Registration Dossier
Registration Dossier
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EC number: 812-111-9 | CAS number: 188959-24-2
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Active enzyme protein of Lipase, triacylglycerol (EC no. 232-619-9, CAS no. 9001-62-1, EC name: Lipase, triacylglycerol, Enzyme Class No.: 3.1.1.3)
- Molecular formula:
- Not applicable, see remarks
- IUPAC Name:
- Active enzyme protein of Lipase, triacylglycerol (EC no. 232-619-9, CAS no. 9001-62-1, EC name: Lipase, triacylglycerol, Enzyme Class No.: 3.1.1.3)
- Reference substance name:
- Protein as a constituent of enzyme deriving from the fermentation or extraction process
- Molecular formula:
- Not available
- IUPAC Name:
- Protein as a constituent of enzyme deriving from the fermentation or extraction process
- Reference substance name:
- Carbohydrates constituent of enzyme deriving from the fermentation or extraction process
- Molecular formula:
- Not available. See remarks.
- IUPAC Name:
- Carbohydrates constituent of enzyme deriving from the fermentation or extraction process
- Reference substance name:
- Inorganic salts as a constituent of enzyme deriving from the fermentation or extraction process
- Molecular formula:
- Not available. See remarks.
- IUPAC Name:
- Inorganic salts as a constituent of enzyme deriving from the fermentation or extraction process
- Reference substance name:
- Lipids as a constituent of enzyme deriving from the fermentation or extraction process
- Molecular formula:
- Not available. See remarks.
- IUPAC Name:
- Lipids as a constituent of enzyme deriving from the fermentation or extraction process
- Test material form:
- liquid
- Details on test material:
- Substance type: UVCB
Physical state: translucent tan liquid
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Constituent 5
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Covance Research Products Inc., Denver, PA
- Age at study initiation: 114 days old
- Weight at study initiation:2.8 - 3.3 kg
- Housing: The animals were housed 1/cage in suspended wire cages. Paper bedding was placed beneath the cages and changed at least three times/week.
- Diet (e.g. ad libitum): PMI Rabbit Chow (Diet #5321) provided daily
- Water (e.g. ad libitum): ad libitum
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Temperature was controlled but details were not reported
- Humidity (%): not reported
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12-hour light/dark cycle
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 mL
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 60 minutes and at 24, 48, and 72 hours following patch removal
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: 4 ply surgical gauze patch secured with non-irritating tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Residual test article was removed from the test site by gently washing with distilled water at the end of the exposure period
- Time after start of exposure: 4 hours
OBSERVATION TIME POINTS: 60 minutes and at 24, 48, and 72 hours following patch removal
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- There was no erythema or edema observed at 60 minutes, 24 hours, 48 and 72 hours after patch removal following the 4 hour exposure.
- Other effects:
- There were no abnormal physical signs noted during the observation period. All body weight changes were normal.
Any other information on results incl. tables
Erythema and Eschar Scores
Animal # |
1 |
2 |
3 |
Time after patch removal |
|
|
|
60 minutes |
0 |
0 |
0 |
24 hours |
0 |
0 |
0 |
48 hours |
0 |
0 |
0 |
72 hours |
0 |
0 |
0 |
Edema
Animal # |
1 |
2 |
3 |
Time after patch removal |
|
|
|
60 minutes |
0 |
0 |
0 |
24 hours |
0 |
0 |
0 |
48 hours |
0 |
0 |
0 |
72 hours |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No erythema or oedema were observed in any rabbits.
- Executive summary:
Three healthy New Zealand White rabbits (2 males - 1 female) were dosed dermally with the test substance in accordance with OECD Guideline 404. The test article (0.5 mL) was applied dermally to one intact site/rabbit and wrapped. The test article was kept in contact with the skin for 4 hours at which time the wrappings were removed. Dermal reactions were scored at 60 minutes and at 24, 48 and 72 hours following patch removal. The skin was also evaluated for ulceration and necrosis or any evidence of tissue destruction at these time periods. Body weights were recorded pretest and at termination.
There was no erythema or oedema observed at 60 minutes, 24 hours, 48 and 72 hours after patch removal following the 4 hour exposure. There were no abnormal physical signs noted during the observation period. All body weight changes were normal.
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