Registration Dossier
Registration Dossier
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EC number: 413-330-9 | CAS number: 134724-55-3
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1996
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- Justification for type of information:
- None
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Principles of method if other than guideline:
- None
- GLP compliance:
- yes
Test material
- Reference substance name:
- 3-phenyl-7-[4-(tetrahydrofurfuryloxy)phenyl]-1,5-dioxa-s-indacen-2,6-dione
- EC Number:
- 413-330-9
- EC Name:
- 3-phenyl-7-[4-(tetrahydrofurfuryloxy)phenyl]-1,5-dioxa-s-indacen-2,6-dione
- Cas Number:
- 134724-55-3
- Molecular formula:
- C27H20O6
- IUPAC Name:
- 6-{4-[(oxolan-2-yl)methoxy]phenyl}-12-phenyl-4,10-dioxatricyclo[7.3.0.0^{3,7}]dodeca-1(12),2,6,8-tetraene-5,11-dione
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- None
Constituent 1
In vitro test system
- Test system:
- other: dermal application
- Source species:
- rabbit
- Source strain:
- New Zealand White
- Details on animal used as source of test system:
- TEST ANIMALS- Source: Kitayama Labes Co., Ltd., Japan- Age at study initiation: 9 -10 weeks old- Weight at study initiation: 2.42 - 2.90 kg- Housing: Individually housed in aluminium cages.- Diet (e.g. ad libitum): 100 g/day diet (RC-4, Oriental Yeast Co., Ltd)- Water (e.g. ad libitum): tap water ad libitum- Acclimation period: 25- 26 daysENVIRONMENTAL CONDITIONS- Temperature (°C): 22 +-2 °C- Humidity (%): 55 +- 15%- Air changes (per hr): 10 times per hour- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle
- Justification for test system used:
- None
- Vehicle:
- water
- Details on test system:
- None
- Amount/concentration applied:
- TEST MATERIAL- Amount(s) applied (volume or weight with unit): 10gm mixed with 10ml water- Concentration (if solution): 0.75 mlVEHICLE- Amount(s) applied (volume or weight with unit): 10ml water
- Duration of treatment / exposure:
- 72 hours
- Duration of post-treatment incubation (if applicable):
- None
- Number of replicates:
- None
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS- Source: Kitayama Labes Co., Ltd., Japan- Age at study initiation: 9 -10 weeks old- Weight at study initiation: 2.42 - 2.90 kg- Housing: Individually housed in aluminium cages.- Diet (e.g. ad libitum): 100 g/day diet (RC-4, Oriental Yeast Co., Ltd)- Water (e.g. ad libitum): tap water ad libitum- Acclimation period: 25- 26 daysENVIRONMENTAL CONDITIONS- Temperature (°C): 22 +-2 °C- Humidity (%): 55 +- 15%- Air changes (per hr): 10 times per hour- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- not specified
- Vehicle:
- other: none
- Controls:
- yes
- Amount / concentration applied:
- 500 mg
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- Skin reactions of erythema and edema were scored 0.5, 24, 48 and 72 hours after removal of patch according to the method of Draize.
- Number of animals:
- 3
- Details on study design:
- None
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- mean score 1
- Time point:
- other: overall at 24,48 and 72h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- other: overall at 24,48 and 72h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- other: overall at 24,48 and 72h
- Score:
- 0
- Irritation parameter:
- erythema score
- Max. score:
- 0
- Remarks on result:
- other: Max. duration: 0 d.; Max. value at end of observation period: 0 (related to all animals)
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- other: overall at 24,48 and 72h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- other: overall at 24,48 and 72h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- other: overall at 24,48 and 72h
- Score:
- 0
- Irritation parameter:
- edema score
- Max. score:
- 0
- Remarks on result:
- other: Max. duration: 0 d.; Max. value at end of observation period: 0 (related to all animals)
- Irritant / corrosive response data:
- No reactions were observed in any rabbits during observation period.
- Other effects:
- None
Any other information on results incl. tables
None
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The irritation potential of the material was found to be 0, and therefore classified as non irritating.
- Executive summary:
The aim of this study was to determine the potential of FAT 40554 to induce irritation to rabbits skin. The study was carried out according to GLP methodology and OECD Guideline 404; 92/69/EEC, B.4.
One half of the test material was spread on the 1 inch square lint patch and applied to the intact skin of 3 rabbits with an occlusive tape for 4 hours.
At the end of exposure period, the patches were removed from the skin and the treated area was wiped to remove any remaining material by absorbent cotton dipped in acetone.
Skin reactions of erhthema and edema were scored 0.5, 24, 48 and 72 hours after removal of patch according to the method of Draize. The evaluation of irritation potency of the test material was performed by using primary irritation score.
No skin reactions such as erythema and edema were observed in any rabbits during the observation period. primary irritation score was 0. Therefore, the irritation potential of the material was judged to be negative.
According to the EEC classification of the results obtained 0.5 to 72 hours after removing the bandages FAT 40554 can be classified as non-irritant in albino rabbits.
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