Registration Dossier
Registration Dossier
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EC number: 204-112-2 | CAS number: 115-86-6
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: guideline study, GLP, full report available. Also assessed by OECD.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Triphenyl phosphate
- EC Number:
- 204-112-2
- EC Name:
- Triphenyl phosphate
- Cas Number:
- 115-86-6
- Molecular formula:
- C18H15O4P
- IUPAC Name:
- triphenyl phosphate
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- - Physical state: yellowish, solid
- Analytical purity: 99.7%
- Purity test date: 10 jan 1989
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Breeder Interfauna UK, Ltd. Wyton, Huntington, England
- Weight at study initiation: 300-340 g
- Housing: Indiviudally housed in stainless stell cages or polyethylene cages.
- Diet (e.g. ad libitum): Standard diet Ssniff K 4 approx 100-120 g/animal/day; once per day in the morning.
- Water (e.g. ad libitum): Tap water
- Acclimation period: Prior to the initiation of treatment the animals were kept for at least 14 days in the quarantine station and monitored.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3 deg C
- Humidity (%): approx 50%
- Air changes (per hr): 10 times per hour
- Photoperiod (hrs dark / hrs light):12 hours, artificial illumination from 6 to 18hrs CET
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Amount / concentration applied:
- Concentration: 500 mg
- Duration of treatment / exposure:
- 4 hour(s)
- Observation period:
- 24, 48 and 72 hours after exposure
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 6cm2
- Type of wrap if used: Semi occlusive dressing (Fixomull Stretch Klebevlies, Beiersdorf no, 2293)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Carefully washed with water without altering the existing response or the integrity of the epidermis.
- Time after start of exposure: 4 hours
SCORING SYSTEM:
- The degree of erythema/eschar formation and odema formation was recorded as specified by DRAIZE and any serious lesions or toxic effects other than dermal irritation were also recorded.
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:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- No erythema or eshar formation and no odema formation
Any other information on results incl. tables
no signs of irritation appeared within 7 days
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- not irritating
- Executive summary:
The irritant/corrosive effects of test substance Disflamoll TP were tested on the skin of rabbits in accordance with OECD Guideline 404. Interpretation was based on the nature, intensity and reversibility of the responses. In this study, the test substance was not irritating to the skin of rabbits following an exposure period of 4 hours.
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