(1R,2S,5R)-2-isopropyl-N-(4-methoxyphenyl)-5-methylcyclohexanecarboxamide

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2009-01-20 to 2009-01-23

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

adopted 2002-04-24

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Version / remarks:

, 2004

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

date of inspection 2008-08-19

Test material

Test material information

Constituent 1

Reference substance name:

(1R,2S,5R)-N-(4-methoxyphenyl)-5-methyl-2-(propan-2-yl)cyclohexane-1-carboxamide

EC Number:

700-232-9

Cas Number:

68489-09-8

Molecular formula:

C18H27NO2

IUPAC Name:

(1R,2S,5R)-N-(4-methoxyphenyl)-5-methyl-2-(propan-2-yl)cyclohexane-1-carboxamide

Test material form:

solid: crystalline

Details on test material:

- Physical state: solid, whitish to white crystals
- Storage condition of test material: room temperature in the dark

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Laboratories UK Limited, Bicester, Oxon, UK
- Age at study initiation: twelve to twenty weeks old
- Weight at study initiation: 2.48 to 2.68 kg
- Housing: individually housed in suspended cages.
- Diet (ad libitum): 2030 Teklad Global Rabbit diet
- Water (ad libitum): mains drinking water
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature: 17 to 23 °C
- Relative humidity: 30 to 70 %
- Air exchanges: at least fifteen changes per hour
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g of the test material, moistened with vehicle

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 mL of distilled water

Duration of treatment / exposure:

4 hours

Observation period:

Approximately 1 hour as well as 24, 48 and 72 hours after patch removal

Number of animals:

3 rabbits

Details on study design:

TEST SITE
- Area of exposure: shaved epidermis on the dorsal/flank area
- Type of wrap used: 2.5 cm x 2.5 cm cotton gauze patch secured in position with a strip of surgical adhesive tape. The trunk of each rabbit was wrapped in an elasticated corset.

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: Four hours after application
- Washing: any residual test material removed by gentle swabbing with cotton wool soaked in distilled water.

SCORING SYSTEM: according to the Draize scale
Any other skin reactions, if present, were also recorded.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal #1

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

0

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal #1

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

0

Results 3

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal #2

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

0

Results 4

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal #2

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

0

Results 5

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal #3

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

0

Results 6

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal #3

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

0

Irritant / corrosive response data:

No evidence of skin irritation was noted during the study.
No corrosive effects were noted.

Other effects:

All animals showed expected gain in body weight 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 substance is not irritating to the skin based on an in vivo study (OECD 404). According to Regulation (EC) No 1272/2008 and subsequent adaptations, the substance does not require classification as skin irritant.

Executive summary:

The skin irritation potential of the substance was investigated according to the OECD guideline 404. A single dose of 0.5 g of the substance moistened with distilled water was applied to the intact skin of three New Zealand White rabbits and covered semi-occlusive for an exposure period of 4 hours. The test sites were examined for skin reactions and scored according to the Draize scale after 1, 24, 48 and 72 hours. Signs of skin irritation or corrosion were not observed. According to Regulation (EC) No 1272/2008 and subsequent adaptations, the substance does not require classifiication as skin irritant.