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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
17.11.2003 - 21.11.2003
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report date:
2003

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
adopted in 2002
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
(3S,5S)-5-[(1S,3S)-1-azido-3-{[4-methoxy-3-(3-methoxypropoxy)phenyl]methyl}-4-methylpentyl]-3-(propan-2-yl)oxolan-2-one
EC Number:
608-748-5
Cas Number:
324763-46-4
Molecular formula:
C25 H39 N3 O5
IUPAC Name:
(3S,5S)-5-[(1S,3S)-1-azido-3-{[4-methoxy-3-(3-methoxypropoxy)phenyl]methyl}-4-methylpentyl]-3-(propan-2-yl)oxolan-2-one

Test animals

Species:
rabbit
Strain:
other: New Zealand
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: breeding farm Bio Test, Konárovice
- Weight at study initiation: 3150 - 3300 g
- Housing: Animals were housed individually in cages without bedding.
- Diet: pelleted standard diet TM-MAK1 for rabbits and guinea pigs (Bergman, Kocanda Mill), ad libitum
- Water: tap water, ad libitum
- Acclimation period: 5 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15 - 21
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES:
From: 17.11.2003
To: 21.11.2003

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
other: Not required, the untreated sites of each animal served as control.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g, moistened with water
Duration of treatment / exposure:
4 h
Observation period:
72 h
Reading time points: 1, 24, 48 and 72 h
Number of animals:
3
Details on study design:
TEST SITE
- Type of wrap if used: The applied test substance was covered by a gauze patch, foil and cellulose cotton and held in place with non-irritant tape (Spofaplast).

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
over all 3 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritation parameter:
edema score
Basis:
mean
Remarks:
over all 3 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritant / corrosive response data:
No irritative effect on skin was observed in any animal during the observation period.

Any other information on results incl. tables

In the course of study no other signs of toxicity of the test substance were observed in test animals.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
According to REGULATION (EC) No 1272/2008 (CLP) the test substance does not require classification for skin irritation.

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