Thieno[3,2-c]pyridine-5(4H)-acetic acid, .alpha.-(2-chlorophenyl)-6,7-dihydro-, methyl ester, (.alpha.S)-, (1R,4S)-7,7-dimethyl-2-oxobicyclo[2.2.1]heptane-1-methanesulfonate (1:1)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2002

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

[(1R)-7,7-dimethyl-2-oxobicyclo[2.2.1]hept-1-yl]methanesulfonic acid - methyl(2S)-(2-chlorophenyl)(6,7-dihydrothieno[3,2-c]pyridin-5(4H)-yl)acetate (1:1)

EC Number:

601-680-7

Cas Number:

120202-68-8

Molecular formula:

C16H16ClNO2S.C10H16O4S

IUPAC Name:

[(1R)-7,7-dimethyl-2-oxobicyclo[2.2.1]hept-1-yl]methanesulfonic acid - methyl(2S)-(2-chlorophenyl)(6,7-dihydrothieno[3,2-c]pyridin-5(4H)-yl)acetate (1:1)

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Ferenc Sandor breeder , Kartal, Hungary
- Age at study initiation: adult albino rabbits
- Weight at study initiation: 3048-3389 g
at study termination: 3146-3507 g
- Housing: individually in metal cages.
- Diet (e.g. ad libitum): ad libitum, PURISTAR standard diet (AGRIBRANDS EUROPE)
- Water (e.g. ad libitum): ad libitum, potable water from automatic self-service water system
- Acclimation period: 26 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 50 ± 20 %
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated skin of each animal served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g test item, in pure state, in a single dose

VEHICLE
No vehicle was applied

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: appr. 6 cm2
- Type of wrap if used: sterile gauze patch fixed with adhesive hypoallergenic plaster

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with body temperature water
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize (1959)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

for each animal

Time point:

other: 1 h, 24 h, 48 h, 72 h

Score:

0 - 1

Max. score:

1

Reversibility:

fully reversible within: 48 h

Remarks on result:

other: very slight reversible erythema in two animals

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

for each animal

Time point:

other: 1 h, 24 h, 48 h, 72 h

Score:

0

Max. score:

0

Reversibility:

other: no signs

Irritant / corrosive response data:

Very slight erythema was observed in two animals.
24 hours after patch removal the irritation symptoms have not changed.
48 and 72 hours after patch removal, every animal was symptom free.
Combined irritation index: 0.33

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

On the basis of the results of the present study the test item is non-irritant.