Registration Dossier
Registration Dossier
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EC number: 419-310-6 | CAS number: 125248-71-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- May 09, 1995 - May 16, 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- July 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- 31 July 1992
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- -
- EC Number:
- 419-310-6
- EC Name:
- -
- Cas Number:
- 125248-71-7
- Molecular formula:
- C39H44O10
- IUPAC Name:
- 2-methyl-4-(4-{[6-(prop-2-enoyloxy)hexyl]oxy}benzoyloxy)phenyl 4-{[6-(prop-2-enoyloxy)hexyl]oxy}benzoate
- Test material form:
- solid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: SAVO-Ivanovas, Kisslegg
- Age at study initiation: about 31 to 32 weeks
- Weight at study initiation: 3.81 (3.51 - 4.20) kg
- Housing: separately in cages type KK 017 (floor area: 75 x 54.5 = 4087 cm2 , height: 38 cm; manufacturer: Hulskamp) on metal grids
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 - 18
- Humidity (%): 40 - 50
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- other: aqua pro injectione
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 g
VEHICLE
- Amount applied: some drops
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1 hour, 24, 48, and 72 hours, and on a period of further 4 days
- Number of animals:
- 3 (2 males and 1 female)
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm2
- Type of wrap if used: perforated polyethylene feil, which was kept in place by a leather sleeve
REMOVAL OF TEST SUBSTANCE
- Washing: Yes
- Time after start of exposure: 4 hours
OBSERVATION TIME POINTS
1 hour, 24, 48, and 72 hours, and on a period of further 4 days
SCORING SYSTEM:
- Method of calculation: According to OECD 404
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:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Other effects:
- - Other adverse local effects:
none
- Other adverse systemic effects: none
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item showed no skin irritation potential in the study according to OECD Guideline 404.
- Executive summary:
To test for primary skin irritation, 0.5 g of the test material was mixed with some drops of aqua pro injectione to ensure good contact to the skin, spread onto patches, and then applied to the intact skin of three previously shaven rabbits for a 4-hour period under semiocclusive conditions.
The first examination of the treated skin sites followed 1-hour after removal of the patches. Then, examinations were performed daily for further 7 days. Under the given experimental conditions no irritations in the treated areas were observed. Therefore, the test item is not considered to be irritating to skin.
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