Registration Dossier
Registration Dossier
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EC number: 939-595-5 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Apr 1987
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline conform study with restricted reporting
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- not specified
Test material
- Reference substance name:
- potassium diethyl octylphosphonate ethyl octylphosphonate
- EC Number:
- 939-595-5
- IUPAC Name:
- potassium diethyl octylphosphonate ethyl octylphosphonate
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- bw: 3.1 - 4.0 kg
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.5 mL
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 30 - 60 min post application
24 hours post application
48 hours post application
72 hours post application
7 d post application
14 d post application
21 d post application - Number of animals:
- 3
- Details on study design:
- no data
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within:
- Remarks on result:
- other: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- fully reversible within:
- Remarks on result:
- other: 21 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- fully reversible within:
- Remarks on result:
- other: 21 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within:
- Remarks on result:
- other: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within:
- Remarks on result:
- other: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within:
- Remarks on result:
- other: 14 days
- Irritant / corrosive response data:
- Mean erythema score (all animals): 2.2
Mean edema score (all animals): 0.6
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- With reference the reported scores and the reported reversiblity within 21 days Reaction mass of potassium ethyl octylphosphonate and diethyl octylphosphonate has to be classified as irritant to the skin (H 315: Causes skin irritation) according to the criteria laid down in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).
- Executive summary:
Reaction mass of potassium ethyl octylphosphonate and diethyl octylphosphonate was tested for its skin irritant properties in 3 New Zealand rabbits. The study was performed according to OECD Guideline 404.
With reference the reported scores and the reported reversiblity within 21 days Reaction mass of potassium ethyl octylphosphonate and diethyl octylphosphonate has to be classified as irritant to the skin (H 315: Causes skin irritation) according to the criteria laid down in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).
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