Registration Dossier
Registration Dossier
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EC number: 701-337-2 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- November 10, 1988 – November 13, 1988
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1981
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- 1984
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes
- Remarks:
- Statement of Compliance
Test material
- Reference substance name:
- 3-[(diphenoxyphosphoryl)oxy]phenyl diphenyl phosphate
- EC Number:
- 701-337-2
- Cas Number:
- not available
- Molecular formula:
- C30H24O8P2
- IUPAC Name:
- 3-[(diphenoxyphosphoryl)oxy]phenyl diphenyl phosphate
- Details on test material:
- - Name of test material (as cited in study report): CR 733-S
- Physical state: Liquid
- Lot/batch No.: confidential
- Storage condition of test material: At room temperature in the dark
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: The Broekman Institute, Someren, The Netherlands
- Age at study initiation: 18 weeks
- Weight at study initiation: 3391, 3435, 3699 gr.
- Housing: Individually housed in a plastic cage with a perforated floor
- Diet: Standard laboratory animal diet (100 g per day, LKK-20, diameter 4 mm), obtained from Hope Farms, Woerden, The Netherlands
- Water: Tap-water (via automatic nozzles) ad libitum
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 20
- Humidity (%): 40 - 70
- Air changes (per hr): Air conditioned
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: No data
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Left doral flank of each animal being covered with the sane dressing without test substance
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution): undiluted - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 45 minutes, and 24, 48 and 72 hours after removal of the patches
- Number of animals:
- 3 females
- Details on study design:
- TEST SITE
- Area of exposure: right dorsal flank clipped approx. 10cm x 10cm, application of test substance on a 6 cm2 gauze patch
- Type of wrap if used: gauze patch was attached with a drop of petrolatum to aluminium foil and mounted on permeable tape (Micropore, 3M, St.Paul, USA). The animals were wrapped in flexible bandage (Coban, 3M, St. Paul, USA).
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Remaining test substance was removed, using a dry tissue and subsequently a tissue moistened with tap-water.
- Time after start of exposure: 4 hours
SCORING SYSTEM: Subjective numerical according to OECD Guideline 404 (Erythema and Eschar formation / Oedema formation). Maximum possible score: 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Remarks:
- modified
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- The primary skin irritation score for erythema and oedema was 0 for all 3 animals at each observation time. The test substance caused no adverse effects to the skin in any of the animals.
No signs of systemic intoxication were observed in any of the rabbits. - Other effects:
- None
Any other information on results incl. tables
Not relevant
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on these results and the calculated primary irritation index (modified) of 0, the test substance should be considered as non-irritating to the skin. Applying the EU criteria for classification and labelling of dangerous substances, the test substance need not be labelled as a skin irritant.
- Executive summary:
A sample of CR 733-S was tested in the rabbit primary skin irritation/corrosion test. The right dorsal flank skin of 3 female albino rabbits was exposed to 0.5 ml of the test substance for 4 hours using semi-occlusive dressings. The test substance caused no adverse effects to the skin in any of the animals. The primary skin irritation index amounted to 0. Based on these results, the test substance should be considered as non-irritating to the skin. According to the criteria laid down in Annex VI of the EEC Council Directive 67/548/EEC (amended by Directive 83/467/EEC), and outlined in 1272/2008/EC (CLP/EU-GHS), the test substance need not be labelled as a skin irritant.
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