
contain any contaminant of a level that might have affected the purpose or integrity of the study.

Study design: in vivo (LLNA)

Vehicle:

dimethylformamide

Concentration:

The dose levels selected for the main test were 2.5%, 5% and 10% w/w in dimethyl formamide.

No. of animals per dose:

A preliminary screening test was performed using two mice.
Groups of five mice were treated with the test material at concentrations of 2.5%, 5% or 10% w/w in dimethyl formamide.
A further group of five mice received the vehicle alone in the same manner.

Positive control substance(s):

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

Results and discussion

In vivo (LLNA)

Results

Results 1

Parameter:

SI

Remarks on result:

other: A stimulation index of less than 3 was recorded for the three concentrations of the test material (2.5%, 5% and 10% w/w).

Results 2

Parameter:

other: disintegrations per minute (DPM)

Remarks on result:

other: see Remark

Remarks:

Vehicle : animal 1-1 : 901.85 animal 1-2 : 1332.08 animal 1-3 : 1602.02 animal 1-4 : 1834.32 animal 1-5 : 1717.40 Mean Dpm (Standard Deviation) : 1477.53 (371.79) concentration 2.5% : animal 2-1 : 1189.45 animal 2-2 : 1053.80 animal 2-3 : 1504.06 animal 2-4 : 1295.48 animal 2-5 : 1864.03 Mean Dpm (Standard Deviation) : 1381.36 (316.04) concentration 5% : animal 3-1 : 968.26 animal 3-2 : 736.47 animal 3-3 : 1457.51 animal 3-4 : 808.81 animal 3-5 : 1937.48 Mean Dpm (Standard Deviation) : 1181.71 (507.47) concentration 5% : animal 3-1 : 968.26 animal 3-2 : 736.47 animal 3-3 : 1457.51 animal 3-4 : 808.81 animal 3-5 : 1937.48 Mean Dpm (Standard Deviation) : 1181.71 (507.47) concentration 10% : animal 4-1 : 1272.02 animal 4-2 : 1758.94 animal 4-3 : 2425.29 animal 4-4 : 1436.62 animal 4-5 : 1342.74 Mean Dpm (Standard Deviation) : 1647.12 (473.21)

Any other information on results incl. tables

The results of the statistical analysis of the data indicated there was no significant difference between the control group and the test groups.

Clinical Observations and Mortality Data

There were no deaths. No signs of systemic toxicity were noted in the test or control animals.

Bodyweight

Bodyweight changes of the test animals between Day 1 and Day 6 were comparable to those observed in the corresponding control group animals over the same period.

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information

Conclusions:

The test material was considered to be a non-sensitiser under the conditions of the test.

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