Benzoic acid, 2-ethoxy-4-[2-[[(1S)-3-methyl-1-[2-(1-piperidinyl)phenyl]butyl]amino]-2-oxoethyl]-, ethyl ester

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

December 14-18, 1999

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-Ethoxy-4-{3-[(S)-3-methy-1-(2-piperidin-1-yl-phenyl)-butylamino]-2-oxo-propyl}-benzoic acid ethyl ester

EC Number:

604-604-0

Cas Number:

147770-06-7

Molecular formula:

C29 H40 N2 O4

IUPAC Name:

2-Ethoxy-4-{3-[(S)-3-methy-1-(2-piperidin-1-yl-phenyl)-butylamino]-2-oxo-propyl}-benzoic acid ethyl ester

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

New Zealand White Rabbits Crl:KBL (NZW) BR.
3 female animals were used.
The animals were derived from a controlled full barrier maintained breeding
system (spf).
Source: Charles River Deutschland GmbH, D-88353 Ki13legg.
According to Art. 9 .2, No. 7 of the German Act on Animal Welfare the animals
were bred for experimental purposes.
- Semi-barrier in air conditioned rooms
- Temperature: 18 ± 3 °C
- Rel. humidity: 55 ± 10%
- Artificial light, lighting regime 12: 12 hours, light 6.30 - 18.30
- Air change: at least 10 x / hour
- Free access to Altromin 2123 maintenance diet for rabbits,
rich in crude fibre, totally pathogene free-TPF
- Free access to tap water ( drinking water, municipal residue control,
microbiol. controlled periodically)
- Individually housed in ABS - plastic rabbit cages, floor 4200 cm2
- Acclimatization period 1 week

Test system

Type of coverage:

not specified

Preparation of test site:

clipped

Vehicle:

other: cottonseed oil

Controls:

yes

Amount / concentration applied:

0.5 g

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

3 female rabbits

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Applicant's summary and conclusion

Interpretation of results:

other: not classified acc. to CLP

Conclusions:

Considering the reported data of this irritation study it can be stated that the
test item AGEE 623 Amidester showed no irritant/corrosive effects.

Executive summary:

In this irritation study the test item AGEE 623 Amidester was applied to one
site of the closely clipped backs of 3 rabbits (strain NZW) at a dose of 0.5 g
per application site. The untreated other side served as control.
The application site was covered with a semi - occlusive bandage for a 4
hour - contact time.
Observations were recorded and compared to the control sites, 1 h, 24 h,
48 h and 72 hours after removal of the dressing.
The test item AGEE 623 Amidester showed no irritant effects on the intact
skin after a contact time of 4 hours.
No other clinical signs of toxicity were found.