6-Heptenoic acid, 7-[4-(4-fluorophenyl)-6-(1-methylethyl)-2-[methyl(methylsulfonyl)amino]-5-pyrimidinyl]-3,5-dihydroxy-, methyl ester, (3R,5S,6E)-

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2010

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

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:

Methyl(3R,5S,6E)-7-{4-(4-fluorophenyl)-6-(1-methylethyl)-2-[methyl(methylsulfonyl)amino]pyrimidin-5-yl}-3,5-dihydroxyhept-6-enoate

Cas Number:

147118-40-9

Molecular formula:

C23H30FN3O6S

IUPAC Name:

Methyl(3R,5S,6E)-7-{4-(4-fluorophenyl)-6-(1-methylethyl)-2-[methyl(methylsulfonyl)amino]pyrimidin-5-yl}-3,5-dihydroxyhept-6-enoate

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: adult rabbits- Weight at study initiation: 2986-3108 g at study termination: 3022-3194 g- Housing: individually in metal cages.- Diet (e.g. ad libitum): ad libitum, Hare fattening mixed diet (YAQ-TÁP Kft)- Water (e.g. ad libitum): ad libitum, tap water from watering bottles ad libitum- Acclimation period: 5 daysENVIRONMENTAL 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:

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 doseVEHICLE No vehicle was applied

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

3 males

Details on study design:

TEST SITE- Area of exposure: appr. 6 cm2- Type of wrap if used: sterile gauze pads (10x10 cm) were fixed with a surrounding adhesive hypoallergenic 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 hoursSCORING 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

Max. score:

0

Reversibility:

other: no signs

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:

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

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

According to EC directive 2001/59/EC, the test item has not been classified as irritationg for the skin.According to Regulation EC No. 1272/2008, the test item has not been classified into any cathegory.