Registration Dossier
Registration Dossier
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EC number: 231-388-1 | CAS number: 7526-26-3
Skin irritation / corrosion
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:
- test procedure in accordance with national standard methods with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The test item (500 µL) was applied semi-occlusively to the inner surface of one ear of new Zealand white rabbits for 8 or 24 hours. For each duration 2 animals were used. The other ear served as control. After 8 and 24 hours, the ears were washed with soap and water.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Diphenyl methylphosphonate
- EC Number:
- 231-388-1
- EC Name:
- Diphenyl methylphosphonate
- Cas Number:
- 7526-26-3
- Molecular formula:
- C13H13O3P
- IUPAC Name:
- diphenyl methylphosphonate
- Details on test material:
- - Name of test material (as cited in study report): Methanphosphonsäurediphenylester
- Substance type: organic
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
male and female, 2 animals per duration
- Weight at study initiation: 3-4 kg
- Housing: single
- Diet (e.g. ad libitum): species-specific Feeding
- Water (e.g. ad libitum): ad libitum
- Acclimation period: not given
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the other ear served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 µL/animal
- Concentration (if solution): pure / unchanged - Duration of treatment / exposure:
- 8 and 24 hours
- Observation period:
- 7 days
- Number of animals:
- 2 / duration
- Details on study design:
- TEST SITE
- Area of exposure: inner surface of the ear
- Type of wrap if used: fixation of substance with band-aid
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with soap and water
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Remarks on result:
- no indication of irritation
- Remarks on result:
- other: After 8 and 24 hours and subsequent washing with soap and water, no signs of irritation were noticeable within the observation period of 7 days.
- Irritant / corrosive response data:
- not irritating
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- EU-GHS
- Conclusions:
- The test item did not show any irritating potential in rabbit ears after an exposure of 8 or 24 hours.
- Executive summary:
The test item (500 µL) was applied semi-occlusively to the inner surface of new Zealand white rabbits for 8 or 24 hours (Thyssen, 1979). For each duration 2 animals were used. The other ear served as control. After 8 and 24 hours and subsequent washing with soap and water, no signs of irritation were noticeable within the observation period of 7 days.
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