tert.butyl amine salt of (+)-(3R, 5S)-7[4-(4-Fluorophenyl)-6-Isopropyl-2 [methyl-(methylsulfonyl amino] pyrimidin-5-yl]-3,5- dihydroxy-6(E)- heptenoic acid

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:

2009

Report date:

2009

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

tert.butyl amine salt of (+)-(3R, 5S)-7[4-(4-Fluorophenyl)-6-Isopropyl-2 [methyl-(methylsulfonyl amino] pyrimidin-5-yl]-3,5- dihydroxy-6(E)- heptenoic acid

Cas Number:

917805-74-4

Molecular formula:

C26H39FN4O6S

IUPAC Name:

tert.butyl amine salt of (+)-(3R, 5S)-7[4-(4-Fluorophenyl)-6-Isopropyl-2 [methyl-(methylsulfonyl amino] pyrimidin-5-yl]-3,5- dihydroxy-6(E)- heptenoic acid

Test material form:

solid: particulate/powder

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: S&K-LAP Kft., Kartal, Hungary
- Age at study initiation: 10 weeks old, adult rabbit
- Weight at study initiation: 2709-2890 g
- Housing: animal were housed individually in metal cages
- Diet (e.g. ad libitum): Hare fattening mixed diet produced by YAO-TÁP Kft., Nyíregyháza (Tokaji út 22), Hungary, ad libitum
- Water (e.g. ad libitum): tap water from watering bottles ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+/- 3 °C
- Humidity (%): 30-70 %
- 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

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: approximately 6 cm2
- Type of wrap if used: sterile gauze pads (10*10 cm) were fixed with surrounding adhesive hypoallergic plaster; the entire trunks of the animals were wrapped with plastic wrap for 4 hours

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:

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

Score:

0

Max. score:

0

Reversibility:

other: no signs

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

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

Score:

0

Max. score:

0

Reversibility:

other: no signs

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

72 hours after the treatment the study was terminated, since there were no primary irritation symptoms.

The animals' individual mean scores (considering readings at 24, 48 and 72 hours after patch removal) for erythema and oedema were 0.00, 0.00 and 0.00 respectively.

Other effects:

During the study the general state and behaviour of animals were normal.

There were no notable body weight changes during the contact and observation period.

Applicant's summary and conclusion

Interpretation of results:

other: not irritating

Conclusions:

According to EEC directive 2001/59/EEC, the test item Rosuvastatin TBA salt (EGIS-14660-3) has not been classified as irritating for the skin.