Registration Dossier
Registration Dossier
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EC number: 282-810-6 | CAS number: 84434-11-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Only 9 day observation period
- GLP compliance:
- no
Test material
- Reference substance name:
- Ethyl phenyl(2,4,6-trimethylbenzoyl)phosphinate
- EC Number:
- 282-810-6
- EC Name:
- Ethyl phenyl(2,4,6-trimethylbenzoyl)phosphinate
- Cas Number:
- 84434-11-7
- Molecular formula:
- C18H21O3P
- IUPAC Name:
- ethyl phenyl(2,4,6-trimethylbenzoyl)phosphinate
- Details on test material:
- - Name of test material (as cited in study report): Initiator 654
- Physical state: yellow liquid
- Expiration date of the lot/batch: Oct. 1983
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- Acclimatization period: app. 8 days
One animal per cage (stainless steel with wire mesh walk floor, floor area: 40 cm x 51 cm).
Source: Gaukler, Offenbach/Main, FRG
Weight: 2.88 - 3.12kg
Room temperature: 20 - 26°C
Humidity: conventionally (about 30 - 70%)
Day/night rhythm: 12 h/12 h (6.00 - 18.00 hours/18.00 - 6.00 hours)
Diet: Ovator Solikanin 4 mm; Muskator-Werke Düsseldorf, FRG (about 130 g per animal per day)
Drinking water: About 250 ml per animal per day: fully demineralized water (Monday - Friday), tap water (Saturday/Sunday)
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated skin of the same animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): about 0.5ml - Duration of treatment / exposure:
- 4 hour
- Observation period:
- 9 days
- Number of animals:
- 3 (1male, 2 females)
- Details on study design:
- Application area: 2.5 cm x 2.5 cm
Application site: Upper third of the back or flank
Removal of the test substance at the end of the exposure period with Lutrol and Lutrol/water (1 : 1).
Readings: 30 - 60 minutes after removal of the test patches and 24 h, 48 h, and 9 d after the beginning of application.
Assessment according to Draize
Additional examinations: After sacrifice all animals are examined by gross pathology. If there are clinical signs of necroses, these are confirmed by gross-pathological examination after incision of the skin.
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
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test material failed to induce dermal irritation under the conditions of the test.
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