Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
skin irritation / corrosion, other
Remarks:
In-vivo study completed
Type of information:
experimental study
Adequacy of study:
key study
Study period:
01 December to 04 December, 1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: done under GLP and OECD method

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report date:
1999

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes
Remarks:
OECD ENV/MC/CHEM(98)17

Test material

Constituent 1
Chemical structure
Reference substance name:
2,5-anhydro-4-{[4-(4-{4-[({1-[(2S,3S)- 2-(benzyloxy)pentan-3-yl]hydrazino}carbonyl)amino]phenyl}piperazin1-yl)phenoxy]methyl}-1,3,4-trideoxy-2-(2,4-difluorophenyl)-1-(1H-1,2,4-triazol-1-yl)-
EC Number:
701-059-1
Cas Number:
345217-03-0
Molecular formula:
C43H50F2N8O4
IUPAC Name:
2,5-anhydro-4-{[4-(4-{4-[({1-[(2S,3S)- 2-(benzyloxy)pentan-3-yl]hydrazino}carbonyl)amino]phenyl}piperazin1-yl)phenoxy]methyl}-1,3,4-trideoxy-2-(2,4-difluorophenyl)-1-(1H-1,2,4-triazol-1-yl)-
Test material form:
other: White solid
Details on test material:
stored at room temp in the dark.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: David Percival Ltd, Moston, Sandbank, Chesire, UK.
- Age at study initiation: 12 - 16 weeks
- Weight at study initiation: 3.03 -3.16 kg
- Housing: Individually in suspended metal cages.
- Diet: STANRAB SQC Rabbit diet, ad libitum
- Water: Mains, ad libitum
- Acclimation period: minimum of 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16° - 20°C
- Humidity (%): 43 - 52%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 hrs continous light and 12 hrs dark

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Remarks:
moistened with 0.5 ml distilled water.
Controls:
other: contralateral zone of same animal
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
4hr
Observation period:
1hr, 24hr, 48hr and 72hr after dressing removed.
Number of animals:
3
Details on study design:
Moistened test material introduced under a 25cm x 25cm cotton gauze patch.
4 hrs after application the patches were removed and any residual test material removed by gentle swabbing with cotton wool soaked in Distilled water.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: overall at 1, 24, 48 and 72 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: overall at 1, 24, 48 and 72 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 1 hr
Score:
1
Reversibility:
fully reversible within: 24 hr
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: overall at 1, 24, 48 and 72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: overall at 1, 24, 48 and 72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: overall at 1, 24, 48 and 72 h
Score:
0
Other effects:
No other adverse skin reactions were noted.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material was classified as NON-IRRITANT to rabbit skin according to the Draize classification scheme.

Executive summary:

The test material produced a primary irritation index of 0.0 and was classified as NON-IRRITANT to rabbit skin according to the Draize classification scheme.

No corrosive effects were noted.

The material did not meet the criteriaa for classification as irritant or corrosive according to EU labelling regulations.