Registration Dossier
Registration Dossier
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EC number: 206-056-4 | CAS number: 298-07-7
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:
- other: scientifically acceptable and sufficient documented
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
- Principles of method if other than guideline:
- 500 µl/animal of bis(2-ethylhexyl) hydrogen phosphate was applied to the inner surface of one ear per animal; exposure time was 1, 4, or 8 hour(s). The test substance was fixed by a plaster. After the exposition the test substance was removed with water and soap/plantoil. The post exposure observation time was 7 days.
- GLP compliance:
- no
Test material
- Reference substance name:
- Bis(2-ethylhexyl) hydrogen phosphate
- EC Number:
- 206-056-4
- EC Name:
- Bis(2-ethylhexyl) hydrogen phosphate
- Cas Number:
- 298-07-7
- Molecular formula:
- C16H35O4P
- IUPAC Name:
- bis(2-ethylhexyl) hydrogen phosphate
- Details on test material:
- no data
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other:
- Controls:
- not required
- Duration of treatment / exposure:
- 1, 4, or 8 hour(s)
- Observation period:
- 7 days
- Number of animals:
- 1 animal/exposure period
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24, 48, and 72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: exposure period: 1 hour
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 24, 48, and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable - score = 0 at any time point
- Remarks on result:
- other: exposure time: 1hour
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24, 48, and 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: exposure period: 4 hours
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 24, 48, and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable - score = 0 at any time point
- Remarks on result:
- other: exposure period: 4 hours
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 24, 48, and 72 h
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: exposure period: 8 hours
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 24, 48, and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable - score = 0 at any time point
- Remarks on result:
- other: exposure period: 8 hours
- Other effects:
- A surface corrosivity was observed at an application period of 4 to 8 hours.
Any other information on results incl. tables
exposure 1 hour: edema = 0 at any time point; erythema was not fully reversible within 7 days, the test substance was sligt to moderate irritant.
exposure 4 or 8 hours: edema = 0 at any time point; erythema was not fully reversible within 7 days, the test substance was strong irritating and corrosive to the skin surface.
Applicant's summary and conclusion
- Interpretation of results:
- corrosive
- Remarks:
- Migrated information
- Executive summary:
500 µl/animal of bis(2-ethylhexyl) hydrogen phosphate was applied to the inner surface of one ear per animal; exposure time was 1, 4, or 8 hour(s). The test substance was fixed by a plaster. After the exposition the test substance was removed with water and soap/plantoil. The post exposure observation time was 7 days.
Exposure 1 hour: edema = 0 at any time point; erythema was not fully reversible within 7 days, the test substance was slight to moderate irritant.
Exposure 4 to 8 hours: edema = 0 at any time point; erythema was not fully reversible within 7 days, the test substance was strong irritating to the skin surface. A surface corrosivity was observed at an application period of 4 to 8 hours.
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