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Diss Factsheets

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
September to October 1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report date:
1995

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
not specified
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The Guinea Pig Maximization Test according to Magnusson and Kligman (Magnusson and Kligman, 1969 and Magnusson, 1980) is recognized by the OECD as skin sensitization test and is recommended by EEC Guideline as a reference method

Test material

Constituent 1
Chemical structure
Reference substance name:
N-(2-Methyl-4,5,6,7-tetrahydro-benzothiazol-6-yl)-acetamide hydrobromide
EC Number:
600-588-4
Cas Number:
104617-50-7
Molecular formula:
C9 H13 O N3 S x HBr
IUPAC Name:
N-(2-Methyl-4,5,6,7-tetrahydro-benzothiazol-6-yl)-acetamide hydrobromide

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Interfauna company, Tuttlingen
- 30 females
- Microbiological status of animals, when known:
- Age at study initiation: 45 - 49 days
- Weight at study initiation: 510.7g ±36.1

- Housing: Conventional keeping in room number 222 of the small animal house I. Individual accommodation in Makrolon cages type IV with litter consisting of soft wood granulate (Lignocel, type 3/4, manufactured by Rettenmayer & Sohne, Holzmuhle).

- Diet (e.g. ad libitum): sniff guinea pig feed from Sniff, Soest, was offered ad libitum to the animals during the entire duration of the study.
Analysis certificates stored at the Experimental Animal Breeding and Keeping Group confirm the feed quality of the batch used during the study and the random checks for harmful substances.

- Water (e.g. ad libitum): Demineralized, filtered water adjusted to pH=2.6 ± 0.2 with hydrochloric acid was offered ad libitum animals, in bottles.


- Acclimation period: > 2 weeks


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°c + 3, - 1
- Humidity (%): about 55% (min. 50%, max. 65%)
- Photoperiod (hrs dark / hrs light): 12 : 12 hours (6.00 to 18.00 light)


Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
unchanged (no vehicle)
Concentration / amount:
Group 1 control:
0.1 ml of a 0.1% tween 80 solution,
0.1 ml of a 1:1 mixture of FCA and 0.9% NaCL solution
0.1 ml of a 1:1 mixture of FCA and 0.1% Tween 80 solution
Group 2 test group:
0.1 ml of a 0.25% test suspension
0.1 ml of a 1:1 mixture of FCA and 0.9% NaCl solution
0.1 ml of a 1:1 mixture of FCA and 0.5% test compound
Day(s)/duration:
first day of the study
Adequacy of induction:
not specified
Route:
epicutaneous, occlusive
Vehicle:
other: ethanol
Concentration / amount:
Group 1 control:
0.6 ml of absolute ethanol
Group 2 (test)
0.6 ml of 25 % suspension of the test compound in absolute ethanol
Day(s)/duration:
day 8
Adequacy of induction:
not specified
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
other: ethanol
Concentration / amount:
0.3 ml of 25% test compound solution in ethanol
Day(s)/duration:
day 22 of study
Adequacy of challenge:
not specified
No. of animals per dose:
10 per test group
Details on study design:
The method used was Magnusson and Kligman's "Guinea Pig Maximization Test", which is recognized by the OECD as skin sensitization test and is recommended by the European Community as a reference method.

SENSITIZATION PHASE:

The sensitization of the animals was carried out in two stages:
1. 1st day of study: 3 pairs of intradermal injections each
2. 8th day of study: dermal, occlusive administration (48 hours)

All experimental animals were shaved with the aid of an electric shear (Aeskulap, cutting head 1/20 mm) immediately before administration over an area of
appr. 4 x 6 cm2 on the back.

During the sensitization phase, the animals of the negative control group 1 were treated in an identical manner as the animals of the test group 2 but only with the solvents used.

On the first day of the study, the guinea pigs received 3 pairs of intradermal injections of 0.1 ml each into the dorsal skin
On the 8th day of the study, the same area on the back was shaved. A appr. 2 x 4 cm2 filter paper to which
0.6 ml of absolute ethanol (animals of group 1) or
0.6 ml of 25 % suspension of the test compound in absolute ethanol (animals of group 2) had been applied, was placed on the skin. The filter paper was covered with an occlusive plaster (from Beiersdorf) and secured with an elastic bandage (Self Adherent Wrap, No.1583, Coheban 3M, Medical Product Division).
The occlusive system was removed 48 hours after application.

CHALLENGE OF AN ALLERGIC REACTION:
On the 22nd day of the study all experimental animals were shaved over an area of appr. 3 x 3 cm2 on both flanks and were treated as described below:
- a appr. 2 x 2 cm2 filter paper to which 0.3 ml of a
25 % suspension of the test compound in absolute ethanol (left flank) or 0.3 ml of absolute ethanol (right flank) had been applied, was fixed to each of the flanks of the guinea pig with the aid of an occlusive plaster (from Beiersdorf) and secured with an elastic bandage.

The animals of group 1 and 2 were treated in an identical manner.

The occlusive system was removed 24 hours after the application and the area of application was immediately marked with a pen.

On the 24th and 25th day of the study, i.e. 24 and 48 hours after the removal of the occlusive dressings, both areas of application (left and right flanks) were evaluated on the basis of the following points
system:

0 - no reaction
1 - slight reddening (points or spots)
2 - moderate reddening of the whole area of application.
3 - severe reddening and swelling

All findings were recorded, together with date and signature



CLINICAL OBSERVATIONS:
During the entire study the animals were observed once daily in the morning and during the 48 or 24 hours closed patch treatment the guinea pigs were checked every hour in order to record any substance or treat­ ment related toxic signs or behavioural changes.
Challenge controls:
BODY WEIGHT CONTROLS:
As a general check of the state of health, all experimental animals were weighed on the 1st, 8th, 15th, 22nd and 25th day of the study. The mean body weight, the standard deviation and the increase in body weight were calculated for each group.
Positive control substance(s):
yes
Remarks:
absolute ethanol

Results and discussion

Positive control results:
In the pre-sensitized animals of the test group 2 the following skin reactions were observed at the observation times of the 24th day of the study:
- slight redness (points or spots), counted as 1 in the score system used, in one animal (No. 206) on the left plank.

As allergic skin reactions are counted all skin reactions scored 2 or >2 in the points system used.

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Group:
negative control
Dose level:
0.3 ml 25 % test compound in absolute ethanol and 0.3 ml absolute ethanol
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no skin reactions
Remarks on result:
no indication of skin sensitisation
Key result
Group:
test chemical
Dose level:
0.3 ml 25 % test compound in absolute ethanol and 0.3 ml absolute ethanol
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no skin reactions
Remarks on result:
no indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
other:
Remarks:
Migrated information
Conclusions:
In the sensitization test based on Magnusson and Kligman's "Guinea Pig Maximization Test", the substanee SND 919 CL2 Y PRECURSOR 1
(2-Amino-6-acetylamino-4,5,6,7-tetrahydrobenzothiazol*HBR) = SND 919 Thiazol did not induce an allergic reaction by skin contact in any of the 20 guinea pigs
treated.
Thus the substance SND 919 Thiazol revealed no sensitizing potential under the stated study conditions.