Registration Dossier
Registration Dossier
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EC number: 947-805-1 | CAS number: 213077-23-7
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:
- 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- July, 1992
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Didodecyl nonylphenyl phosphite
- EC Number:
- 252-457-2
- EC Name:
- Didodecyl nonylphenyl phosphite
- Cas Number:
- 35239-35-1
- Molecular formula:
- C39-H73-O3-P
- IUPAC Name:
- Phosphorous acid, didodecyl nonylphenyl ester
- Reference substance name:
- Dodecyl bis(4-nonylphenyl) phosphite
- EC Number:
- 284-117-4
- EC Name:
- Dodecyl bis(4-nonylphenyl) phosphite
- Cas Number:
- 84787-76-8
- Molecular formula:
- C42-H71-O3-P
- IUPAC Name:
- Phosphorous acid, dodecyl bis(4-nonylphenyl) ester
- Reference substance name:
- 4-nonylphenyl ditridecyl phosphite
- EC Number:
- 284-119-5
- EC Name:
- 4-nonylphenyl ditridecyl phosphite
- Cas Number:
- 84787-77-9
- Molecular formula:
- C41-H77-O3-P
- IUPAC Name:
- Phosphorous acid, 4-nonylphenyl ditridecyl ester
- Reference substance name:
- Bis(4-nonylphenyl) tridecyl phosphite
- EC Number:
- 284-120-0
- EC Name:
- Bis(4-nonylphenyl) tridecyl phosphite
- Cas Number:
- 84787-78-0
- Molecular formula:
- C43-H73-O3-P
- IUPAC Name:
- Phosphorous acid, bis(4-nonylphenyl) tridecyl ester
- Reference substance name:
- Tris(nonylphenyl) phosphite
- EC Number:
- 247-759-6
- EC Name:
- Tris(nonylphenyl) phosphite
- Cas Number:
- 26523-78-4
- IUPAC Name:
- tris(2-nonylphenyl) phosphite
- Reference substance name:
- Didodecyl phosphonate
- EC Number:
- 244-325-8
- EC Name:
- Didodecyl phosphonate
- Cas Number:
- 21302-09-0
- Molecular formula:
- C24H51O3P
- IUPAC Name:
- Di(n-dodecyl)hydrogen phosphate
- Reference substance name:
- Phenol, 4-nonyl-, branched
- EC Number:
- 284-325-5
- EC Name:
- Phenol, 4-nonyl-, branched
- Cas Number:
- 84852-15-3
- Molecular formula:
- C15H24O
- IUPAC Name:
- 4-Nonylphenol, branched
- Test material form:
- liquid
Constituent 1
Constituent 2
Constituent 3
Constituent 4
impurity 1
impurity 2
impurity 3
- Specific details on test material used for the study:
- TEST MATERIAL NAME (as stated in study report): TK 12437 (Trade Name: Irgastab CH 302)
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Sponsor; Batch No. 08520495
- Expiration date of the lot/batch: July, 1996
- Purity: within the product specifications
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dr. K. Thomae GMBH, Chemisch-pharmazeutische Fabrik, D-7950 Biberach/Riss
- Weight at study initiation: 2360 to2560 g
- Housing: individually in metal cages
- Diet (e.g. ad libitum): Standard rabbit pellet - Nafag No. 814, Gossau, Switzerland; ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/-3 °C
- Humidity (%): 30-70 %
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- 0.5 mL
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 7 days
- Number of animals:
- 3 female animals
- Details on study design:
- An area of at least 36 cm was shaved on both flanks of the animals approximately 24 hours before treatment. A gauze patch (approx.. 12-16 cm ) bearing 0.5 ml of the test article was applied to the right flank of each animal. A control gauze patch was applied to the contralateral flank. Both patches were moistened before application with distilled water.
The patches were loosely covered with an aluininum foil (approx. 36 cm ) and held in place for 4 hours by an adhesive tape (Isoplast, Isoplast AG, CH-5200 Brugg).
The animals were checked daily for systemic Symptoms and mortality (only findings reported).
The skin reactions were evaluated 1, 24, 48, and 72 hours after removing the gauze patches according to the OECD scoring system.
Bodyweight was recorded at start and on days 3 and 7 of the test.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Irritant / corrosive response data:
- see attached data table
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Not classified by CLP Criteria
- Conclusions:
- In a guideline (OECD 404) in vivo skin irritation study, Irgastab CH 302 was not classified as a non-irritant to the skin of albino rabbits.
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