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EC number: 287-370-9 | CAS number: 85480-89-3
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:
- October - November 1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study is carried out according to a protocol which is equivalent to current guideline, but not compliant with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- other: HLE protocol number P518/22/6/-/553/s/Rev.1
- GLP compliance:
- no
Test material
- Reference substance name:
- EDTMP-xCaxNa
- IUPAC Name:
- EDTMP-xCaxNa
- Reference substance name:
- [ethylenebis[nitrilobis(methylene)]]tetrakisphosphonic acid, calcium sodium salt
- EC Number:
- 287-370-9
- EC Name:
- [ethylenebis[nitrilobis(methylene)]]tetrakisphosphonic acid, calcium sodium salt
- Cas Number:
- 85480-89-3
- Molecular formula:
- C6H20-2x-yN2O12P4.xCa.yNa
- IUPAC Name:
- x calcium y sodium {ethane-1,2-diylbis[nitrilobis(methylene)]}tetrakis(phosphonate)
- Reference substance name:
- 287-89-3
- IUPAC Name:
- 287-89-3
- Details on test material:
- - Name of test material (as cited in study report): ethylenediamine tetra (methylene phosphonic acid)
- Physical state: white powder
-EDTMP-xCa.xNa 26%, NaCl 12%, and water 62%. Phosphonate content ca. 92%.
Constituent 1
Constituent 2
Constituent 3
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: morton Commercial Rabbits, Parsonage Farm, Stansted, Essex
- Weight at study initiation: >2 kg
- Housing: individually housed in grid floor cages in a single room with fan controlled circulation
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: minimum of 3 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 14, lower limit
- Photoperiod (hrs dark / hrs light): natural lighting conditions supplemented with fluorescent lighting during working hours (08.45 - 17.00)
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g - Duration of treatment / exposure:
- 24 hours
- Observation period:
- 72 hours
- Number of animals:
- 6 males
- Details on study design:
- TEST SITE
- Area of exposure: back
- Type of wrap if used: gauze pad under which the test material was held was held in place by a strip of adhesive impermeable plaster which was wrapped around the trunk of the animal.
SCORING SYSTEM: Draize, 1959
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: intact skin, six animals
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: intact skin, six animals
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 72 h
- Score:
- 0.2
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: abraded skin, six animals
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 72 h
- Score:
- 0.1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: abraded skin, six animals
- Irritant / corrosive response data:
- The sum of 24 hour and 72 hour values for erythema and oedema on intact and abraded skin (48 scores) were divided by 24 to give the primary irritation index of the test article. 0 = non-irritant, >0-2 = slight, >2-5 = moderate, >5 = severe.
Very slight erythema was noted in 2 abraded sites at the 24 hour observation. One abraded site also showed very slight oedema at this time. The skin was normal at the 72 hour observation. A primary irritation index of 0.1 was obtained. Test article is therefore considered a slight skin irritant in this report. - Other effects:
- None reported.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- All readings were 0 at 24 and 72 hours when test material was applied onto intact skin, as reported in a study conducted according to a protocol which is equivalent to current guideline but not compliant with GLP. The result would not trigger classification according to current regulation (EC 1272/2008).
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