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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
September 8-11, 1998
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report date:
1998

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
(2S-cis)-2,3-dihydro-3-hydroxy-2-(4-methoxyphenyl)-1,5-benzothiazepin-4(5H)-one
EC Number:
255-799-0
EC Name:
(2S-cis)-2,3-dihydro-3-hydroxy-2-(4-methoxyphenyl)-1,5-benzothiazepin-4(5H)-one
Cas Number:
42399-49-5
Molecular formula:
C16H15NO3S
IUPAC Name:
(2S-cis)-2,3-dihydro-3-hydroxy-2-(4-methoxyphenyl)-1,5-benzothiazepin-4(5H)-one
Details on test material:
Identification: DTZ62
Characteristics: white powder
Storage conditions: room temperature in the original container

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
The rabbits were about 2 – 3 months old and weighed about 2.5 – 2.8.
All animals were clinically observed and 20% of them were weighed: their weight conformed to that required. The animals were housed in the same room in which the treatment was performed.
Animal room controls were set to maintain temperature and relative humidity at 20°C ± 2 and 50% ± 15, respectively. There were approximately 20air changes per hour. The room was illuminated by artificial lighting with a 12 hour circadian cycle (7 a.m. – 7 p.m.).
the contents of the batches of diet used in this study were within ± 5% of the declared values and the presence and the levels of contaminants were within the limits proposed by EPA-TSCA. The diet was available “ad libitum” to the animals.

Test system

Type of coverage:
occlusive
Preparation of test site:
other: intact skin
Vehicle:
water
Controls:
no
Amount / concentration applied:
Dose administered: 0.5 g/site
Duration of treatment / exposure:
3 minutes, 1 hour and 4 hours
Observation period:
Immediately and 72 hours after the 3 minute and the 1 hour exposure period in the first rabbit and at 1, 24, 48 and 72 hours after the 4-hour exposure period (all rabbits).
Number of animals:
3 males

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 3 minutes, 1 hour and 4 hours
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 3 minutes, 1 hour and 4 hours
Score:
0
Max. score:
0
Other effects:
Neither mortality nor adverse general clinical modifications were seen during the study.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test article DTZ 62 when administered to rabbits by dermal route, is to be considered “NON IRRITANT” for the skin.