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EC number: 701-215-9 | CAS number: -
Toxicological information
Skin irritation / corrosion
Currently viewing:
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 10.05.2000 to 20.05.2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- octasodium hydrogen ({[2-({2-[(hydrogen phosphonatomethyl)(phosphomethyl)amino]ethyl}(phosphonomethyl)amino)ethyl](phosphonomethyl)amino}methyl)phosphonate hydrogen ({[2-({2-[bis(phosphonomethyl)amino]ethyl}(phosphonomethyl)amino)ethyl](phosphonomethyl)amino}methyl)phosphonate hydrogen [({2-[bis(phosphonomethyl)amino]ethyl}({2-[(hydrogen phosphonatomethyl)amino]ethyl})amino)methyl]phosphonate hydrogen {[(hydrogen phosphonatomethyl)[2-({2-[(hydrogen phosphonatomethyl)(phosphonomethyl)amino]ethyl}(phosphonomethyl)amino)ethyl]amino]methyl}phosphonate
- EC Number:
- 701-215-9
- Molecular formula:
- DTPMP-1Na C9H27N3NaO15P5 DTPMP-2Na C9H26N3Na2O15P5 DTPMP-3Na C9H25N3Na3O15P5
- IUPAC Name:
- octasodium hydrogen ({[2-({2-[(hydrogen phosphonatomethyl)(phosphomethyl)amino]ethyl}(phosphonomethyl)amino)ethyl](phosphonomethyl)amino}methyl)phosphonate hydrogen ({[2-({2-[bis(phosphonomethyl)amino]ethyl}(phosphonomethyl)amino)ethyl](phosphonomethyl)amino}methyl)phosphonate hydrogen [({2-[bis(phosphonomethyl)amino]ethyl}({2-[(hydrogen phosphonatomethyl)amino]ethyl})amino)methyl]phosphonate hydrogen {[(hydrogen phosphonatomethyl)[2-({2-[(hydrogen phosphonatomethyl)(phosphonomethyl)amino]ethyl}(phosphonomethyl)amino)ethyl]amino]methyl}phosphonate
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Myrtle's Rabbitry, Thompson Station, TN.
- Age at study initiation: 'adult'
- Weight at study initiation: 2.3 - 2.44 kg
- Housing: Individually in suspended stainless steel cages
- Diet (e.g. ad libitum): PMI certified rabbit chow #5322 (Purina Mills, Inc), ad libitum
- Water (e.g. ad libitum): Purified municipal tap water, ad libitum
- Acclimation period: Minimum of five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-22
- Humidity (%): 46-82
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: 10.05.2000 to 20.05.2000
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
-Applied under a 1 x 1 inch square patch of gauze held in place with non-irritating tape. - Duration of treatment / exposure:
- Four hours
- Observation period:
- 10 days
- Number of animals:
- 1M 5F
- Details on study design:
- TEST SITE
- Area of exposure: Dorsal area of trunk
- % coverage: No data
- Type of wrap if used: The gauze patch was held in place around the cut edges with non-irritating tape, and ingestion prevented by placing an elastic wrap over the trunk and test area.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes
- Time after start of exposure: Residual test substance was removed using gauze moistened with deionised water followed by dry gauze.
SCORING SYSTEM: Based on Draize
Any unusual observations and/or mortality were recorded. General health checks were performed twice daily. Individual body weights were obtained prior to dosing.
Animals were examined for signs of erythema and oedema and the responses were scored at 1, 24, 48, and 72 hours post patch removal, and at 10 days post patch removal.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks:
- within 48 hours
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks:
- within 48 hours
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks:
- within 48 hours
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Very slight to well-defined erythema on 6/6 test sites and very slight oedema on 3/6 test sites at the one hour scoring interval. The dermal irritation had resolved completely in all animals by day 10.
- Other effects:
- None reported.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In the in vivo skin irritation study with DTPMP (1-3Na), conducted according to OECD Test Guideline 404 and in compliance with GLP, DTPMP (1-3Na) was not irritating to rabbit skin. The primary irritation scores was calculated to be 0.75, based on the EEC dermal evaluation criteria the test substance is considered to be a non-irritant to the skin of the rabbit based on erythema and oedema. The calculated primary irritation indices for erythema and oedema were 0.61 and 0.06 respectively.
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