3-ethyl 5-methyl 4-(2-chlorophenyl)-1,4-dihydro-2-[2-(1,3-dihydro-1,3-dioxo-(2H)isoindol-2-yl)-ethoxymethyl]-6-methyl-3,5-pyridinedicarboxylate

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)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

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:

3-ethyl 5-methyl 4-(2-chlorophenyl)-1,4-dihydro-2-[2-(1,3-dihydro-1,3-dioxo-(2H)isoindol-2-yl)-ethoxymethyl]-6-methyl-3,5-pyridinedicarboxylate

EC Number:

413-410-3

EC Name:

3-ethyl 5-methyl 4-(2-chlorophenyl)-1,4-dihydro-2-[2-(1,3-dihydro-1,3-dioxo-(2H)isoindol-2-yl)-ethoxymethyl]-6-methyl-3,5-pyridinedicarboxylate

Cas Number:

88150-62-3

Molecular formula:

C28H27ClN2O7

IUPAC Name:

3-ethyl 5-methyl 4-(2-chlorophenyl)-2-{[2-(1,3-dioxo-2,3-dihydro-1H-isoindol-2-yl)ethoxy]methyl}-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate

Test material form:

solid: crystalline

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: TETRABBIT , Hungary
- Age at study initiation: 10 weeks, adult
- Weight at study initiation: 3060-3348 g
at study termination: 3152-3402 g
- Housing: individually in metal cages.
- Diet (e.g. ad libitum): ad libitum, PURINA-Base - Lap gr.
- Water (e.g. ad libitum): ad libitum, potable water from automatic self-service water system
- Acclimation period: 21 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30-70 %
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

occlusive

Preparation of test site:

other: close-clipped

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 of Phthaloyl amlodipine, 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

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

Phthaloil Amlodipine has not been classified as irritating for the skin.

Other effects:

No primary irritation symptoms, such as erythema and oedema, or other signs occurred during the observation period.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In this in vivo skin irritation test of Amlodipine phthaloyl the results indicated that the test item is Non Irritant.