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Registration Dossier
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EC number: 220-482-8 | CAS number: 2781-11-5
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 15 Jul - 16 Dec 1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: Code of Federal Regulations, Title 49, Part 173, Appendix II
- Version / remarks:
- 1977
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OPP 81-5 (Acute Dermal Irritation)
- Version / remarks:
- 1978
- Deviations:
- yes
- Remarks:
- : no 72 h observation period
- Principles of method if other than guideline:
- - Principle of test: patch-test
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Diethyl bis(2-hydroxyethyl)aminomethylphosphonate
- EC Number:
- 220-482-8
- EC Name:
- Diethyl bis(2-hydroxyethyl)aminomethylphosphonate
- Cas Number:
- 2781-11-5
- Molecular formula:
- C9H22NO5P
- IUPAC Name:
- diethyl {[bis(2-hydroxyethyl)amino]methyl}phosphonate
- Test material form:
- liquid: viscous
- Details on test material:
- - Physical state: viscous liquid
- Colour: amber
- Expiry date: not reported
Constituent 1
- Specific details on test material used for the study:
- - Receipt date: 25 Jun 1981
- Color: amber
- Form: viscous liquid
Test animals
- Species:
- rabbit
- Strain:
- other: Stauffland albino rabbits
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Phillips Rabbitry, Soquel, USA
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 mL
- Duration of treatment / exposure:
- 4 h
- Observation period:
- Reading time points: 4 and 48 h
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: 1 inch of intact skin
- Type of wrap: gauze patch held in place with adhesive tape and wrapped with rubberized damming
REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 4 h
OBSERVATION TIME POINTS
- 4 and 48 h
SCORING SYSTEM:
- Method of calculation: as described by Draize (1965)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 4/48 hr
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: No indication of irritation. The observation time points differs from the 24/48/72 standard, however since there was no irritation observed at 4 or 48 hours, this deviation would probably not alter the conclusion.
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 4/48 hr
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: No indication of irritation. The observation time points differs from the 24/48/72 standard, however since there was no irritation observed at 4 or 48 hours, this deviation would probably not alter the conclusion.
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 4/48 hr
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: No indication of irritation. The observation time points differs from the 24/48/72 standard, however since there was no irritation observed at 4 or 48 hours, this deviation would probably not alter the conclusion.
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- other: 4/48 hr
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: No indication of irritation. The observation time points differs from the 24/48/72 standard, however since there was no irritation observed at 4 or 48 hours, this deviation would probably not alter the conclusion.
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- other: 4/48 hr
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: No indication of irritation. The observation time points differs from the 24/48/72 standard, however since there was no irritation observed at 4 or 48 hours, this deviation would probably not alter the conclusion.
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- other: 4/48 hr
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: No indication of irritation. The observation time points differs from the 24/48/72 standard, however since there was no irritation observed at 4 or 48 hours, this deviation would probably not alter the conclusion.
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 4/48 hr
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: No indication of irritation. The observation time points differs from the 24/48/72 standard, however since there was no irritation observed at 4 or 48 hours, this deviation would probably not alter the conclusion.
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 4/48 hr
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: No indication of irritation. The observation time points differs from the 24/48/72 standard, however since there was no irritation observed at 4 or 48 hours, this deviation would probably not alter the conclusion.
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 4/48 hr
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: No indication of irritation. The observation time points differs from the 24/48/72 standard, however since there was no irritation observed at 4 or 48 hours, this deviation would probably not alter the conclusion.
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- other: 4/48 hr
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: No indication of irritation. The observation time points differs from the 24/48/72 standard, however since there was no irritation observed at 4 or 48 hours, this deviation would probably not alter the conclusion.
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- other: 4/48 hr
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: No indication of irritation. The observation time points differs from the 24/48/72 standard, however since there was no irritation observed at 4 or 48 hours, this deviation would probably not alter the conclusion.
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- other: 4/48 hr
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: No indication of irritation. The observation time points differs from the 24/48/72 standard, however since there was no irritation observed at 4 or 48 hours, this deviation would probably not alter the conclusion.
- Irritant / corrosive response data:
- No adverse effects were observed for all tested animals at the time points 4 and 48 h.
- Other effects:
- - Other adverse local effects: none
- Other adverse systemic effects: none
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this study, the test material is not classified according to Regulation (EC) 1272/2008 (CLP) and to the GHS.
- Executive summary:
In a primary dermal irritation study, conducted similarly to the EPA OPP 81-5 Guideline, six female Stauffland albinorabbits were dermally exposed to (0.5mL) of undiluted test material to the dorsal area of the trunk. Test sites were covered with an occlusive dressing for 4 hours. Skin reactions of the animals were assessed at removal of the patches and 48 hours after. Irritation was scored according to the Draize scale.
The test material produced no irritation in intact skin of albino rabbits.
Mean (4/48 hrs) individual erythema score: 0.00 / 0.00 / 0.00 / 0.00 / 0.00 / 0.00.
Mean (4/48 hrs) individual oedema score: 0.00 / 0.00 / 0.00 / 0.00 / 0.00 / 0.00.
Under the conditions of this study, the test material is not classified according to Regulation (EC) 1272/2008 (CLP) and to the GHS.
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