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Diss Factsheets

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
October to November 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:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

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

Test animals

Species:
rabbit
Strain:
Himalayan
Details on test animals or test system and environmental conditions:
TEST ANIMALS
2 m and 2 f rabbits, Chbb:HM (Himalayan)
Weight: 2.1 - 2.7 kg
Age : 19 - 22 weeks
Acclimatization period: > 2 weeks
Supplier: Dr. Karl Thomae GmbH

ENVIRONMENTAL CONDITIONS
Individual accommodation in stainless steel wire cages, with a floor area of 3878 cm2.
Temperature: 22 +3 -1°C;
Relative humidity: 55 (50 - 65) %.
A cycle of 12:12 hrs. light: darkness was maintained.

Feed
Standardized pelleted feed 9980 (Altromin, Lage). Certificates of analysis relating to nutritional content and presence of contaminants of the batches used are kept in the archives of the Laboratory Animal Services Unit of Boehringer lngelheim .

Drinking water
Filtered, demineralized water of drinking quality was adjusted to pH 2.6 ±
0.2 with hydrochloric acid and was freely available to the animals.


Duration and date of the study
1 week
26.10.1994 - 02.11.1994

Test system

Type of coverage:
other: occlusive right side | semi-occlusive on the left side
Preparation of test site:
clipped
Vehicle:
physiological saline
Controls:
yes
Amount / concentration applied:
0.3 g test article moistened with 0.5 ml physiological saline, or 0.5 ml physiological saline2) as control, was applied once to a 3 x 3 cm square area of shaved skin.
Duration of treatment / exposure:
4 hrs
Observation period:
The state of health and behaviour of the animals were checked twice daily and abnormalities were recorded in writing. On Saturdays, Sundays, and holidays, the clinical observations were carried out only once daily.
Number of animals:
2 male rabbits
2 female rabbits
Details on study design:
The technique employed in this study was based on that described by Draize (1959)1) and on the OECD Guidelines for the Testing of Chemicals, 404, 17.07.1992, as well with reference to EC Regulation no. L383A, dated 29.12.1992.

The animals were prepared by shaving the dorsal region with electric clippers 15 - 24 hours before topical application. Only animals with healthy, smooth, and intact skin were employed in the study.

0.3 g test article moistened with 0.5 ml physiological saline, or 0.5 ml physiological saline2) as control, was applied once to a 3 x 3 cm square area of shaved skin.

The test article or physiological saline was applied and covered with the aid of gauze bandage patches (3 x 3 cm), on the right side occlusively3) (airtight) and on the left side semi-occlusively4) (with plaster), and enclosed in a protective bandage5)_ After 4 hours the gauze patches were removed.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 1/24/72h and 1 week
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 1/24/72h and 1 week
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 1/24/72h and 1 week
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 1/24/72h and 1 week
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 1/24/72h and 1 week
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 1/24/72h and 1 week
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #4
Time point:
other: 1/24/72h and 1 week
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
other: 1/24/72h and 1 week
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation

Applicant's summary and conclusion

Interpretation of results:
other: not classified according to CLP
Conclusions:
SND 919 CL2 Y Precursor 1 = SND 919 Thiazol was evaluated as having no irritant potential.