Registration Dossier
Registration Dossier
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EC number: 929-947-6 | CAS number: -
Toxicological information
Skin irritation / corrosion
Currently viewing:
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2007-10-25 to 2007-11-09
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- [(3R)-3-[2-hydroxy-5-(hydroxymethyl)phenyl]-3-phenylpropyl]bis(propan-2-yl)azanium (2R)-2-(acetyloxy)-2-phenylacetate
- EC Number:
- 929-947-6
- Molecular formula:
- C22H31NO2 • C19H10O4
- IUPAC Name:
- [(3R)-3-[2-hydroxy-5-(hydroxymethyl)phenyl]-3-phenylpropyl]bis(propan-2-yl)azanium (2R)-2-(acetyloxy)-2-phenylacetate
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: E010005910
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperauter in the dark
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: Ground to a powder
FORM AS APPLIED IN THE TEST (if different from that of starting material)
Solid powder
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan UK Limited, Bicester, Oxon, UK
- Age at study initiation: twelve to twenty weeks
- Weight at study initiation: 2.0 to 3.5 kg
- Housing: Suspended cages
- Diet (e.g. ad libitum): Certified rabbit diet ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: >5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23 degrees C
- Humidity (%): 30 to 70%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 3 min, 1 hour, 4 hours
- Observation period:
- 7 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- Type of wrap if used: Surgical adhesive tape and an elasticated corset
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Cotton wool soaked in distilled water
- Time after start of exposure: 3 minutes, 1 hour and 4 hours for one rabbit, and 4 hours for the remaining two
OBSERVATION TIME POINTS
1, 24, 48, and 72 hours after the removal of the test substance
SCORING SYSTEM:
- Method of calculation:
Erythema and Eschar Formation
No erythema 0
Very slight erythema (barely perceptible) 1
Well-defined erythema 2
Moderate to severe erythema 3
Severe erythema (beef redness) to eschar formation preventing grading of erythema 4
Oedema Formation
No oedema 0
Very slight oedema (barely perceptible) 1
Slight oedema (edges of area well-defined by definite raising) 2
Moderate oedema (raised approximately 1 millimetre) 3
Severe oedema (raised more than 1 millimetre and extending beyond the area of exposure) 4
Any other skin reactions, if present, were also recorded.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- After 3 min exposure
- Time point:
- other: 1 hr
- Score:
- ca. 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- After 3 min exposure
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- After 3 min exposure
- Time point:
- other: 1 hr
- Score:
- ca. 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- After 3 min exposure
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- After 1 hr exposure
- Time point:
- other: 1 hr
- Score:
- ca. 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- After 1 hr exposure
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 1 hr
- Score:
- ca. 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- After 1 hr exposure
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- After 4 hr exposure
- Time point:
- other: 1 hr
- Score:
- ca. 2
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- After 4 hr exposure
- Time point:
- 24 h
- Score:
- ca. 2
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- After 4 hr exposure
- Time point:
- 48 h
- Score:
- ca. 1
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- After 4 hr exposure
- Time point:
- 72 h
- Score:
- ca. 1
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- After 4 hr exposure
- Time point:
- 7 d
- Score:
- ca. 0
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- After 4 hr exposure
- Time point:
- other: 1 hr
- Score:
- ca. 1
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- After 4 hr exposure
- Time point:
- 24 h
- Score:
- ca. 1
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- After 4 hr exposure
- Time point:
- 48 h
- Score:
- ca. 0
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- After 4 hr exposure
- Time point:
- 72 h
- Score:
- ca. 0
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- After 4 hr exposure
- Time point:
- 7 d
- Score:
- ca. 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- After 4 hr exposure
- Time point:
- other: 1 hr
- Score:
- ca. 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- After 4 hr exposure
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- After 4 hr exposure
- Time point:
- 7 d
- Score:
- ca. 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- After 4 hr exposure
- Time point:
- other: 1 hr
- Score:
- ca. 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- After 4 hr exposure
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- After 4 hr exposure
- Time point:
- 7 d
- Score:
- ca. 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- After 4 hr exposure
- Time point:
- other: 1 hr
- Score:
- ca. 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- After 4 hr exposure
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- After 4 hr exposure
- Time point:
- 7 d
- Score:
- ca. 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- After 4 hr exposure
- Time point:
- other: 1 hr
- Score:
- ca. 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- After 4 hr exposure
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- After 4 hr exposure
- Time point:
- 7 d
- Score:
- ca. 0
- Irritant / corrosive response data:
- No corrosive effects were noted.
Any other information on results incl. tables
Sum of 24 and 72 -hour Readings (S): 4
Primary irritation index (S/6): 4/6 = 0.7
Classification: MILD IRRITANT
Applicant's summary and conclusion
- Interpretation of results:
- Category 3 (mild irritant) based on GHS criteria
- Conclusions:
- The test material produced a primary irritation index of 0.7 and was classified as a MILD IRRITANT to rabbit skin according to the Draize classification scheme.
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