Registration Dossier
Registration Dossier
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EC number: 278-355-8 | CAS number: 75980-60-8
Toxicological information
Skin irritation / corrosion
Currently viewing:
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Federal Register 38, No 187, §1500 .41, p27029, 27 Sept 1973
- GLP compliance:
- no
Test material
- Reference substance name:
- Diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide
- EC Number:
- 278-355-8
- EC Name:
- Diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide
- Cas Number:
- 75980-60-8
- Molecular formula:
- C22H21O2P
- IUPAC Name:
- (mesitylcarbonyl)(diphenyl)phosphine oxide
- Details on test material:
- - Name of test material (as cited in study report): Initiator 554
- Analytical purity: >98%
- Physical state: crystalline
- Storage condition of test material: protected from light
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Gaukler
- Age at study initiation: not reported
- Weight at study initiation: mean 3.04 kg for male, 3.12 for female
- Diet: Ssniff from the company INTERMAST, ad libitum
- Water: ad libitum
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: abraded and intact
- Vehicle:
- water
- Controls:
- other: untreated skin of same animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): 50% in water - Duration of treatment / exposure:
- 24 hours
- Observation period:
- 8 days (observations at 24h, 48h, 72h, and day8)
- Number of animals:
- 2 males and 4 females
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
SCORING SYSTEM: as described in OECD guideline 404
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Remarks:
- intact application site
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: mean 24-48-72-hour score for abraded application site was 1, fully reversible within 72 hours
- Irritation parameter:
- edema score
- Remarks:
- intact application site
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: mean 24-48-72-hour score for abraded application site was 0.67, fully reversible within 48 hours
- Irritation parameter:
- erythema score
- Remarks:
- intact application site
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: mean 24-48-72-hour score for abraded application site was 0.33, also fully reversible within 48 hours
- Irritation parameter:
- edema score
- Remarks:
- intact application site
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: mean 24-48-72 hour score for abraded application site was also 0
- Irritation parameter:
- erythema score
- Remarks:
- intact application site
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: mean 24-48-72-hour score for abraded application site was 1.33, fully reversible within 8 days
- Irritation parameter:
- edema score
- Remarks:
- intact application site
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: mean 24-48-72-hour score for abraded application site was 0.67, also fully reversible within 48 hours
- Irritation parameter:
- erythema score
- Remarks:
- intact application site
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- ca. 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: mean 24-48-72-hour score for abraded application site was 1, fully reversible within 72 hours
- Irritation parameter:
- edema score
- Remarks:
- intact application site
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- ca. 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: mean 24-48-72-hour score for abraded application site was 0.33, also fully reversible within 48 hours
- Irritation parameter:
- erythema score
- Remarks:
- intact application site
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- ca. 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: mean 24-48-72-hour score for abraded application site was 1.33, fully reversible within 8 days
- Irritation parameter:
- edema score
- Remarks:
- intact application site
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: mean 24-48-72-hour score for abraded application site was 0.67, fully reversible within 48 hours
- Irritation parameter:
- erythema score
- Remarks:
- intact application site
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- ca. 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: mean 24-48-72-hour score for abraded application site was 0.33, also fully reversible within 48 hours
- Irritation parameter:
- edema score
- Remarks:
- intact application site
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: mean 24-48-72-hour score for abraded application site was also 0
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Remarks:
- of the 6 tested anmals
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- erythema score
- Remarks:
- intact application site
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 0.6
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours in 5 animals or 8 days in one animal
- Remarks on result:
- other: mean 24-48-72-hour score for abraded application site was 0.9, also fully reversible within 72 hours in 5 animals or 8 days in 1 animal
- Irritation parameter:
- edema score
- Remarks:
- intact application site
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: mean 24-48-72-hour score for abraded application site was 0.4, also fully reversible within 48 hours
- Other effects:
- No signs of systemic toxicity observed during necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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